PRD 2013

LAS VEGAS – Centralized pain or sensitization occurs in most patients with fibromyalgia and can be identified in 20%-30% of patients with other pain states, such as rheumatoid arthritis, lupus, low back pain, and osteoarthritis, according to Dr. Daniel J. Clauw.

This has implications for both diagnosis and treatment of these conditions. However, current paradigms for diagnosis and treatment are antiquated, Dr. Clauw, professor of anesthesiology and medicine, and director of the chronic pain and fatigue research center at the University of Michigan, Ann Arbor, said at the annual Perspectives in Rheumatic Diseases conference.

There is no chronic pain state in which the degree of damage or inflammation in the periphery correlates well with the level of pain the patient experiences, and yet, existing diagnostic paradigms – as well as the terms used to describe chronic pain states – imply otherwise, he explained.

In fact, until recently it was typically assumed that when a disparity between peripheral findings and pain existed, the problem was a psychological one, he said.

In reality, there are numerous nonpsychological neurobiologic factors that affect pain sensitivity, and these are operative in many chronic pain states. Thus, it is imperative that the diagnostic and therapeutic paradigms be modified to better identify and treat "central pain," he said.

Centralized pain is pain in which the spinal cord and/or brain play a much bigger role than the peripheral nervous system. In patients with centralized pain, the pain is more associated with pain processing pathways than with "peripheral nociceptive input out at the periphery that you will make better with nonsteroidal anti-inflammatory drugs, opioids, and surgical procedures," Dr. Clauw said.

"The problem is the diseases don’t tell us which pain state someone has," he added.

Certain clinical characteristics can provide clues, however. Among them are multifocal pain, use of neuropathic verbal descriptors of pain, higher current and lifetime history of pain, the presence of multiple other somatic symptoms, and sensitivity to multiple sensory stimuli.

"When someone centralizes their pain, they don’t have just pain any more, they have a lot of other central nervous system symptoms that are also coming from the brain, including fatigue, memory problems, sleep disturbances," he said, noting that when a patient presents with multifocal pain accompanied by these other symptoms, this should be "a blinking neon light that this person has centralized their pain."

Additionally, patients with centralized pain have a wide continuum of pain, may experience exacerbation because of stressors, and may have a generally normal physical examination except for diffuse tenderness and nonspecific neurologic signs. This type of pain is 1.5 to 2 times more common in women than men and has strong genetic underpinnings, so a family history can be helpful in identifying patients with centralized pain, Dr. Clauw noted.

Studies suggest that a number of genes that may be involved in the process, including the gene encoding catecholamine-O-methyltransferase (COMT), certain alleles of which are associated with a threefold increased risk of developing different types of chronic pain conditions, he said.

A number of pharmacologic agents have been studied for central pain; the strongest evidence exists for dual reuptake inhibitors (including tricyclic compounds, selective-norepinephrine reuptake inhibitors, and norepinephrine-selective reuptake inhibitors), and the anticonvulsants gabapentin and pregabalin. Modest evidence exists for tramadol, older less-selective selective-serotonin reuptake inhibitors, gamma-hydroxybutyrate, and low-dose naltrexone. Weak evidence suggests a benefit with cannabinoids (although evidence of benefit is increasing), growth hormone, 5-hydroxytryptamine, tropisetron, S-adenosyl-L-methionine. There is no evidence with respect to opioids, corticosteroids, nonsteroidal antiinflammatory drugs, benzodiazepine and nonbenzodiazepine hypnotics, and guaifenesin.

None of the available pharmacologic agents have anything more than modest efficacy when used as stand-alone therapy, he said, stressing the importance of also using nonpharmacologic therapies in patients with centralized pain.

The nonpharmacologic options are similar for any chronic pain state, Dr. Clauw said, noting that strong evidence exists for education, aerobic exercise, and cognitive-behavior therapy. Modest evidence exists for strength training, hypnotherapy, biofeedback, balneotherapy, yoga, and tai chi. Weak evidence suggests a possible benefit with acupuncture, chiropractic therapy, manual and massage therapy, electrotherapy, and ultrasound. No evidence exists for trigger point injections and flexibility exercise.

Many of the particularly useful nonpharmacologic therapies, including cognitive-behavior therapy or exercise, are rarely used in clinical practice, he noted.

An approach known as the ExPRESS approach to chronic pain can help improve outcomes by addressing the various factors involved in centralized pain. ExPRESS stands for exercise, psychiatric comorbidity, regaining function, education, sleep hygiene, and stress management, he said.

The approach was proposed by Afton L. Hassett, Psy.D., and Richard N. Gevirtz, Ph.D., in a 2009 study (Rheum. Dis. Clin. North Am. 2009;35:393-407), which stresses the importance of providing comprehensive care for patients with chronic pain by addressing each of these interrelated factors.

It doesn’t matter where the pain is coming from. Long-term pain increases stress levels, decreases sleep and exercise, and can lead to social isolation – all things that can make pain worse. Thus, a change in the "volume control" of the central nervous system isn’t necessarily to blame when a patient experiences worsening over time, rather it may be the accumulation of these other factors, he said at the meeting held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

"Unless and until you treat these patients with exercise, education, and cognitive-behavioral therapy ... you’re not going to make chronic pain patients better, and you’re certainly not going to make centralized pain patients better unless you aggressively use [these tools]," he said.

Dr. Clauw has been a consultant for Merck, UCB, Cypress Biosciences, Eli Lilly, Jazz Pharmaceuticals, Pierre Fabre Pharmaceuticals, Pfizer, Nuvo Research, and Forest Laboratories, and has received grant support from Nuvo Research and Forest Laboratories.

LAS VEGAS – Centralized pain or sensitization occurs in most patients with fibromyalgia and can be identified in 20%-30% of patients with other pain states, such as rheumatoid arthritis, lupus, low back pain, and osteoarthritis, according to Dr. Daniel J. Clauw.

This has implications for both diagnosis and treatment of these conditions. However, current paradigms for diagnosis and treatment are antiquated, Dr. Clauw, professor of anesthesiology and medicine, and director of the chronic pain and fatigue research center at the University of Michigan, Ann Arbor, said at the annual Perspectives in Rheumatic Diseases conference.

There is no chronic pain state in which the degree of damage or inflammation in the periphery correlates well with the level of pain the patient experiences, and yet, existing diagnostic paradigms – as well as the terms used to describe chronic pain states – imply otherwise, he explained.

In fact, until recently it was typically assumed that when a disparity between peripheral findings and pain existed, the problem was a psychological one, he said.

In reality, there are numerous nonpsychological neurobiologic factors that affect pain sensitivity, and these are operative in many chronic pain states. Thus, it is imperative that the diagnostic and therapeutic paradigms be modified to better identify and treat "central pain," he said.

Centralized pain is pain in which the spinal cord and/or brain play a much bigger role than the peripheral nervous system. In patients with centralized pain, the pain is more associated with pain processing pathways than with "peripheral nociceptive input out at the periphery that you will make better with nonsteroidal anti-inflammatory drugs, opioids, and surgical procedures," Dr. Clauw said.

"The problem is the diseases don’t tell us which pain state someone has," he added.

Certain clinical characteristics can provide clues, however. Among them are multifocal pain, use of neuropathic verbal descriptors of pain, higher current and lifetime history of pain, the presence of multiple other somatic symptoms, and sensitivity to multiple sensory stimuli.

"When someone centralizes their pain, they don’t have just pain any more, they have a lot of other central nervous system symptoms that are also coming from the brain, including fatigue, memory problems, sleep disturbances," he said, noting that when a patient presents with multifocal pain accompanied by these other symptoms, this should be "a blinking neon light that this person has centralized their pain."

Additionally, patients with centralized pain have a wide continuum of pain, may experience exacerbation because of stressors, and may have a generally normal physical examination except for diffuse tenderness and nonspecific neurologic signs. This type of pain is 1.5 to 2 times more common in women than men and has strong genetic underpinnings, so a family history can be helpful in identifying patients with centralized pain, Dr. Clauw noted.

Studies suggest that a number of genes that may be involved in the process, including the gene encoding catecholamine-O-methyltransferase (COMT), certain alleles of which are associated with a threefold increased risk of developing different types of chronic pain conditions, he said.

A number of pharmacologic agents have been studied for central pain; the strongest evidence exists for dual reuptake inhibitors (including tricyclic compounds, selective-norepinephrine reuptake inhibitors, and norepinephrine-selective reuptake inhibitors), and the anticonvulsants gabapentin and pregabalin. Modest evidence exists for tramadol, older less-selective selective-serotonin reuptake inhibitors, gamma-hydroxybutyrate, and low-dose naltrexone. Weak evidence suggests a benefit with cannabinoids (although evidence of benefit is increasing), growth hormone, 5-hydroxytryptamine, tropisetron, S-adenosyl-L-methionine. There is no evidence with respect to opioids, corticosteroids, nonsteroidal antiinflammatory drugs, benzodiazepine and nonbenzodiazepine hypnotics, and guaifenesin.

None of the available pharmacologic agents have anything more than modest efficacy when used as stand-alone therapy, he said, stressing the importance of also using nonpharmacologic therapies in patients with centralized pain.

The nonpharmacologic options are similar for any chronic pain state, Dr. Clauw said, noting that strong evidence exists for education, aerobic exercise, and cognitive-behavior therapy. Modest evidence exists for strength training, hypnotherapy, biofeedback, balneotherapy, yoga, and tai chi. Weak evidence suggests a possible benefit with acupuncture, chiropractic therapy, manual and massage therapy, electrotherapy, and ultrasound. No evidence exists for trigger point injections and flexibility exercise.

Many of the particularly useful nonpharmacologic therapies, including cognitive-behavior therapy or exercise, are rarely used in clinical practice, he noted.

An approach known as the ExPRESS approach to chronic pain can help improve outcomes by addressing the various factors involved in centralized pain. ExPRESS stands for exercise, psychiatric comorbidity, regaining function, education, sleep hygiene, and stress management, he said.

The approach was proposed by Afton L. Hassett, Psy.D., and Richard N. Gevirtz, Ph.D., in a 2009 study (Rheum. Dis. Clin. North Am. 2009;35:393-407), which stresses the importance of providing comprehensive care for patients with chronic pain by addressing each of these interrelated factors.

It doesn’t matter where the pain is coming from. Long-term pain increases stress levels, decreases sleep and exercise, and can lead to social isolation – all things that can make pain worse. Thus, a change in the "volume control" of the central nervous system isn’t necessarily to blame when a patient experiences worsening over time, rather it may be the accumulation of these other factors, he said at the meeting held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

"Unless and until you treat these patients with exercise, education, and cognitive-behavioral therapy ... you’re not going to make chronic pain patients better, and you’re certainly not going to make centralized pain patients better unless you aggressively use [these tools]," he said.

Dr. Clauw has been a consultant for Merck, UCB, Cypress Biosciences, Eli Lilly, Jazz Pharmaceuticals, Pierre Fabre Pharmaceuticals, Pfizer, Nuvo Research, and Forest Laboratories, and has received grant support from Nuvo Research and Forest Laboratories.

LAS VEGAS – Centralized pain or sensitization occurs in most patients with fibromyalgia and can be identified in 20%-30% of patients with other pain states, such as rheumatoid arthritis, lupus, low back pain, and osteoarthritis, according to Dr. Daniel J. Clauw.

This has implications for both diagnosis and treatment of these conditions. However, current paradigms for diagnosis and treatment are antiquated, Dr. Clauw, professor of anesthesiology and medicine, and director of the chronic pain and fatigue research center at the University of Michigan, Ann Arbor, said at the annual Perspectives in Rheumatic Diseases conference.

There is no chronic pain state in which the degree of damage or inflammation in the periphery correlates well with the level of pain the patient experiences, and yet, existing diagnostic paradigms – as well as the terms used to describe chronic pain states – imply otherwise, he explained.

In fact, until recently it was typically assumed that when a disparity between peripheral findings and pain existed, the problem was a psychological one, he said.

In reality, there are numerous nonpsychological neurobiologic factors that affect pain sensitivity, and these are operative in many chronic pain states. Thus, it is imperative that the diagnostic and therapeutic paradigms be modified to better identify and treat "central pain," he said.

Centralized pain is pain in which the spinal cord and/or brain play a much bigger role than the peripheral nervous system. In patients with centralized pain, the pain is more associated with pain processing pathways than with "peripheral nociceptive input out at the periphery that you will make better with nonsteroidal anti-inflammatory drugs, opioids, and surgical procedures," Dr. Clauw said.

"The problem is the diseases don’t tell us which pain state someone has," he added.

Certain clinical characteristics can provide clues, however. Among them are multifocal pain, use of neuropathic verbal descriptors of pain, higher current and lifetime history of pain, the presence of multiple other somatic symptoms, and sensitivity to multiple sensory stimuli.

"When someone centralizes their pain, they don’t have just pain any more, they have a lot of other central nervous system symptoms that are also coming from the brain, including fatigue, memory problems, sleep disturbances," he said, noting that when a patient presents with multifocal pain accompanied by these other symptoms, this should be "a blinking neon light that this person has centralized their pain."

Additionally, patients with centralized pain have a wide continuum of pain, may experience exacerbation because of stressors, and may have a generally normal physical examination except for diffuse tenderness and nonspecific neurologic signs. This type of pain is 1.5 to 2 times more common in women than men and has strong genetic underpinnings, so a family history can be helpful in identifying patients with centralized pain, Dr. Clauw noted.

Studies suggest that a number of genes that may be involved in the process, including the gene encoding catecholamine-O-methyltransferase (COMT), certain alleles of which are associated with a threefold increased risk of developing different types of chronic pain conditions, he said.

A number of pharmacologic agents have been studied for central pain; the strongest evidence exists for dual reuptake inhibitors (including tricyclic compounds, selective-norepinephrine reuptake inhibitors, and norepinephrine-selective reuptake inhibitors), and the anticonvulsants gabapentin and pregabalin. Modest evidence exists for tramadol, older less-selective selective-serotonin reuptake inhibitors, gamma-hydroxybutyrate, and low-dose naltrexone. Weak evidence suggests a benefit with cannabinoids (although evidence of benefit is increasing), growth hormone, 5-hydroxytryptamine, tropisetron, S-adenosyl-L-methionine. There is no evidence with respect to opioids, corticosteroids, nonsteroidal antiinflammatory drugs, benzodiazepine and nonbenzodiazepine hypnotics, and guaifenesin.

None of the available pharmacologic agents have anything more than modest efficacy when used as stand-alone therapy, he said, stressing the importance of also using nonpharmacologic therapies in patients with centralized pain.

The nonpharmacologic options are similar for any chronic pain state, Dr. Clauw said, noting that strong evidence exists for education, aerobic exercise, and cognitive-behavior therapy. Modest evidence exists for strength training, hypnotherapy, biofeedback, balneotherapy, yoga, and tai chi. Weak evidence suggests a possible benefit with acupuncture, chiropractic therapy, manual and massage therapy, electrotherapy, and ultrasound. No evidence exists for trigger point injections and flexibility exercise.

Many of the particularly useful nonpharmacologic therapies, including cognitive-behavior therapy or exercise, are rarely used in clinical practice, he noted.

An approach known as the ExPRESS approach to chronic pain can help improve outcomes by addressing the various factors involved in centralized pain. ExPRESS stands for exercise, psychiatric comorbidity, regaining function, education, sleep hygiene, and stress management, he said.

The approach was proposed by Afton L. Hassett, Psy.D., and Richard N. Gevirtz, Ph.D., in a 2009 study (Rheum. Dis. Clin. North Am. 2009;35:393-407), which stresses the importance of providing comprehensive care for patients with chronic pain by addressing each of these interrelated factors.

It doesn’t matter where the pain is coming from. Long-term pain increases stress levels, decreases sleep and exercise, and can lead to social isolation – all things that can make pain worse. Thus, a change in the "volume control" of the central nervous system isn’t necessarily to blame when a patient experiences worsening over time, rather it may be the accumulation of these other factors, he said at the meeting held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

"Unless and until you treat these patients with exercise, education, and cognitive-behavioral therapy ... you’re not going to make chronic pain patients better, and you’re certainly not going to make centralized pain patients better unless you aggressively use [these tools]," he said.

Dr. Clauw has been a consultant for Merck, UCB, Cypress Biosciences, Eli Lilly, Jazz Pharmaceuticals, Pierre Fabre Pharmaceuticals, Pfizer, Nuvo Research, and Forest Laboratories, and has received grant support from Nuvo Research and Forest Laboratories.

LAS VEGAS – The use of an alternative anti–tumor necrosis factor drug is not necessarily precluded in a psoriasis patient with both skin and joint symptoms who has failed two previous anti-TNF drugs, according to Dr. Kenneth B. Gordon.

Dr. Gordon, professor of dermatology at Northwestern University, Chicago, described a case involving a 52-year-old man with a 20-year history of psoriasis who initially presented with mainly scalp and limited plaque psoriasis, and who was treated with topical corticosteroids and topical calcipotriene. After developing more extensive disease, he was treated successfully with ultraviolet B phototherapy.

Eleven years after first presenting with psoriasis, he presented with peripheral arthritis and enthesitis and was diagnosed with psoriatic arthritis.

The patient was treated initially with sulfasalazine, but failed to respond; methotrexate had only modest benefit, and at higher doses the patient developed liver function test abnormalities due to steatohepatitis, Dr. Gordon said at Perspectives in Rheumatic Diseases 2013.

Etanercept was initiated at 50 mg twice weekly, and the patient had an excellent initial response.

However, after stepping down to 50 mg weekly, his psoriasis flared.

"His joints were doing fine, but his skin was getting bad," Dr. Gordon said, noting that this type of response was also seen in early studies of etanercept, which showed that when doses were reduced to 50 mg weekly after 12 weeks, responses leveled off, with some patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) 75 response, and some losing PASI 75 response.

"It turns out that this occurs in 20%-30% of patients," he said, adding that some controversy exists regarding dosing, because "it’s not entirely clear that if you had just started at the lower dose and just let them go at the 50 mg once a week, that at 6 months they’d be any different than if you gave them the higher dose initially."

The REVEAL study of adalimumab for psoriasis also demonstrated loss of response after 33 weeks among those with an initial PASI 75 response (J. Am. Acad. Dermatol. 2012;66:241-51), he said.

"So clearly, patients lose response. Now, that lessens over time, but in the first year in psoriasis – and my guess is, in psoriatic arthritis as well – you have loss of effect at a relatively high level with all of these medicines," he said.

In fact, in the patient Dr. Gordon presented, a switch to adalimumab at a dose of 40 mg every other week resulted in an excellent initial response in both joints and skin, but skin symptoms returned after 8 months.

"This is something we’re all familiar with – patients doing well on an anti-TNF and then losing effect after a period of time on medication," he said.

So what are the alternatives?

An anti-TNF drug option after the patient cycles through etanercept, adalimumab, and infliximab is certolizumab, which was approved in September for the treatment of psoriatic arthritis. Study data suggest that the drug is "quite effective for psoriasis, was well tolerated, and similar to the other anti-TNFs," he said.

Using certolizumab is a reasonable approach that appears to work for both skin and joint symptoms, he said.

Golimumab is another possible option for treatment, but primary psoriasis data are lacking with this drug.

"It is my feeling that golimumab is probably not as potent for psoriasis as the other anti-TNF agents that we have, but that is an opinion," he said.

As for alternatives to anti-TNF agents, the PHEONIX 2 trial (Lancet 2008;371:1675-84) provided reasonable data in support of the interleukin-12 and -23 monoclonal antibody ustekinumab for skin disease, but patients who failed prior anti-TNF therapy actually had a poorer outcome, so that is something to keep in mind, he said, noting that adding methotrexate may help prevent a flare in patients who are switched from an anti-TNF agent to ustekinumab.

Ustekinumab, which also was approved in September for the treatment of psoriatic arthritis, is likely more useful for the skin, but is not exceptional for joint disease, he said at the meeting, held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Apremilast and tofacitinib, drugs now in development for psoriasis, may also prove useful in the future, as they may "theoretically be of benefit" based on currently available data, he said.

Dr. Gordon has received research support and/or honoraria from AbbVie (which markets adalimumab), Amgen (which markets etanercept), Celgene (which is developing apremilast), Eli Lilly, Janssen (which markets golimumab, infliximab, and ustekinumab), Novartis, and Pfizer (which markets tofacitinib).

LAS VEGAS – The use of an alternative anti–tumor necrosis factor drug is not necessarily precluded in a psoriasis patient with both skin and joint symptoms who has failed two previous anti-TNF drugs, according to Dr. Kenneth B. Gordon.

Dr. Gordon, professor of dermatology at Northwestern University, Chicago, described a case involving a 52-year-old man with a 20-year history of psoriasis who initially presented with mainly scalp and limited plaque psoriasis, and who was treated with topical corticosteroids and topical calcipotriene. After developing more extensive disease, he was treated successfully with ultraviolet B phototherapy.

Eleven years after first presenting with psoriasis, he presented with peripheral arthritis and enthesitis and was diagnosed with psoriatic arthritis.

The patient was treated initially with sulfasalazine, but failed to respond; methotrexate had only modest benefit, and at higher doses the patient developed liver function test abnormalities due to steatohepatitis, Dr. Gordon said at Perspectives in Rheumatic Diseases 2013.

Etanercept was initiated at 50 mg twice weekly, and the patient had an excellent initial response.

However, after stepping down to 50 mg weekly, his psoriasis flared.

"His joints were doing fine, but his skin was getting bad," Dr. Gordon said, noting that this type of response was also seen in early studies of etanercept, which showed that when doses were reduced to 50 mg weekly after 12 weeks, responses leveled off, with some patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) 75 response, and some losing PASI 75 response.

"It turns out that this occurs in 20%-30% of patients," he said, adding that some controversy exists regarding dosing, because "it’s not entirely clear that if you had just started at the lower dose and just let them go at the 50 mg once a week, that at 6 months they’d be any different than if you gave them the higher dose initially."

The REVEAL study of adalimumab for psoriasis also demonstrated loss of response after 33 weeks among those with an initial PASI 75 response (J. Am. Acad. Dermatol. 2012;66:241-51), he said.

"So clearly, patients lose response. Now, that lessens over time, but in the first year in psoriasis – and my guess is, in psoriatic arthritis as well – you have loss of effect at a relatively high level with all of these medicines," he said.

In fact, in the patient Dr. Gordon presented, a switch to adalimumab at a dose of 40 mg every other week resulted in an excellent initial response in both joints and skin, but skin symptoms returned after 8 months.

"This is something we’re all familiar with – patients doing well on an anti-TNF and then losing effect after a period of time on medication," he said.

So what are the alternatives?

An anti-TNF drug option after the patient cycles through etanercept, adalimumab, and infliximab is certolizumab, which was approved in September for the treatment of psoriatic arthritis. Study data suggest that the drug is "quite effective for psoriasis, was well tolerated, and similar to the other anti-TNFs," he said.

Using certolizumab is a reasonable approach that appears to work for both skin and joint symptoms, he said.

Golimumab is another possible option for treatment, but primary psoriasis data are lacking with this drug.

"It is my feeling that golimumab is probably not as potent for psoriasis as the other anti-TNF agents that we have, but that is an opinion," he said.

As for alternatives to anti-TNF agents, the PHEONIX 2 trial (Lancet 2008;371:1675-84) provided reasonable data in support of the interleukin-12 and -23 monoclonal antibody ustekinumab for skin disease, but patients who failed prior anti-TNF therapy actually had a poorer outcome, so that is something to keep in mind, he said, noting that adding methotrexate may help prevent a flare in patients who are switched from an anti-TNF agent to ustekinumab.

Ustekinumab, which also was approved in September for the treatment of psoriatic arthritis, is likely more useful for the skin, but is not exceptional for joint disease, he said at the meeting, held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Apremilast and tofacitinib, drugs now in development for psoriasis, may also prove useful in the future, as they may "theoretically be of benefit" based on currently available data, he said.

Dr. Gordon has received research support and/or honoraria from AbbVie (which markets adalimumab), Amgen (which markets etanercept), Celgene (which is developing apremilast), Eli Lilly, Janssen (which markets golimumab, infliximab, and ustekinumab), Novartis, and Pfizer (which markets tofacitinib).

LAS VEGAS – The use of an alternative anti–tumor necrosis factor drug is not necessarily precluded in a psoriasis patient with both skin and joint symptoms who has failed two previous anti-TNF drugs, according to Dr. Kenneth B. Gordon.

Dr. Gordon, professor of dermatology at Northwestern University, Chicago, described a case involving a 52-year-old man with a 20-year history of psoriasis who initially presented with mainly scalp and limited plaque psoriasis, and who was treated with topical corticosteroids and topical calcipotriene. After developing more extensive disease, he was treated successfully with ultraviolet B phototherapy.

Eleven years after first presenting with psoriasis, he presented with peripheral arthritis and enthesitis and was diagnosed with psoriatic arthritis.

The patient was treated initially with sulfasalazine, but failed to respond; methotrexate had only modest benefit, and at higher doses the patient developed liver function test abnormalities due to steatohepatitis, Dr. Gordon said at Perspectives in Rheumatic Diseases 2013.

Etanercept was initiated at 50 mg twice weekly, and the patient had an excellent initial response.

However, after stepping down to 50 mg weekly, his psoriasis flared.

"His joints were doing fine, but his skin was getting bad," Dr. Gordon said, noting that this type of response was also seen in early studies of etanercept, which showed that when doses were reduced to 50 mg weekly after 12 weeks, responses leveled off, with some patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI) 75 response, and some losing PASI 75 response.

"It turns out that this occurs in 20%-30% of patients," he said, adding that some controversy exists regarding dosing, because "it’s not entirely clear that if you had just started at the lower dose and just let them go at the 50 mg once a week, that at 6 months they’d be any different than if you gave them the higher dose initially."

The REVEAL study of adalimumab for psoriasis also demonstrated loss of response after 33 weeks among those with an initial PASI 75 response (J. Am. Acad. Dermatol. 2012;66:241-51), he said.

"So clearly, patients lose response. Now, that lessens over time, but in the first year in psoriasis – and my guess is, in psoriatic arthritis as well – you have loss of effect at a relatively high level with all of these medicines," he said.

In fact, in the patient Dr. Gordon presented, a switch to adalimumab at a dose of 40 mg every other week resulted in an excellent initial response in both joints and skin, but skin symptoms returned after 8 months.

"This is something we’re all familiar with – patients doing well on an anti-TNF and then losing effect after a period of time on medication," he said.

So what are the alternatives?

An anti-TNF drug option after the patient cycles through etanercept, adalimumab, and infliximab is certolizumab, which was approved in September for the treatment of psoriatic arthritis. Study data suggest that the drug is "quite effective for psoriasis, was well tolerated, and similar to the other anti-TNFs," he said.

Using certolizumab is a reasonable approach that appears to work for both skin and joint symptoms, he said.

Golimumab is another possible option for treatment, but primary psoriasis data are lacking with this drug.

"It is my feeling that golimumab is probably not as potent for psoriasis as the other anti-TNF agents that we have, but that is an opinion," he said.

As for alternatives to anti-TNF agents, the PHEONIX 2 trial (Lancet 2008;371:1675-84) provided reasonable data in support of the interleukin-12 and -23 monoclonal antibody ustekinumab for skin disease, but patients who failed prior anti-TNF therapy actually had a poorer outcome, so that is something to keep in mind, he said, noting that adding methotrexate may help prevent a flare in patients who are switched from an anti-TNF agent to ustekinumab.

Ustekinumab, which also was approved in September for the treatment of psoriatic arthritis, is likely more useful for the skin, but is not exceptional for joint disease, he said at the meeting, held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Apremilast and tofacitinib, drugs now in development for psoriasis, may also prove useful in the future, as they may "theoretically be of benefit" based on currently available data, he said.

Dr. Gordon has received research support and/or honoraria from AbbVie (which markets adalimumab), Amgen (which markets etanercept), Celgene (which is developing apremilast), Eli Lilly, Janssen (which markets golimumab, infliximab, and ustekinumab), Novartis, and Pfizer (which markets tofacitinib).

LAS VEGAS – Scleroderma patients are at particularly high risk for developing pulmonary arterial hypertension, but treatment options are expanding, and with early referral to a PAH specialist, outcomes can be improved, according to Dr. Ronald J. Oudiz.

"In 1995 we had nothing. Now we have nine treatments specifically for PAH, and more that are being looked at," he said at Perspectives in Rheumatic Diseases 2013.

Three major signaling pathways, including the prostacyclin, endothelin, and nitric oxide pathways, form the basis for the available treatment options for this progressive and deadly disease, which has a 36-month survival rate of only about 60%. The treatments include prostacyclin analogues, endothelin receptor antagonists, and phosphodiesterase type 5 (PDE-5) inhibitors, said Dr. Oudiz, professor of medicine at the University of California, Los Angeles, and director of the Liu Center for Pulmonary Hypertension at Harbor-UCLA Medical Center.

The prostacyclin analogues include intravenous epoprostenol, inhaled iloprost, and treprostinil, which can be inhaled or delivered intravenously or subcutaneously. These have been shown to improve performance on the 6-minute walk test in a dose-dependent fashion, Dr. Oudiz noted.

Side effects with prostacyclin analogues can include flushing, headache, rash, thrombocytopenia, infection, and gastrointestinal effects such as diarrhea, nausea, and weight loss.

The endothelin receptor antagonists include bosentan and ambrisentan, which both are delivered orally. Their approval was "revolutionary, because for a while we only had IV drugs," he said.

Side effects with endothelin receptor antagonists include liver function test abnormalities, headache, nasal congestion, and edema. Although these drugs are generally tolerated well, liver function test abnormalities and edema can be troublesome for both patients and physicians as they require close monitoring and dose modification or interruption, he said.

PDE-5 inhibitors include sildenafil and tadalafil, which also are both oral drugs, and which have side effects that are similar to those seen with the endothelin-receptor antagonists, with the addition of myalgia, diarrhea, dyspepsia, and nose bleeds, he noted.

Overall, studies suggest that treatment with PAH drugs not only leads to improved exercise capacity, but probably improves long-term survival. In a meta-analysis of several major PAH drug trials, the majority of studies showed a potential mortality benefit (Eur. Heart. J. 2009;30:394-403), Dr. Oudiz noted.

"I say potential because we know none of the studies assessed in the meta-analysis were powered to examine mortality ... but nevertheless, we believe we’re doing more than just improving exercise capacity," he said.

In fact, in a study published in August in the New England Journal of Medicine, the new endothelin receptor antagonist macitentan was associated with a dose-dependent decrease in the number of outcome events measured, relative to placebo, including death, transplant, and heart failure in patients with PAH, he noted (N. Engl. J. Med. 2013;369:809-18).

"These are some really important endpoints we’re finally starting to meet," he said.

These advances underscore the importance of increased awareness of the risk of PAH in scleroderma and early recognition of the condition, and – since diagnosis and the subtleties of management are complex – they also underscore the importance of early referral to a PAH specialist, he said.

"Early treatment is always preferable to later treatment," he concluded at the meeting held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Oudiz has received grant or research support from, served as a consultant to, and/or served on a speakers’ bureau for Actelion, Bayer, Gilead, Ikaria, Lung, Pfizer, and United Therapeutics.

LAS VEGAS – Scleroderma patients are at particularly high risk for developing pulmonary arterial hypertension, but treatment options are expanding, and with early referral to a PAH specialist, outcomes can be improved, according to Dr. Ronald J. Oudiz.

"In 1995 we had nothing. Now we have nine treatments specifically for PAH, and more that are being looked at," he said at Perspectives in Rheumatic Diseases 2013.

Three major signaling pathways, including the prostacyclin, endothelin, and nitric oxide pathways, form the basis for the available treatment options for this progressive and deadly disease, which has a 36-month survival rate of only about 60%. The treatments include prostacyclin analogues, endothelin receptor antagonists, and phosphodiesterase type 5 (PDE-5) inhibitors, said Dr. Oudiz, professor of medicine at the University of California, Los Angeles, and director of the Liu Center for Pulmonary Hypertension at Harbor-UCLA Medical Center.

The prostacyclin analogues include intravenous epoprostenol, inhaled iloprost, and treprostinil, which can be inhaled or delivered intravenously or subcutaneously. These have been shown to improve performance on the 6-minute walk test in a dose-dependent fashion, Dr. Oudiz noted.

Side effects with prostacyclin analogues can include flushing, headache, rash, thrombocytopenia, infection, and gastrointestinal effects such as diarrhea, nausea, and weight loss.

The endothelin receptor antagonists include bosentan and ambrisentan, which both are delivered orally. Their approval was "revolutionary, because for a while we only had IV drugs," he said.

Side effects with endothelin receptor antagonists include liver function test abnormalities, headache, nasal congestion, and edema. Although these drugs are generally tolerated well, liver function test abnormalities and edema can be troublesome for both patients and physicians as they require close monitoring and dose modification or interruption, he said.

PDE-5 inhibitors include sildenafil and tadalafil, which also are both oral drugs, and which have side effects that are similar to those seen with the endothelin-receptor antagonists, with the addition of myalgia, diarrhea, dyspepsia, and nose bleeds, he noted.

Overall, studies suggest that treatment with PAH drugs not only leads to improved exercise capacity, but probably improves long-term survival. In a meta-analysis of several major PAH drug trials, the majority of studies showed a potential mortality benefit (Eur. Heart. J. 2009;30:394-403), Dr. Oudiz noted.

"I say potential because we know none of the studies assessed in the meta-analysis were powered to examine mortality ... but nevertheless, we believe we’re doing more than just improving exercise capacity," he said.

In fact, in a study published in August in the New England Journal of Medicine, the new endothelin receptor antagonist macitentan was associated with a dose-dependent decrease in the number of outcome events measured, relative to placebo, including death, transplant, and heart failure in patients with PAH, he noted (N. Engl. J. Med. 2013;369:809-18).

"These are some really important endpoints we’re finally starting to meet," he said.

These advances underscore the importance of increased awareness of the risk of PAH in scleroderma and early recognition of the condition, and – since diagnosis and the subtleties of management are complex – they also underscore the importance of early referral to a PAH specialist, he said.

"Early treatment is always preferable to later treatment," he concluded at the meeting held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Oudiz has received grant or research support from, served as a consultant to, and/or served on a speakers’ bureau for Actelion, Bayer, Gilead, Ikaria, Lung, Pfizer, and United Therapeutics.

LAS VEGAS – Scleroderma patients are at particularly high risk for developing pulmonary arterial hypertension, but treatment options are expanding, and with early referral to a PAH specialist, outcomes can be improved, according to Dr. Ronald J. Oudiz.

"In 1995 we had nothing. Now we have nine treatments specifically for PAH, and more that are being looked at," he said at Perspectives in Rheumatic Diseases 2013.

Three major signaling pathways, including the prostacyclin, endothelin, and nitric oxide pathways, form the basis for the available treatment options for this progressive and deadly disease, which has a 36-month survival rate of only about 60%. The treatments include prostacyclin analogues, endothelin receptor antagonists, and phosphodiesterase type 5 (PDE-5) inhibitors, said Dr. Oudiz, professor of medicine at the University of California, Los Angeles, and director of the Liu Center for Pulmonary Hypertension at Harbor-UCLA Medical Center.

The prostacyclin analogues include intravenous epoprostenol, inhaled iloprost, and treprostinil, which can be inhaled or delivered intravenously or subcutaneously. These have been shown to improve performance on the 6-minute walk test in a dose-dependent fashion, Dr. Oudiz noted.

Side effects with prostacyclin analogues can include flushing, headache, rash, thrombocytopenia, infection, and gastrointestinal effects such as diarrhea, nausea, and weight loss.

The endothelin receptor antagonists include bosentan and ambrisentan, which both are delivered orally. Their approval was "revolutionary, because for a while we only had IV drugs," he said.

Side effects with endothelin receptor antagonists include liver function test abnormalities, headache, nasal congestion, and edema. Although these drugs are generally tolerated well, liver function test abnormalities and edema can be troublesome for both patients and physicians as they require close monitoring and dose modification or interruption, he said.

PDE-5 inhibitors include sildenafil and tadalafil, which also are both oral drugs, and which have side effects that are similar to those seen with the endothelin-receptor antagonists, with the addition of myalgia, diarrhea, dyspepsia, and nose bleeds, he noted.

Overall, studies suggest that treatment with PAH drugs not only leads to improved exercise capacity, but probably improves long-term survival. In a meta-analysis of several major PAH drug trials, the majority of studies showed a potential mortality benefit (Eur. Heart. J. 2009;30:394-403), Dr. Oudiz noted.

"I say potential because we know none of the studies assessed in the meta-analysis were powered to examine mortality ... but nevertheless, we believe we’re doing more than just improving exercise capacity," he said.

In fact, in a study published in August in the New England Journal of Medicine, the new endothelin receptor antagonist macitentan was associated with a dose-dependent decrease in the number of outcome events measured, relative to placebo, including death, transplant, and heart failure in patients with PAH, he noted (N. Engl. J. Med. 2013;369:809-18).

"These are some really important endpoints we’re finally starting to meet," he said.

These advances underscore the importance of increased awareness of the risk of PAH in scleroderma and early recognition of the condition, and – since diagnosis and the subtleties of management are complex – they also underscore the importance of early referral to a PAH specialist, he said.

"Early treatment is always preferable to later treatment," he concluded at the meeting held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Oudiz has received grant or research support from, served as a consultant to, and/or served on a speakers’ bureau for Actelion, Bayer, Gilead, Ikaria, Lung, Pfizer, and United Therapeutics.

LAS VEGAS – Patients recall only about 10% of the information imparted by physicians during an office visit, and about half of all patients don’t understand their treatment plan, according to Richard Nordstrom.

Furthermore, 90% of patients have difficulty following routine medical advice, said Mr. Nordstrom, chief executive officer for a health care communications consulting firm in Montclair, N.J.

The problem isn’t just one of low health care literacy. Patients who receive a significant, life-altering diagnosis often don’t hear much else after they hear words like, "you have rheumatoid arthritis," he said at Perspectives in Rheumatic Diseases 2013.

This is true regardless of a patient’s literacy level, and even those with high literacy may be too embarrassed to ask questions that they think might make them sound uninformed, he noted.

These factors lead to poor outcomes and less patient satisfaction. Improved communication can go a long way toward improving both, he said.

Physicians have so little time with patients; about half of those in a recent survey said that they see between 50 and 100 patients each week. The average time a health care professional spends educating a patient on conditions and treatments critical for the patient’s care is only 11 minutes, and during that time, patients ask an average of only two questions.

"Your moments with that patient are critical," Mr. Nordstrom said, stressing that for the patient, that time is the most valuable time they will spend "in their entire health care ecosystem."

Excellent communication in those brief moments will ensure that the most is made of that time, and that the patient experience is exceptional. Several steps can be taken to improve communication and to enhance the doctor-patient relationship – and to improve satisfaction and outcomes.

For one thing, talk more slowly, he said.

Eleven minutes is not a lot of time, and while slowing down may seem counterproductive, it will allow more information to sink in.

Also, use plain language. "NSAID" may seem like plain language to you, but for a patient, "anti-inflammatory" will likely make more sense. Remember that what may seem like plain language often is jargon.

"One report suggested that if you spend time on an educational intervention on something as simple as an NSAID, you’ll have a fourfold increase in efficacy in pain relief and reduction of inflammation," he said. "Assuming patients understand what they’re supposed to do is not enough."

Visual tools – pictures and "infographics" – are very helpful for improving communication and information retention among patients, as well.

Physicians often scribble information and drawings on the white examination table paper, then crumple that up and throw it away – and patients often fish that out of the trash can and take it home, he said, in explaining the value of visual learning.

"Infographics provide visual ways to communicate a lot of data," he said.

Technology, such as tablet computers, which are increasingly used in the office setting, can assist with this and can be an excellent communication tool rather than just a research tool and a tool for recording patient data.

Other tips for improving communication include using short- rather than long-form information and creating an empathic environment that makes patients feel comfortable asking questions.

Brief communications are important. Many patients get lost trying to navigate through long-form communications. It is important to filter it down to simple, small bits of information, Mr. Nordstrom said.

In addition to improving outcomes and patient satisfaction, improving communication is likely to reduce your risk of being sued for malpractice. One report suggests that at the core of 75% of malpractice cases are one or more of six factors: an inadequate explanation of the diagnosis, an inadequate explanation of the treatment, a feeling on the part of the patient of being ignored, a failure by the physician to understand the perspective of the patient or family/caregiver, a sense on the part of the patient that his or her views are devalued, and a sense by the patient that he or she was rushed.

Conversely, when communication is used to promote a more patient-centered relationship, which Mr. Nordstrom called an "exceptional patient experience," patients tend to come away feeling more engaged, activated, and empowered, he said at the meeting, which was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Mr. Nordstrom reported having no relevant financial disclosures.

LAS VEGAS – Patients recall only about 10% of the information imparted by physicians during an office visit, and about half of all patients don’t understand their treatment plan, according to Richard Nordstrom.

Furthermore, 90% of patients have difficulty following routine medical advice, said Mr. Nordstrom, chief executive officer for a health care communications consulting firm in Montclair, N.J.

The problem isn’t just one of low health care literacy. Patients who receive a significant, life-altering diagnosis often don’t hear much else after they hear words like, "you have rheumatoid arthritis," he said at Perspectives in Rheumatic Diseases 2013.

This is true regardless of a patient’s literacy level, and even those with high literacy may be too embarrassed to ask questions that they think might make them sound uninformed, he noted.

These factors lead to poor outcomes and less patient satisfaction. Improved communication can go a long way toward improving both, he said.

Physicians have so little time with patients; about half of those in a recent survey said that they see between 50 and 100 patients each week. The average time a health care professional spends educating a patient on conditions and treatments critical for the patient’s care is only 11 minutes, and during that time, patients ask an average of only two questions.

"Your moments with that patient are critical," Mr. Nordstrom said, stressing that for the patient, that time is the most valuable time they will spend "in their entire health care ecosystem."

Excellent communication in those brief moments will ensure that the most is made of that time, and that the patient experience is exceptional. Several steps can be taken to improve communication and to enhance the doctor-patient relationship – and to improve satisfaction and outcomes.

For one thing, talk more slowly, he said.

Eleven minutes is not a lot of time, and while slowing down may seem counterproductive, it will allow more information to sink in.

Also, use plain language. "NSAID" may seem like plain language to you, but for a patient, "anti-inflammatory" will likely make more sense. Remember that what may seem like plain language often is jargon.

"One report suggested that if you spend time on an educational intervention on something as simple as an NSAID, you’ll have a fourfold increase in efficacy in pain relief and reduction of inflammation," he said. "Assuming patients understand what they’re supposed to do is not enough."

Visual tools – pictures and "infographics" – are very helpful for improving communication and information retention among patients, as well.

Physicians often scribble information and drawings on the white examination table paper, then crumple that up and throw it away – and patients often fish that out of the trash can and take it home, he said, in explaining the value of visual learning.

"Infographics provide visual ways to communicate a lot of data," he said.

Technology, such as tablet computers, which are increasingly used in the office setting, can assist with this and can be an excellent communication tool rather than just a research tool and a tool for recording patient data.

Other tips for improving communication include using short- rather than long-form information and creating an empathic environment that makes patients feel comfortable asking questions.

Brief communications are important. Many patients get lost trying to navigate through long-form communications. It is important to filter it down to simple, small bits of information, Mr. Nordstrom said.

In addition to improving outcomes and patient satisfaction, improving communication is likely to reduce your risk of being sued for malpractice. One report suggests that at the core of 75% of malpractice cases are one or more of six factors: an inadequate explanation of the diagnosis, an inadequate explanation of the treatment, a feeling on the part of the patient of being ignored, a failure by the physician to understand the perspective of the patient or family/caregiver, a sense on the part of the patient that his or her views are devalued, and a sense by the patient that he or she was rushed.

Conversely, when communication is used to promote a more patient-centered relationship, which Mr. Nordstrom called an "exceptional patient experience," patients tend to come away feeling more engaged, activated, and empowered, he said at the meeting, which was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Mr. Nordstrom reported having no relevant financial disclosures.

LAS VEGAS – Patients recall only about 10% of the information imparted by physicians during an office visit, and about half of all patients don’t understand their treatment plan, according to Richard Nordstrom.

Furthermore, 90% of patients have difficulty following routine medical advice, said Mr. Nordstrom, chief executive officer for a health care communications consulting firm in Montclair, N.J.

The problem isn’t just one of low health care literacy. Patients who receive a significant, life-altering diagnosis often don’t hear much else after they hear words like, "you have rheumatoid arthritis," he said at Perspectives in Rheumatic Diseases 2013.

This is true regardless of a patient’s literacy level, and even those with high literacy may be too embarrassed to ask questions that they think might make them sound uninformed, he noted.

These factors lead to poor outcomes and less patient satisfaction. Improved communication can go a long way toward improving both, he said.

Physicians have so little time with patients; about half of those in a recent survey said that they see between 50 and 100 patients each week. The average time a health care professional spends educating a patient on conditions and treatments critical for the patient’s care is only 11 minutes, and during that time, patients ask an average of only two questions.

"Your moments with that patient are critical," Mr. Nordstrom said, stressing that for the patient, that time is the most valuable time they will spend "in their entire health care ecosystem."

Excellent communication in those brief moments will ensure that the most is made of that time, and that the patient experience is exceptional. Several steps can be taken to improve communication and to enhance the doctor-patient relationship – and to improve satisfaction and outcomes.

For one thing, talk more slowly, he said.

Eleven minutes is not a lot of time, and while slowing down may seem counterproductive, it will allow more information to sink in.

Also, use plain language. "NSAID" may seem like plain language to you, but for a patient, "anti-inflammatory" will likely make more sense. Remember that what may seem like plain language often is jargon.

"One report suggested that if you spend time on an educational intervention on something as simple as an NSAID, you’ll have a fourfold increase in efficacy in pain relief and reduction of inflammation," he said. "Assuming patients understand what they’re supposed to do is not enough."

Visual tools – pictures and "infographics" – are very helpful for improving communication and information retention among patients, as well.

Physicians often scribble information and drawings on the white examination table paper, then crumple that up and throw it away – and patients often fish that out of the trash can and take it home, he said, in explaining the value of visual learning.

"Infographics provide visual ways to communicate a lot of data," he said.

Technology, such as tablet computers, which are increasingly used in the office setting, can assist with this and can be an excellent communication tool rather than just a research tool and a tool for recording patient data.

Other tips for improving communication include using short- rather than long-form information and creating an empathic environment that makes patients feel comfortable asking questions.

Brief communications are important. Many patients get lost trying to navigate through long-form communications. It is important to filter it down to simple, small bits of information, Mr. Nordstrom said.

In addition to improving outcomes and patient satisfaction, improving communication is likely to reduce your risk of being sued for malpractice. One report suggests that at the core of 75% of malpractice cases are one or more of six factors: an inadequate explanation of the diagnosis, an inadequate explanation of the treatment, a feeling on the part of the patient of being ignored, a failure by the physician to understand the perspective of the patient or family/caregiver, a sense on the part of the patient that his or her views are devalued, and a sense by the patient that he or she was rushed.

Conversely, when communication is used to promote a more patient-centered relationship, which Mr. Nordstrom called an "exceptional patient experience," patients tend to come away feeling more engaged, activated, and empowered, he said at the meeting, which was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Mr. Nordstrom reported having no relevant financial disclosures.

LAS VEGAS – Concerns about use of a tumor necrosis factor inhibitor in a rheumatoid arthritis patient with a history of cancer are common, but the data are largely reassuring, according to Dr. Iain McInnes.

He used as an example a case involving a 56-year-old woman who had erosive RA that was anti-citrullinated peptide antibody–positive (ACPA+). The woman failed triple therapy, responded well to etanercept, and achieved clinical remission after 9 months. The patient then developed breast cancer and her TNF inhibitor was stopped, as recommended by current American College of Rheumatology guidelines.

The patient returned a year later after undergoing "the whole gamut from the oncological armamentarium," including chemotherapy, radiation therapy, and surgery.

"So what do you do? She wants her TNF blocker back – she did very well on it," said Dr. McInnes, who is Muirhead Chair of Medicine and Director of Institute of Infection, Immunity, and Inflammation at the University of Glasgow, Scotland.

Prescribe a conventional disease-modifying antirheumatic drug (DMARD)? Try a different mode of action?

What if the patient is a 56-year-old female with ACPA+ erosive RA who failed triple therapy and leflunomide; is doing poorly; has a history of breast cancer treated successfully 3 years ago by lumpectomy, radiation therapy and chemotherapy; and asks for a change in therapy?

According to the ACR guidelines, any biologic agent can be used in a patient with solid malignancy or nonmelanoma skin cancer that was treated more than 5 years ago, while rituximab should be considered in those treated for a solid malignancy within the last 5 years, those treated with nonmelanoma skin cancer within the last 5 years, those treated for skin melanoma, and those treated for lymphoproliferative malignancy.

The British Society of Rheumatology guidelines are "broadly similar but less restrictive on the use of rituximab, and less restrictive of the time duration from solid malignancy to decision making," Dr. McInnes said at Perspectives in Rheumatic Diseases 2013.

A number of studies looking at whether TNF inhibitors are associated with increased cancer risk have been published and, basically, "the more one looks at the data, the less concerned one becomes," he said.

In a large meta-analysis that included 74 randomized controlled studies, more than 15,400 patients treated with TNF inhibitors, and nearly 7,500 controls, investigators found no evidence to support or refute a link between TNF inhibitors treatment and short-term risk of all cancers except nonmelanoma skin cancer. The risk of nonmelanoma skin cancer, however, was nearly more than doubled in the treatment group (Pharmacoedpidemiol. Drug Saf. 2011;20:119-30).

A 2012 study demonstrated a very low risk of malignancy among patients on TNF inhibitors across several registries (Rheum. Dis. Clin. North Am. 2012;38:761-70).

Also, a study published earlier this year showed that, in nearly 40,000 patients with various types of rheumatic diseases, treatment with anti-TNF drugs was not associated with a short-term increase in the risk of cancer, compared with commonly used therapies for immune-mediated chronic inflammatory diseases (Arthritis Rheum. 2013;65:48-58).

Another large population-based cohort study published this year (BMJ 2013;346:f1939), showed that RA patients treated with TNF inhibitors are not at increased overall risk for cancer, but they do have a 50% increased relative risk of invasive melanoma. The increase in absolute melanoma risk is small, however, and "may not markedly shift the overall risk-benefit balance of TNF inhibitors as used in clinical practice but might do so in patients at high risk of melanoma for other reasons."

Notably, another large study published in 2011 linked data from multiple Swedish clinical registries of RA with nationwide data on hospitalization and outpatient visits for RA, showing that cancers that occur in patients taking TNF inhibitors are not characterized by any distinction, such as a later stage at presentation or worse survival.

"This is true whether you look at overall cancer or lung, colorectal, or hematologic cancers. You can reassure your patient," Dr. McInnes said.

As for RA patients with a history of prior malignancy, findings from a 2010 analysis of data from the British Society for Rheumatology Biologics Register showed that, in 117 patients on a DMARD and 177 on an anti-TNF drug, the risk of cancer was actually greater among those on a DMARD, with a rate of incident malignancy per 1,000 person-years of 25.3 in the anti-TNF patients, compared with 38.3 in the DMARD patients (Arthritis Care Res. 2010;62:755-63).

"When you look at the numbers they are, by and large, reassuring, and this is the message you should give to patients, but make decisions on an individual-patient basis," Dr. McInnes said.

Dr. McInnes disclosed that he has been a speaker, adviser, and/or investigator for Janssen, Roche, Pfizer, BMS, and Novartis. The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Concerns about use of a tumor necrosis factor inhibitor in a rheumatoid arthritis patient with a history of cancer are common, but the data are largely reassuring, according to Dr. Iain McInnes.

He used as an example a case involving a 56-year-old woman who had erosive RA that was anti-citrullinated peptide antibody–positive (ACPA+). The woman failed triple therapy, responded well to etanercept, and achieved clinical remission after 9 months. The patient then developed breast cancer and her TNF inhibitor was stopped, as recommended by current American College of Rheumatology guidelines.

The patient returned a year later after undergoing "the whole gamut from the oncological armamentarium," including chemotherapy, radiation therapy, and surgery.

"So what do you do? She wants her TNF blocker back – she did very well on it," said Dr. McInnes, who is Muirhead Chair of Medicine and Director of Institute of Infection, Immunity, and Inflammation at the University of Glasgow, Scotland.

Prescribe a conventional disease-modifying antirheumatic drug (DMARD)? Try a different mode of action?

What if the patient is a 56-year-old female with ACPA+ erosive RA who failed triple therapy and leflunomide; is doing poorly; has a history of breast cancer treated successfully 3 years ago by lumpectomy, radiation therapy and chemotherapy; and asks for a change in therapy?

According to the ACR guidelines, any biologic agent can be used in a patient with solid malignancy or nonmelanoma skin cancer that was treated more than 5 years ago, while rituximab should be considered in those treated for a solid malignancy within the last 5 years, those treated with nonmelanoma skin cancer within the last 5 years, those treated for skin melanoma, and those treated for lymphoproliferative malignancy.

The British Society of Rheumatology guidelines are "broadly similar but less restrictive on the use of rituximab, and less restrictive of the time duration from solid malignancy to decision making," Dr. McInnes said at Perspectives in Rheumatic Diseases 2013.

A number of studies looking at whether TNF inhibitors are associated with increased cancer risk have been published and, basically, "the more one looks at the data, the less concerned one becomes," he said.

In a large meta-analysis that included 74 randomized controlled studies, more than 15,400 patients treated with TNF inhibitors, and nearly 7,500 controls, investigators found no evidence to support or refute a link between TNF inhibitors treatment and short-term risk of all cancers except nonmelanoma skin cancer. The risk of nonmelanoma skin cancer, however, was nearly more than doubled in the treatment group (Pharmacoedpidemiol. Drug Saf. 2011;20:119-30).

A 2012 study demonstrated a very low risk of malignancy among patients on TNF inhibitors across several registries (Rheum. Dis. Clin. North Am. 2012;38:761-70).

Also, a study published earlier this year showed that, in nearly 40,000 patients with various types of rheumatic diseases, treatment with anti-TNF drugs was not associated with a short-term increase in the risk of cancer, compared with commonly used therapies for immune-mediated chronic inflammatory diseases (Arthritis Rheum. 2013;65:48-58).

Another large population-based cohort study published this year (BMJ 2013;346:f1939), showed that RA patients treated with TNF inhibitors are not at increased overall risk for cancer, but they do have a 50% increased relative risk of invasive melanoma. The increase in absolute melanoma risk is small, however, and "may not markedly shift the overall risk-benefit balance of TNF inhibitors as used in clinical practice but might do so in patients at high risk of melanoma for other reasons."

Notably, another large study published in 2011 linked data from multiple Swedish clinical registries of RA with nationwide data on hospitalization and outpatient visits for RA, showing that cancers that occur in patients taking TNF inhibitors are not characterized by any distinction, such as a later stage at presentation or worse survival.

"This is true whether you look at overall cancer or lung, colorectal, or hematologic cancers. You can reassure your patient," Dr. McInnes said.

As for RA patients with a history of prior malignancy, findings from a 2010 analysis of data from the British Society for Rheumatology Biologics Register showed that, in 117 patients on a DMARD and 177 on an anti-TNF drug, the risk of cancer was actually greater among those on a DMARD, with a rate of incident malignancy per 1,000 person-years of 25.3 in the anti-TNF patients, compared with 38.3 in the DMARD patients (Arthritis Care Res. 2010;62:755-63).

"When you look at the numbers they are, by and large, reassuring, and this is the message you should give to patients, but make decisions on an individual-patient basis," Dr. McInnes said.

Dr. McInnes disclosed that he has been a speaker, adviser, and/or investigator for Janssen, Roche, Pfizer, BMS, and Novartis. The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Concerns about use of a tumor necrosis factor inhibitor in a rheumatoid arthritis patient with a history of cancer are common, but the data are largely reassuring, according to Dr. Iain McInnes.

He used as an example a case involving a 56-year-old woman who had erosive RA that was anti-citrullinated peptide antibody–positive (ACPA+). The woman failed triple therapy, responded well to etanercept, and achieved clinical remission after 9 months. The patient then developed breast cancer and her TNF inhibitor was stopped, as recommended by current American College of Rheumatology guidelines.

The patient returned a year later after undergoing "the whole gamut from the oncological armamentarium," including chemotherapy, radiation therapy, and surgery.

"So what do you do? She wants her TNF blocker back – she did very well on it," said Dr. McInnes, who is Muirhead Chair of Medicine and Director of Institute of Infection, Immunity, and Inflammation at the University of Glasgow, Scotland.

Prescribe a conventional disease-modifying antirheumatic drug (DMARD)? Try a different mode of action?

What if the patient is a 56-year-old female with ACPA+ erosive RA who failed triple therapy and leflunomide; is doing poorly; has a history of breast cancer treated successfully 3 years ago by lumpectomy, radiation therapy and chemotherapy; and asks for a change in therapy?

According to the ACR guidelines, any biologic agent can be used in a patient with solid malignancy or nonmelanoma skin cancer that was treated more than 5 years ago, while rituximab should be considered in those treated for a solid malignancy within the last 5 years, those treated with nonmelanoma skin cancer within the last 5 years, those treated for skin melanoma, and those treated for lymphoproliferative malignancy.

The British Society of Rheumatology guidelines are "broadly similar but less restrictive on the use of rituximab, and less restrictive of the time duration from solid malignancy to decision making," Dr. McInnes said at Perspectives in Rheumatic Diseases 2013.

A number of studies looking at whether TNF inhibitors are associated with increased cancer risk have been published and, basically, "the more one looks at the data, the less concerned one becomes," he said.

In a large meta-analysis that included 74 randomized controlled studies, more than 15,400 patients treated with TNF inhibitors, and nearly 7,500 controls, investigators found no evidence to support or refute a link between TNF inhibitors treatment and short-term risk of all cancers except nonmelanoma skin cancer. The risk of nonmelanoma skin cancer, however, was nearly more than doubled in the treatment group (Pharmacoedpidemiol. Drug Saf. 2011;20:119-30).

A 2012 study demonstrated a very low risk of malignancy among patients on TNF inhibitors across several registries (Rheum. Dis. Clin. North Am. 2012;38:761-70).

Also, a study published earlier this year showed that, in nearly 40,000 patients with various types of rheumatic diseases, treatment with anti-TNF drugs was not associated with a short-term increase in the risk of cancer, compared with commonly used therapies for immune-mediated chronic inflammatory diseases (Arthritis Rheum. 2013;65:48-58).

Another large population-based cohort study published this year (BMJ 2013;346:f1939), showed that RA patients treated with TNF inhibitors are not at increased overall risk for cancer, but they do have a 50% increased relative risk of invasive melanoma. The increase in absolute melanoma risk is small, however, and "may not markedly shift the overall risk-benefit balance of TNF inhibitors as used in clinical practice but might do so in patients at high risk of melanoma for other reasons."

Notably, another large study published in 2011 linked data from multiple Swedish clinical registries of RA with nationwide data on hospitalization and outpatient visits for RA, showing that cancers that occur in patients taking TNF inhibitors are not characterized by any distinction, such as a later stage at presentation or worse survival.

"This is true whether you look at overall cancer or lung, colorectal, or hematologic cancers. You can reassure your patient," Dr. McInnes said.

As for RA patients with a history of prior malignancy, findings from a 2010 analysis of data from the British Society for Rheumatology Biologics Register showed that, in 117 patients on a DMARD and 177 on an anti-TNF drug, the risk of cancer was actually greater among those on a DMARD, with a rate of incident malignancy per 1,000 person-years of 25.3 in the anti-TNF patients, compared with 38.3 in the DMARD patients (Arthritis Care Res. 2010;62:755-63).

"When you look at the numbers they are, by and large, reassuring, and this is the message you should give to patients, but make decisions on an individual-patient basis," Dr. McInnes said.

Dr. McInnes disclosed that he has been a speaker, adviser, and/or investigator for Janssen, Roche, Pfizer, BMS, and Novartis. The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

LAS VEGAS – Should live attenuated herpes zoster vaccine be administered to a 45-year-old patient with mild rheumatoid arthritis and a strong family history of autoimmune disease? Should it be administered to a patient with long-standing RA who is seropositive and taking methotrexate and prednisone?

Many physicians are justifiably concerned about whether vaccination could cause autoimmune disease, Dr. Daniel E. Furst said at the Perspectives in Rheumatic Diseases 2013 meeting.

"And there is a lot of rationale for this to happen," he said, explaining that vaccination theoretically has the potential to activate the innate immune system or cause an allergic reaction that may accelerate the immune response.

The available data "aren’t fantastic" and they tend to conflict, but they do provide some guidance, said Dr. Furst, the Carl M. Pearson Professor of Rheumatology at the University of California, Los Angeles.

A few cases of Guillain-Barré syndrome have occurred after administration of the H1N1 flu vaccine (about 1 in 100,000), and idiopathic thrombocytopenic purpura has occurred following measles, mumps, and rubella (MMR) vaccine (about 1 in 30,000), he said.

Reports regarding multiple sclerosis following hepatitis B vaccination have been conflicting.

For the first case – a 45-year-old man with a strong family history of autoimmune disease who had mild RA, with occasional wrist and knee pain but no swelling – Dr. Furst said he would tell the patient there is "very little going on there" in terms of concern about activating autoimmune disease, and he would likely provide the vaccine.

In the second case, however, it is important to consider the known increased risk of developing herpes zoster among patients with rheumatic diseases (about a twofold increased risk, largely due to prednisone use), and the risks associated with providing the vaccine – including the added risk that would come with adding a biologic to the treatment regimen.

The risk is further increased by the use of both anti–tumor necrosis factor (anti-TNF) and non–anti-TNF biologics, he said.

"It appears that anything you do to suppress the immune system increases the risk," he added.

The question is whether the benefits of vaccinating outweigh the risks. Herpes zoster vaccination is associated with about a 40% reduction in the risk of shingles in this patient population. In one retrospective study of more than 460,000 Medicare patients, about 18,000 developed herpes zoster. However, in 663 patients who were on anti-TNF therapy and who were vaccinated, none developed a disseminated case in the 42 days following vaccination.

"What this seems to suggest is that yes, you can [vaccinate]," he said. But because that evidence is from a retrospective study, he advised that if you choose to vaccinate these patients, "you better have your thoughts well organized and tell the patient there is some increased risk."

In his practice, he continues to vaccinate only before initiating biologic therapy or after a washout period.

"The evidence isn’t strong enough to change my practice," he said.

According to recommendations from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, vaccination is okay in rheumatic disease patients who are on low-dose prednisone (less than 20 mg/day) and in those on low doses of methotrexate (less than 0.4 mg/kg per week), azathioprine (less than 3.0 mg/kg per day), or 6-mercaptopurine (1.5 mg/kg per day or less), but should be avoided in transplant patients, those who have active lymphomas or HIV, and those using high-dose steroids.

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furst reported serving as a consultant or speaker for, and/or receiving research or grant support from, AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Celgene, Janssen, Genentech/Roche, Gilead, GlaxoSmithKline, Novartis, Pfizer, and UCB. He has received grant support from the National Institutes of Health.

LAS VEGAS – Psoriasiform eruptions are increasingly recognized as a "real event" among patients treated with anti–tumor necrosis factor therapy, according to Dr. Kenneth B. Gordon.

At Perspectives in Rheumatic Diseases 2013, Dr. Gordon of Northwestern University in Chicago presented the case of a 56-year-old woman with Crohn’s disease who developed a painful rash with fissures on both hands about 8 months after starting adalimumab therapy.

The patient first presented with Crohn’s disease at age 28 and was initially treated with mesalamine and systemic corticosteroids for flares. She became prednisone dependent and was started on azathioprine, but could not tolerate the drug, which caused pancreatitis. She was switched to adalimumab at a dose of 80 mg at week 1, 40 mg at week 2, and then 40 mg every other week thereafter.

The patient had an excellent response, including resolution of the gastrointestinal symptoms she experienced on azathioprine, but the rash, which involved well-demarcated plaques suggestive of a psoriasiform structure, was debilitating, Dr. Gordon said.

Another case, presented by Dr. Iain McInnes of Glasgow University, Scotland, involved a patient undergoing anti–tumor necrosis factor (anti-TNF) therapy for rheumatoid arthritis. That patient also developed palmar-plantar pustular psoriasis, which is the most common presentation of psoriasis induced by anti-TNF agents.

Data on the frequency of this condition are lacking, but Dr. Gordon said his "best guess" based on the available literature is that it occurs in about 1%-2% of patients on TNF blockers.

Dr. McInnes described the frequency as "sufficiently common to know it happens and reassure patients about it; sufficiently uncommon enough not to influence decision making" about prescribing anti-TNF therapy.

According to a 2010 systematic literature review by Dr. Angelique N. Collamer and Dr. Daniel F. Battafarano of the rheumatology service at Brooke Army Medical Center in Fort Sam Houston, Tex., pustular psoriasis occurs in 56% of cases, plaque psoriasis occurs in 50%, and guttate psoriasis occurs in 12% of cases. Most (85%) are new-onset cases, and 15% represent an exacerbation of existing psoriasis. Also, patients who are being treated for a variety of diseases – including rheumatoid arthritis, seronegative spondyloarthropathy, inflammatory bowel disease, and psoriasis – may be affected, and all anti-TNF therapies have been implicated (Semin. Arthritis Rheum. 2010;40:233-40).

However, treatment does not necessarily require stopping the TNF blockers, which is important because many patients don’t want to stop – they’re pleased with the effects of treatment on their underlying disease, Dr. Gordon noted.

He said that the first-line treatment is topical therapy, such as a potent topical corticosteroid, but retinoids may also be needed. Other options include phototherapy and switching to another anti-TNF therapy.

"My philosophy is to try to treat the patient while maintaining [anti-TNF] treatment," he said, noting that stopping anti-TNF therapy is a last resort.

Although the patient Dr. Gordon discussed was not a smoker, smoking is a risk factor for worsening of palm psoriasis. Patients with this condition should be advised to quit smoking, and many smokers will get better just by quitting smoking, Dr. Gordon noted.

Dr. McInnes also outlined his approach to patients presenting with possible anti-TNF therapy–induced psoriasis.

He stressed the importance of a good differential diagnosis, noting that infection may be the actual cause.

A biopsy can sometimes help with the diagnosis, he said.

In general, his treatment approach in cases of true anti-TNF–induced psoriasis is to:

• Continue the anti-TNF therapy when less than 5% of body surface area is affected.

• Change to a different anti-TNF drug if the psoriasis is tolerable but appears "a little more severe or is a palmar-pustular variant." The timing of the change will depend on how the patient responds to cutaneous management.

• Stop the drug if the psoriasis is intolerable, and treat the psoriasis aggressively.

In any of these circumstances, a change in the mode of action of treatment may be warranted, he said at the meeting.

In the review by Dr. Collamer and Dr. Battafarano, 24% of patients resolved off anti-TNF therapy, 5% had partial or no resolution off anti-TNF therapy, 25% had partial resolution on anti-TNF therapy, and 6% had no recurrence with change of anti-TNF. Only 1% had no resolution on anti-TNF therapy, and only 2% who resolved after anti-TNF discontinuation then had recurrence after reintroduction of anti-TNF therapy, while 6% resolved off anti-TNF therapy and then had recurrence with introduction of a different anti-TNF. The outcome was unknown in 5% of patients. A Mayo Clinic series showed a similar breakdown (J. Am. Acad. Dermatol. 2012;67:e179-85).

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Gordon reported receiving research support and/or honoraria from AbbVie, Amgen, and other companies. Dr. McInnes reported serving as a speaker, adviser, and/or researcher for Janssen, Roche, and other companies.

LAS VEGAS – Psoriasiform eruptions are increasingly recognized as a "real event" among patients treated with anti–tumor necrosis factor therapy, according to Dr. Kenneth B. Gordon.

At Perspectives in Rheumatic Diseases 2013, Dr. Gordon of Northwestern University in Chicago presented the case of a 56-year-old woman with Crohn’s disease who developed a painful rash with fissures on both hands about 8 months after starting adalimumab therapy.

The patient first presented with Crohn’s disease at age 28 and was initially treated with mesalamine and systemic corticosteroids for flares. She became prednisone dependent and was started on azathioprine, but could not tolerate the drug, which caused pancreatitis. She was switched to adalimumab at a dose of 80 mg at week 1, 40 mg at week 2, and then 40 mg every other week thereafter.

The patient had an excellent response, including resolution of the gastrointestinal symptoms she experienced on azathioprine, but the rash, which involved well-demarcated plaques suggestive of a psoriasiform structure, was debilitating, Dr. Gordon said.

Another case, presented by Dr. Iain McInnes of Glasgow University, Scotland, involved a patient undergoing anti–tumor necrosis factor (anti-TNF) therapy for rheumatoid arthritis. That patient also developed palmar-plantar pustular psoriasis, which is the most common presentation of psoriasis induced by anti-TNF agents.

Data on the frequency of this condition are lacking, but Dr. Gordon said his "best guess" based on the available literature is that it occurs in about 1%-2% of patients on TNF blockers.

Dr. McInnes described the frequency as "sufficiently common to know it happens and reassure patients about it; sufficiently uncommon enough not to influence decision making" about prescribing anti-TNF therapy.

According to a 2010 systematic literature review by Dr. Angelique N. Collamer and Dr. Daniel F. Battafarano of the rheumatology service at Brooke Army Medical Center in Fort Sam Houston, Tex., pustular psoriasis occurs in 56% of cases, plaque psoriasis occurs in 50%, and guttate psoriasis occurs in 12% of cases. Most (85%) are new-onset cases, and 15% represent an exacerbation of existing psoriasis. Also, patients who are being treated for a variety of diseases – including rheumatoid arthritis, seronegative spondyloarthropathy, inflammatory bowel disease, and psoriasis – may be affected, and all anti-TNF therapies have been implicated (Semin. Arthritis Rheum. 2010;40:233-40).

However, treatment does not necessarily require stopping the TNF blockers, which is important because many patients don’t want to stop – they’re pleased with the effects of treatment on their underlying disease, Dr. Gordon noted.

He said that the first-line treatment is topical therapy, such as a potent topical corticosteroid, but retinoids may also be needed. Other options include phototherapy and switching to another anti-TNF therapy.

"My philosophy is to try to treat the patient while maintaining [anti-TNF] treatment," he said, noting that stopping anti-TNF therapy is a last resort.

Although the patient Dr. Gordon discussed was not a smoker, smoking is a risk factor for worsening of palm psoriasis. Patients with this condition should be advised to quit smoking, and many smokers will get better just by quitting smoking, Dr. Gordon noted.

Dr. McInnes also outlined his approach to patients presenting with possible anti-TNF therapy–induced psoriasis.

He stressed the importance of a good differential diagnosis, noting that infection may be the actual cause.

A biopsy can sometimes help with the diagnosis, he said.

In general, his treatment approach in cases of true anti-TNF–induced psoriasis is to:

• Continue the anti-TNF therapy when less than 5% of body surface area is affected.

• Change to a different anti-TNF drug if the psoriasis is tolerable but appears "a little more severe or is a palmar-pustular variant." The timing of the change will depend on how the patient responds to cutaneous management.

• Stop the drug if the psoriasis is intolerable, and treat the psoriasis aggressively.

In any of these circumstances, a change in the mode of action of treatment may be warranted, he said at the meeting.

In the review by Dr. Collamer and Dr. Battafarano, 24% of patients resolved off anti-TNF therapy, 5% had partial or no resolution off anti-TNF therapy, 25% had partial resolution on anti-TNF therapy, and 6% had no recurrence with change of anti-TNF. Only 1% had no resolution on anti-TNF therapy, and only 2% who resolved after anti-TNF discontinuation then had recurrence after reintroduction of anti-TNF therapy, while 6% resolved off anti-TNF therapy and then had recurrence with introduction of a different anti-TNF. The outcome was unknown in 5% of patients. A Mayo Clinic series showed a similar breakdown (J. Am. Acad. Dermatol. 2012;67:e179-85).

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Gordon reported receiving research support and/or honoraria from AbbVie, Amgen, and other companies. Dr. McInnes reported serving as a speaker, adviser, and/or researcher for Janssen, Roche, and other companies.

LAS VEGAS – Psoriasiform eruptions are increasingly recognized as a "real event" among patients treated with anti–tumor necrosis factor therapy, according to Dr. Kenneth B. Gordon.

At Perspectives in Rheumatic Diseases 2013, Dr. Gordon of Northwestern University in Chicago presented the case of a 56-year-old woman with Crohn’s disease who developed a painful rash with fissures on both hands about 8 months after starting adalimumab therapy.

The patient first presented with Crohn’s disease at age 28 and was initially treated with mesalamine and systemic corticosteroids for flares. She became prednisone dependent and was started on azathioprine, but could not tolerate the drug, which caused pancreatitis. She was switched to adalimumab at a dose of 80 mg at week 1, 40 mg at week 2, and then 40 mg every other week thereafter.

The patient had an excellent response, including resolution of the gastrointestinal symptoms she experienced on azathioprine, but the rash, which involved well-demarcated plaques suggestive of a psoriasiform structure, was debilitating, Dr. Gordon said.

Another case, presented by Dr. Iain McInnes of Glasgow University, Scotland, involved a patient undergoing anti–tumor necrosis factor (anti-TNF) therapy for rheumatoid arthritis. That patient also developed palmar-plantar pustular psoriasis, which is the most common presentation of psoriasis induced by anti-TNF agents.

Data on the frequency of this condition are lacking, but Dr. Gordon said his "best guess" based on the available literature is that it occurs in about 1%-2% of patients on TNF blockers.

Dr. McInnes described the frequency as "sufficiently common to know it happens and reassure patients about it; sufficiently uncommon enough not to influence decision making" about prescribing anti-TNF therapy.

According to a 2010 systematic literature review by Dr. Angelique N. Collamer and Dr. Daniel F. Battafarano of the rheumatology service at Brooke Army Medical Center in Fort Sam Houston, Tex., pustular psoriasis occurs in 56% of cases, plaque psoriasis occurs in 50%, and guttate psoriasis occurs in 12% of cases. Most (85%) are new-onset cases, and 15% represent an exacerbation of existing psoriasis. Also, patients who are being treated for a variety of diseases – including rheumatoid arthritis, seronegative spondyloarthropathy, inflammatory bowel disease, and psoriasis – may be affected, and all anti-TNF therapies have been implicated (Semin. Arthritis Rheum. 2010;40:233-40).

However, treatment does not necessarily require stopping the TNF blockers, which is important because many patients don’t want to stop – they’re pleased with the effects of treatment on their underlying disease, Dr. Gordon noted.

He said that the first-line treatment is topical therapy, such as a potent topical corticosteroid, but retinoids may also be needed. Other options include phototherapy and switching to another anti-TNF therapy.

"My philosophy is to try to treat the patient while maintaining [anti-TNF] treatment," he said, noting that stopping anti-TNF therapy is a last resort.

Although the patient Dr. Gordon discussed was not a smoker, smoking is a risk factor for worsening of palm psoriasis. Patients with this condition should be advised to quit smoking, and many smokers will get better just by quitting smoking, Dr. Gordon noted.

Dr. McInnes also outlined his approach to patients presenting with possible anti-TNF therapy–induced psoriasis.

He stressed the importance of a good differential diagnosis, noting that infection may be the actual cause.

A biopsy can sometimes help with the diagnosis, he said.

In general, his treatment approach in cases of true anti-TNF–induced psoriasis is to:

• Continue the anti-TNF therapy when less than 5% of body surface area is affected.

• Change to a different anti-TNF drug if the psoriasis is tolerable but appears "a little more severe or is a palmar-pustular variant." The timing of the change will depend on how the patient responds to cutaneous management.

• Stop the drug if the psoriasis is intolerable, and treat the psoriasis aggressively.

In any of these circumstances, a change in the mode of action of treatment may be warranted, he said at the meeting.

In the review by Dr. Collamer and Dr. Battafarano, 24% of patients resolved off anti-TNF therapy, 5% had partial or no resolution off anti-TNF therapy, 25% had partial resolution on anti-TNF therapy, and 6% had no recurrence with change of anti-TNF. Only 1% had no resolution on anti-TNF therapy, and only 2% who resolved after anti-TNF discontinuation then had recurrence after reintroduction of anti-TNF therapy, while 6% resolved off anti-TNF therapy and then had recurrence with introduction of a different anti-TNF. The outcome was unknown in 5% of patients. A Mayo Clinic series showed a similar breakdown (J. Am. Acad. Dermatol. 2012;67:e179-85).

The meeting was held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Gordon reported receiving research support and/or honoraria from AbbVie, Amgen, and other companies. Dr. McInnes reported serving as a speaker, adviser, and/or researcher for Janssen, Roche, and other companies.

LAS VEGAS – The future looks bright for lupus treatment given the extensive list of drugs and targets currently undergoing evaluation, but for now treatment remains largely an art, according to Dr. Richard Furie.

"We try to integrate science, but it really is an art – these patients are very difficult," he said at the meeting.

That’s because of the heterogeneity of the disease, and the need to balance the benefits of treatment against the potential harms, which are extensive with currently available drugs, he explained.

Success is best achieved by "getting back to basics," he added.

First, as simple as it sounds, "do good" by controlling disease activity, preventing damage from disease, and preventing flares – as even one flare can cause damage – and "do no harm," which requires preventing damage from treatment and avoiding the treatment of damage with agents intended for active disease, he said.

"This is difficult, but the last thing we want to do is bombard a patient with potentially toxic medication when they are not going to reverse damage. ... We have a lot of potentially harmful medications. ... The name of the game is to minimize damage over time," said Dr. Furie, chief of the division of rheumatology at North Shore–LIJ Health System and professor of medicine at Hofstra North Shore–LIJ School of Medicine in Hempstead, N.Y.

Dr. Furie outlined his principles for treatment design:

• Identify disease manifestations.

• Distinguish activity from chronicity. For example, it is important to determine if a rash represents active disease or a scar, and whether proteinuria represents active nephritis or previous damage.

• Prioritize active disease manifestations.

• View disease activity as a continuum.

• Treat with the least toxic medicine and the lowest dose needed to address the most concerning disease manifestation. This will hopefully bring other manifestations under control as well, but treating too aggressively can lead to unnecessary damage, he said.

As for currently available treatments, "we’ve come a long way and patients are doing better," he said.

But the number of medications remains limited, and a great deal more work must be done, particularly with respect to lupus nephritis.

"At best, we do a good job with treatment in about 30%-40% of [patients with lupus nephritis], so in more than half we’re not doing well," he said.

More efficacious therapies are also needed for severe extrarenal lupus, flare prevention, and remission induction, he said, noting that treatments that are safer than steroids and cyclophosphamide also are needed.

Among currently used treatments, rituximab, while promising in open-label studies and off-label experience, has had disappointing results in randomized, controlled clinical trials. It nonetheless remains "in the toolbox," Dr. Furie said, noting that interest remains high in studying the agent for nephritis.

Mycophenolate mofetil also has been disappointing, in that it failed to show superiority to cyclophosphamide in the Aspreva Lupus Management Study (ALMS). However, Dr. Furie classified this drug as a "successful failure," because ALMS demonstrated what many had already believed – that mycophenolate mofetil is a good drug for lupus nephritis (J. Am. Soc. Nephrol. 2009;20:1103-12) .

Another agent, belimumab, on the other hand, represents a success story – and a history-making success story at that, he said.

Belimumab was the first drug approved for SLE via a randomized controlled trial, he explained, noting that it has favorable effects on steroid tapering to under 7.5 mg/day, 36-Item Short Form Health Survey (SF-36) fatigue scores, flare rates, and DNA antibody and complement levels – all with a favorable safety profile.

Unfortunately, the failures outweigh the successes with respect to the "humbling process" of drug development, but many drugs and targets are currently being investigated, he said.

In fact, there are more studies than there are patients, he said, adding, "but it still strikes me how many companies want to go forward in lupus, and I think it’s great for the field."

"There are a lot of interesting drugs on the horizon. ... We will someday have biomarkers, personalized therapy, and better outcomes," he said at the meeting, held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furie reported receiving research support and/or serving as a consultant or investigator for several companies, including AstraZeneca, Biogen Idec, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, and Novartis. He also has received research support from the National Institute of Allergy and Infectious Diseases.

LAS VEGAS – The future looks bright for lupus treatment given the extensive list of drugs and targets currently undergoing evaluation, but for now treatment remains largely an art, according to Dr. Richard Furie.

"We try to integrate science, but it really is an art – these patients are very difficult," he said at the meeting.

That’s because of the heterogeneity of the disease, and the need to balance the benefits of treatment against the potential harms, which are extensive with currently available drugs, he explained.

Success is best achieved by "getting back to basics," he added.

First, as simple as it sounds, "do good" by controlling disease activity, preventing damage from disease, and preventing flares – as even one flare can cause damage – and "do no harm," which requires preventing damage from treatment and avoiding the treatment of damage with agents intended for active disease, he said.

"This is difficult, but the last thing we want to do is bombard a patient with potentially toxic medication when they are not going to reverse damage. ... We have a lot of potentially harmful medications. ... The name of the game is to minimize damage over time," said Dr. Furie, chief of the division of rheumatology at North Shore–LIJ Health System and professor of medicine at Hofstra North Shore–LIJ School of Medicine in Hempstead, N.Y.

Dr. Furie outlined his principles for treatment design:

• Identify disease manifestations.

• Distinguish activity from chronicity. For example, it is important to determine if a rash represents active disease or a scar, and whether proteinuria represents active nephritis or previous damage.

• Prioritize active disease manifestations.

• View disease activity as a continuum.

• Treat with the least toxic medicine and the lowest dose needed to address the most concerning disease manifestation. This will hopefully bring other manifestations under control as well, but treating too aggressively can lead to unnecessary damage, he said.

As for currently available treatments, "we’ve come a long way and patients are doing better," he said.

But the number of medications remains limited, and a great deal more work must be done, particularly with respect to lupus nephritis.

"At best, we do a good job with treatment in about 30%-40% of [patients with lupus nephritis], so in more than half we’re not doing well," he said.

More efficacious therapies are also needed for severe extrarenal lupus, flare prevention, and remission induction, he said, noting that treatments that are safer than steroids and cyclophosphamide also are needed.

Among currently used treatments, rituximab, while promising in open-label studies and off-label experience, has had disappointing results in randomized, controlled clinical trials. It nonetheless remains "in the toolbox," Dr. Furie said, noting that interest remains high in studying the agent for nephritis.

Mycophenolate mofetil also has been disappointing, in that it failed to show superiority to cyclophosphamide in the Aspreva Lupus Management Study (ALMS). However, Dr. Furie classified this drug as a "successful failure," because ALMS demonstrated what many had already believed – that mycophenolate mofetil is a good drug for lupus nephritis (J. Am. Soc. Nephrol. 2009;20:1103-12) .

Another agent, belimumab, on the other hand, represents a success story – and a history-making success story at that, he said.

Belimumab was the first drug approved for SLE via a randomized controlled trial, he explained, noting that it has favorable effects on steroid tapering to under 7.5 mg/day, 36-Item Short Form Health Survey (SF-36) fatigue scores, flare rates, and DNA antibody and complement levels – all with a favorable safety profile.

Unfortunately, the failures outweigh the successes with respect to the "humbling process" of drug development, but many drugs and targets are currently being investigated, he said.

In fact, there are more studies than there are patients, he said, adding, "but it still strikes me how many companies want to go forward in lupus, and I think it’s great for the field."

"There are a lot of interesting drugs on the horizon. ... We will someday have biomarkers, personalized therapy, and better outcomes," he said at the meeting, held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furie reported receiving research support and/or serving as a consultant or investigator for several companies, including AstraZeneca, Biogen Idec, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, and Novartis. He also has received research support from the National Institute of Allergy and Infectious Diseases.

LAS VEGAS – The future looks bright for lupus treatment given the extensive list of drugs and targets currently undergoing evaluation, but for now treatment remains largely an art, according to Dr. Richard Furie.

"We try to integrate science, but it really is an art – these patients are very difficult," he said at the meeting.

That’s because of the heterogeneity of the disease, and the need to balance the benefits of treatment against the potential harms, which are extensive with currently available drugs, he explained.

Success is best achieved by "getting back to basics," he added.

First, as simple as it sounds, "do good" by controlling disease activity, preventing damage from disease, and preventing flares – as even one flare can cause damage – and "do no harm," which requires preventing damage from treatment and avoiding the treatment of damage with agents intended for active disease, he said.

"This is difficult, but the last thing we want to do is bombard a patient with potentially toxic medication when they are not going to reverse damage. ... We have a lot of potentially harmful medications. ... The name of the game is to minimize damage over time," said Dr. Furie, chief of the division of rheumatology at North Shore–LIJ Health System and professor of medicine at Hofstra North Shore–LIJ School of Medicine in Hempstead, N.Y.

Dr. Furie outlined his principles for treatment design:

• Identify disease manifestations.

• Distinguish activity from chronicity. For example, it is important to determine if a rash represents active disease or a scar, and whether proteinuria represents active nephritis or previous damage.

• Prioritize active disease manifestations.

• View disease activity as a continuum.

• Treat with the least toxic medicine and the lowest dose needed to address the most concerning disease manifestation. This will hopefully bring other manifestations under control as well, but treating too aggressively can lead to unnecessary damage, he said.

As for currently available treatments, "we’ve come a long way and patients are doing better," he said.

But the number of medications remains limited, and a great deal more work must be done, particularly with respect to lupus nephritis.

"At best, we do a good job with treatment in about 30%-40% of [patients with lupus nephritis], so in more than half we’re not doing well," he said.

More efficacious therapies are also needed for severe extrarenal lupus, flare prevention, and remission induction, he said, noting that treatments that are safer than steroids and cyclophosphamide also are needed.

Among currently used treatments, rituximab, while promising in open-label studies and off-label experience, has had disappointing results in randomized, controlled clinical trials. It nonetheless remains "in the toolbox," Dr. Furie said, noting that interest remains high in studying the agent for nephritis.

Mycophenolate mofetil also has been disappointing, in that it failed to show superiority to cyclophosphamide in the Aspreva Lupus Management Study (ALMS). However, Dr. Furie classified this drug as a "successful failure," because ALMS demonstrated what many had already believed – that mycophenolate mofetil is a good drug for lupus nephritis (J. Am. Soc. Nephrol. 2009;20:1103-12) .

Another agent, belimumab, on the other hand, represents a success story – and a history-making success story at that, he said.

Belimumab was the first drug approved for SLE via a randomized controlled trial, he explained, noting that it has favorable effects on steroid tapering to under 7.5 mg/day, 36-Item Short Form Health Survey (SF-36) fatigue scores, flare rates, and DNA antibody and complement levels – all with a favorable safety profile.

Unfortunately, the failures outweigh the successes with respect to the "humbling process" of drug development, but many drugs and targets are currently being investigated, he said.

In fact, there are more studies than there are patients, he said, adding, "but it still strikes me how many companies want to go forward in lupus, and I think it’s great for the field."

"There are a lot of interesting drugs on the horizon. ... We will someday have biomarkers, personalized therapy, and better outcomes," he said at the meeting, held by Global Academy for Medical Education. GAME and this news organization are owned by Frontline Medical Communications.

Dr. Furie reported receiving research support and/or serving as a consultant or investigator for several companies, including AstraZeneca, Biogen Idec, Bristol-Myers Squibb, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, and Novartis. He also has received research support from the National Institute of Allergy and Infectious Diseases.

LAS VEGAS – A coalition working to address dual-energy X-ray absorptiometry access issues is developing draft legislation that would establish a geographically adjusted national minimum payment for DXA, according to Dr. Michael Schweitz.

Under the draft legislation – a response to a series of reimbursement cuts over the past several years – DXA CPT codes 77080 and 77082 would be paid at $98 and $35, respectively, and a bundled code or bundled payment for bone density and vertebral fracture assessment studies would result in a national minimum payment of $133, Dr. Schweitz, president of the Coalition of State Rheumatology Organizations, said at Perspectives in Rheumatic Diseases 2013 during an update on federal legislative and regulatory issues facing rheumatologists.

Restoring reimbursement is an issue on the "front burner," he said, noting that studies have demonstrated an increase in hip fracture rates in the wake of declining reimbursement as some practices have abandoned DXA.

The DXA draft legislation is just one of a number of current legislative initiatives and issues that should be on rheumatologists’ radar, Dr. Schweitz said.

Sequestration

Under sequestration – a "heavy hammer" proposed as a way to push for agreement on a deficit-reduction plan and implemented when that agreement didn’t materialize – Medicare provider reductions are limited to 2% per year. Claims are reduced by 2% after beneficiary coinsurance or deductible. H.R. 1416, the Cancer Patient Protection Act of 2013, would terminate sequester cuts for all part B drugs, not just cancer drugs.

Medicare physician payment

Based on the formula for the Medicare sustainable growth rate, or SGR, physician payments will be cut by 24.4% if Congress does not intervene by Jan. 1, 2014. The latest cost estimate by the Congressional Budget Office for repeal of the SGR is $176 billion – far less than previous estimates and far less than the combined cost of prior short-term patches. President Barack Obama’s 2014 budget, as well as Congressional budgets and recent federal rulemakings, all assume that Congress will fix the SGR this year. Draft legislation released in July based on a replacement proposal from the bipartisan House Energy & Commerce Committee calls for a two-phase approach. Phase I would repeal the SGR entirely and replace it with a 5-year period of stable payments, including a 0.5% increase across-the-board, and phase II would involve implementation of an enhanced "PQRS-like Update Incentive Program." This would maintain fee-for-service as an option, allow providers to move into other models at any time, and would involve physician-driven quality measurement.

"This is something all of us should be aware of ... you can be sure that this whole system of reimbursement for what we do is going to change in the future," said Dr. Schweitz, who has a private practice in West Palm Beach, Fla.

How the changes would be paid for has not been defined, but there is a proposal from the House Ways & Means Committee that involves entitlement reform with increased part B/D deductibles and an increased age for eligibility.

Part B drug payments

A new bill (H.R. 800) that would affect physicians who provide in-office drug infusion excludes prompt pay discounts from manufacturers to wholesalers from the average sales price (ASP) calculation for part B drugs. This would improve payment for physicians who do not receive the discounts. However, the president’s 2014 budget assumes part B drugs are overpaid and proposes reducing Medicare payment from ASP plus 6% to ASP plus 3%.

This would require legislation to enact. The House and Senate budgets do not include any assumption regarding ASP.

"There’s very little chance, I think, that either side is going to be successful with this," Dr. Schweitz said.

The Independent Payment Advisory Board

The IPAB, a 15-member board created as part of the Affordable Care Act to make recommendations to cut spending when costs exceed growth targets, has been a contentious issue.

"There is a huge outcry in Congress against this IPAB," Dr. Schweitz said, explaining that there is a sense that the IPAB represents a usurping of the authority of Congress in controlling this part of Medicare activity.

A bipartisan repeal effort is underway in the form of H.R. 351/S. 351, the Protecting Seniors’ Access to Medicare Act. This has a chance of moving forward, but opposition in the Senate could hold it back, Dr. Schweitz said.

Of note, the president’s 2014 budget would lower the target rate that triggers IPAB recommendations from gross domestic product plus 1% to GDP plus 0.5%. Also, House Speaker John Boehner (R-Ohio) and Senate Minority Leader Mitch McConnell (R-Ky.) are on record saying that they will not nominate members to the IPAB, he said.

Private contracting

Private contracting is permitted under current law, but physicians who engage in it must opt out of Medicare for 2 years; patients who sign a private contract must pay out of pocket, even for services covered by Medicare. Under S. 236/H.R. 1310 – the Medicare Patient Empowerment Act – the 2-year opt-out requirement would be eliminated and beneficiaries could use their benefits to offset a portion of the fee set by their physician. This would protect low-income patients, "dual-eligibles," and patients with certain emergent or urgent health conditions. It is opposed by the Democratic Party and AARP, who see it as a cost-shifting mechanism; others feel it is a way to help reduce Medicare spending, he noted.

Medical liability reform

There’s been "a lot of noise but not much action" when it comes to medical liability reform, Dr. Schweitz said.

A House bill that would have included a $250,000 cap on noneconomic damages was paired with the IPAB repeal bill in the 112th Congress but did not make it to the Senate.

"There’s no such bill active in this [113th] Congress, but there are other kinds of liability reform acts that are more focused," he said.

These include H.R. 36/S. 961, the Health Care Safety Net Enhancement Act of 2013, which would extend Federal Tort Claims Act liability protections to on-call specialty physicians; H.R. 1733, the Good Samaritan Health Professionals Act of 2013, which would limit liability of health care professionals who volunteer to provide health care in response to a declared natural disaster; and H.R. 1473, the Standard of Care Protection Act, which would protect physicians from the use of quality measures for reimbursement issues in other federal health care laws to be used as standards of care in liability lawsuits.

Biosimilars

The president’s 2014 budget proposes to reduce the exclusivity for brand names from 12 years to 7 years beginning in 2014 and to prohibit "evergreening" – the securing of additional periods of exclusivity for brand biologics because of minor changes in product formulations.

Additionally, the Coalition of State Rheumatology Organizations is lobbying state legislatures to ensure that biosimilars legislation includes appropriate patient protections, such as physician notification of any substitution, appropriate record keeping, and "dispense as written" requirements. To date, five such bills have passed, with North Dakota, Utah, Virginia, and Oregon including all of these measures and Florida including all but notification.

Graduate medical education

Workforce shortages aren’t just a primary care issue. They also affect multiple specialties, including rheumatology. Though not unique in this regard, rheumatology is representative of an aging specialty, with more physicians reaching the end of their careers than young physicians entering the field. Coupled with the aging population, this raises concerns. The coalition and the Alliance of Specialty Medicine Policy Roundtable on Workforce sought cosponsors for H.R. 1180 and S. 577, the Resident Physician Shortage Reduction Act of 2013, and H.R. 1201, the Training Tomorrow’s Doctor Today Act. These legislative initiatives seek to address the problem of residency-slot shortages.

Dr. Schweitz reported having no disclosures.

rhnews@frontlinemedcom.com

LAS VEGAS – A coalition working to address dual-energy X-ray absorptiometry access issues is developing draft legislation that would establish a geographically adjusted national minimum payment for DXA, according to Dr. Michael Schweitz.

Under the draft legislation – a response to a series of reimbursement cuts over the past several years – DXA CPT codes 77080 and 77082 would be paid at $98 and $35, respectively, and a bundled code or bundled payment for bone density and vertebral fracture assessment studies would result in a national minimum payment of $133, Dr. Schweitz, president of the Coalition of State Rheumatology Organizations, said at Perspectives in Rheumatic Diseases 2013 during an update on federal legislative and regulatory issues facing rheumatologists.

Restoring reimbursement is an issue on the "front burner," he said, noting that studies have demonstrated an increase in hip fracture rates in the wake of declining reimbursement as some practices have abandoned DXA.

The DXA draft legislation is just one of a number of current legislative initiatives and issues that should be on rheumatologists’ radar, Dr. Schweitz said.

Sequestration

Under sequestration – a "heavy hammer" proposed as a way to push for agreement on a deficit-reduction plan and implemented when that agreement didn’t materialize – Medicare provider reductions are limited to 2% per year. Claims are reduced by 2% after beneficiary coinsurance or deductible. H.R. 1416, the Cancer Patient Protection Act of 2013, would terminate sequester cuts for all part B drugs, not just cancer drugs.

Medicare physician payment

Based on the formula for the Medicare sustainable growth rate, or SGR, physician payments will be cut by 24.4% if Congress does not intervene by Jan. 1, 2014. The latest cost estimate by the Congressional Budget Office for repeal of the SGR is $176 billion – far less than previous estimates and far less than the combined cost of prior short-term patches. President Barack Obama’s 2014 budget, as well as Congressional budgets and recent federal rulemakings, all assume that Congress will fix the SGR this year. Draft legislation released in July based on a replacement proposal from the bipartisan House Energy & Commerce Committee calls for a two-phase approach. Phase I would repeal the SGR entirely and replace it with a 5-year period of stable payments, including a 0.5% increase across-the-board, and phase II would involve implementation of an enhanced "PQRS-like Update Incentive Program." This would maintain fee-for-service as an option, allow providers to move into other models at any time, and would involve physician-driven quality measurement.

"This is something all of us should be aware of ... you can be sure that this whole system of reimbursement for what we do is going to change in the future," said Dr. Schweitz, who has a private practice in West Palm Beach, Fla.

How the changes would be paid for has not been defined, but there is a proposal from the House Ways & Means Committee that involves entitlement reform with increased part B/D deductibles and an increased age for eligibility.

Part B drug payments

A new bill (H.R. 800) that would affect physicians who provide in-office drug infusion excludes prompt pay discounts from manufacturers to wholesalers from the average sales price (ASP) calculation for part B drugs. This would improve payment for physicians who do not receive the discounts. However, the president’s 2014 budget assumes part B drugs are overpaid and proposes reducing Medicare payment from ASP plus 6% to ASP plus 3%.

This would require legislation to enact. The House and Senate budgets do not include any assumption regarding ASP.

"There’s very little chance, I think, that either side is going to be successful with this," Dr. Schweitz said.

The Independent Payment Advisory Board

The IPAB, a 15-member board created as part of the Affordable Care Act to make recommendations to cut spending when costs exceed growth targets, has been a contentious issue.

"There is a huge outcry in Congress against this IPAB," Dr. Schweitz said, explaining that there is a sense that the IPAB represents a usurping of the authority of Congress in controlling this part of Medicare activity.

A bipartisan repeal effort is underway in the form of H.R. 351/S. 351, the Protecting Seniors’ Access to Medicare Act. This has a chance of moving forward, but opposition in the Senate could hold it back, Dr. Schweitz said.

Of note, the president’s 2014 budget would lower the target rate that triggers IPAB recommendations from gross domestic product plus 1% to GDP plus 0.5%. Also, House Speaker John Boehner (R-Ohio) and Senate Minority Leader Mitch McConnell (R-Ky.) are on record saying that they will not nominate members to the IPAB, he said.

Private contracting

Private contracting is permitted under current law, but physicians who engage in it must opt out of Medicare for 2 years; patients who sign a private contract must pay out of pocket, even for services covered by Medicare. Under S. 236/H.R. 1310 – the Medicare Patient Empowerment Act – the 2-year opt-out requirement would be eliminated and beneficiaries could use their benefits to offset a portion of the fee set by their physician. This would protect low-income patients, "dual-eligibles," and patients with certain emergent or urgent health conditions. It is opposed by the Democratic Party and AARP, who see it as a cost-shifting mechanism; others feel it is a way to help reduce Medicare spending, he noted.

Medical liability reform

There’s been "a lot of noise but not much action" when it comes to medical liability reform, Dr. Schweitz said.

A House bill that would have included a $250,000 cap on noneconomic damages was paired with the IPAB repeal bill in the 112th Congress but did not make it to the Senate.

"There’s no such bill active in this [113th] Congress, but there are other kinds of liability reform acts that are more focused," he said.

These include H.R. 36/S. 961, the Health Care Safety Net Enhancement Act of 2013, which would extend Federal Tort Claims Act liability protections to on-call specialty physicians; H.R. 1733, the Good Samaritan Health Professionals Act of 2013, which would limit liability of health care professionals who volunteer to provide health care in response to a declared natural disaster; and H.R. 1473, the Standard of Care Protection Act, which would protect physicians from the use of quality measures for reimbursement issues in other federal health care laws to be used as standards of care in liability lawsuits.

Biosimilars

The president’s 2014 budget proposes to reduce the exclusivity for brand names from 12 years to 7 years beginning in 2014 and to prohibit "evergreening" – the securing of additional periods of exclusivity for brand biologics because of minor changes in product formulations.

Additionally, the Coalition of State Rheumatology Organizations is lobbying state legislatures to ensure that biosimilars legislation includes appropriate patient protections, such as physician notification of any substitution, appropriate record keeping, and "dispense as written" requirements. To date, five such bills have passed, with North Dakota, Utah, Virginia, and Oregon including all of these measures and Florida including all but notification.

Graduate medical education

Workforce shortages aren’t just a primary care issue. They also affect multiple specialties, including rheumatology. Though not unique in this regard, rheumatology is representative of an aging specialty, with more physicians reaching the end of their careers than young physicians entering the field. Coupled with the aging population, this raises concerns. The coalition and the Alliance of Specialty Medicine Policy Roundtable on Workforce sought cosponsors for H.R. 1180 and S. 577, the Resident Physician Shortage Reduction Act of 2013, and H.R. 1201, the Training Tomorrow’s Doctor Today Act. These legislative initiatives seek to address the problem of residency-slot shortages.

Dr. Schweitz reported having no disclosures.

rhnews@frontlinemedcom.com

LAS VEGAS – A coalition working to address dual-energy X-ray absorptiometry access issues is developing draft legislation that would establish a geographically adjusted national minimum payment for DXA, according to Dr. Michael Schweitz.

Under the draft legislation – a response to a series of reimbursement cuts over the past several years – DXA CPT codes 77080 and 77082 would be paid at $98 and $35, respectively, and a bundled code or bundled payment for bone density and vertebral fracture assessment studies would result in a national minimum payment of $133, Dr. Schweitz, president of the Coalition of State Rheumatology Organizations, said at Perspectives in Rheumatic Diseases 2013 during an update on federal legislative and regulatory issues facing rheumatologists.

Restoring reimbursement is an issue on the "front burner," he said, noting that studies have demonstrated an increase in hip fracture rates in the wake of declining reimbursement as some practices have abandoned DXA.

The DXA draft legislation is just one of a number of current legislative initiatives and issues that should be on rheumatologists’ radar, Dr. Schweitz said.

Sequestration

Under sequestration – a "heavy hammer" proposed as a way to push for agreement on a deficit-reduction plan and implemented when that agreement didn’t materialize – Medicare provider reductions are limited to 2% per year. Claims are reduced by 2% after beneficiary coinsurance or deductible. H.R. 1416, the Cancer Patient Protection Act of 2013, would terminate sequester cuts for all part B drugs, not just cancer drugs.

Medicare physician payment

Based on the formula for the Medicare sustainable growth rate, or SGR, physician payments will be cut by 24.4% if Congress does not intervene by Jan. 1, 2014. The latest cost estimate by the Congressional Budget Office for repeal of the SGR is $176 billion – far less than previous estimates and far less than the combined cost of prior short-term patches. President Barack Obama’s 2014 budget, as well as Congressional budgets and recent federal rulemakings, all assume that Congress will fix the SGR this year. Draft legislation released in July based on a replacement proposal from the bipartisan House Energy & Commerce Committee calls for a two-phase approach. Phase I would repeal the SGR entirely and replace it with a 5-year period of stable payments, including a 0.5% increase across-the-board, and phase II would involve implementation of an enhanced "PQRS-like Update Incentive Program." This would maintain fee-for-service as an option, allow providers to move into other models at any time, and would involve physician-driven quality measurement.

"This is something all of us should be aware of ... you can be sure that this whole system of reimbursement for what we do is going to change in the future," said Dr. Schweitz, who has a private practice in West Palm Beach, Fla.

How the changes would be paid for has not been defined, but there is a proposal from the House Ways & Means Committee that involves entitlement reform with increased part B/D deductibles and an increased age for eligibility.

Part B drug payments

A new bill (H.R. 800) that would affect physicians who provide in-office drug infusion excludes prompt pay discounts from manufacturers to wholesalers from the average sales price (ASP) calculation for part B drugs. This would improve payment for physicians who do not receive the discounts. However, the president’s 2014 budget assumes part B drugs are overpaid and proposes reducing Medicare payment from ASP plus 6% to ASP plus 3%.

This would require legislation to enact. The House and Senate budgets do not include any assumption regarding ASP.

"There’s very little chance, I think, that either side is going to be successful with this," Dr. Schweitz said.

The Independent Payment Advisory Board

The IPAB, a 15-member board created as part of the Affordable Care Act to make recommendations to cut spending when costs exceed growth targets, has been a contentious issue.

"There is a huge outcry in Congress against this IPAB," Dr. Schweitz said, explaining that there is a sense that the IPAB represents a usurping of the authority of Congress in controlling this part of Medicare activity.

A bipartisan repeal effort is underway in the form of H.R. 351/S. 351, the Protecting Seniors’ Access to Medicare Act. This has a chance of moving forward, but opposition in the Senate could hold it back, Dr. Schweitz said.

Of note, the president’s 2014 budget would lower the target rate that triggers IPAB recommendations from gross domestic product plus 1% to GDP plus 0.5%. Also, House Speaker John Boehner (R-Ohio) and Senate Minority Leader Mitch McConnell (R-Ky.) are on record saying that they will not nominate members to the IPAB, he said.

Private contracting

Private contracting is permitted under current law, but physicians who engage in it must opt out of Medicare for 2 years; patients who sign a private contract must pay out of pocket, even for services covered by Medicare. Under S. 236/H.R. 1310 – the Medicare Patient Empowerment Act – the 2-year opt-out requirement would be eliminated and beneficiaries could use their benefits to offset a portion of the fee set by their physician. This would protect low-income patients, "dual-eligibles," and patients with certain emergent or urgent health conditions. It is opposed by the Democratic Party and AARP, who see it as a cost-shifting mechanism; others feel it is a way to help reduce Medicare spending, he noted.

Medical liability reform

There’s been "a lot of noise but not much action" when it comes to medical liability reform, Dr. Schweitz said.

A House bill that would have included a $250,000 cap on noneconomic damages was paired with the IPAB repeal bill in the 112th Congress but did not make it to the Senate.

"There’s no such bill active in this [113th] Congress, but there are other kinds of liability reform acts that are more focused," he said.

These include H.R. 36/S. 961, the Health Care Safety Net Enhancement Act of 2013, which would extend Federal Tort Claims Act liability protections to on-call specialty physicians; H.R. 1733, the Good Samaritan Health Professionals Act of 2013, which would limit liability of health care professionals who volunteer to provide health care in response to a declared natural disaster; and H.R. 1473, the Standard of Care Protection Act, which would protect physicians from the use of quality measures for reimbursement issues in other federal health care laws to be used as standards of care in liability lawsuits.

Biosimilars

The president’s 2014 budget proposes to reduce the exclusivity for brand names from 12 years to 7 years beginning in 2014 and to prohibit "evergreening" – the securing of additional periods of exclusivity for brand biologics because of minor changes in product formulations.

Additionally, the Coalition of State Rheumatology Organizations is lobbying state legislatures to ensure that biosimilars legislation includes appropriate patient protections, such as physician notification of any substitution, appropriate record keeping, and "dispense as written" requirements. To date, five such bills have passed, with North Dakota, Utah, Virginia, and Oregon including all of these measures and Florida including all but notification.

Graduate medical education

Workforce shortages aren’t just a primary care issue. They also affect multiple specialties, including rheumatology. Though not unique in this regard, rheumatology is representative of an aging specialty, with more physicians reaching the end of their careers than young physicians entering the field. Coupled with the aging population, this raises concerns. The coalition and the Alliance of Specialty Medicine Policy Roundtable on Workforce sought cosponsors for H.R. 1180 and S. 577, the Resident Physician Shortage Reduction Act of 2013, and H.R. 1201, the Training Tomorrow’s Doctor Today Act. These legislative initiatives seek to address the problem of residency-slot shortages.

Dr. Schweitz reported having no disclosures.

rhnews@frontlinemedcom.com