Psoriasis

NEWPORT BEACH, CALIF. – The approval of apremilast (Otezla) for the treatment of moderate to severe plaque psoriasis will make a significant impact on patient care, Dr. Alan Menter of Baylor University Medical Center, Dallas, Tex., said at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

“I think where this drug is going to have a role is ... patients who are risk averse to needles, have contraindications to TNF-alpha agents ... patients who want a drug with minimal to no long-term side effects,” with the exception of the significant incidence of diarrhea within the early weeks of starting the drug, Dr. Menter explained. Clinicians should explain the risk of diarrhea to patients, and help them get through the first few months. The diarrhea “definitely does vanish with time,” he said. Overall, the risk of side effects is extremely low, he noted. “It is probably the safest drug we have approved for psoriasis today.”

SDEF and this news organization are owned by Frontline Medical Communications.

hsplete@frontlinemedcom.com

NEWPORT BEACH, CALIF. – The approval of apremilast (Otezla) for the treatment of moderate to severe plaque psoriasis will make a significant impact on patient care, Dr. Alan Menter of Baylor University Medical Center, Dallas, Tex., said at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

“I think where this drug is going to have a role is ... patients who are risk averse to needles, have contraindications to TNF-alpha agents ... patients who want a drug with minimal to no long-term side effects,” with the exception of the significant incidence of diarrhea within the early weeks of starting the drug, Dr. Menter explained. Clinicians should explain the risk of diarrhea to patients, and help them get through the first few months. The diarrhea “definitely does vanish with time,” he said. Overall, the risk of side effects is extremely low, he noted. “It is probably the safest drug we have approved for psoriasis today.”

SDEF and this news organization are owned by Frontline Medical Communications.

hsplete@frontlinemedcom.com

NEWPORT BEACH, CALIF. – The approval of apremilast (Otezla) for the treatment of moderate to severe plaque psoriasis will make a significant impact on patient care, Dr. Alan Menter of Baylor University Medical Center, Dallas, Tex., said at Skin Disease Education Foundation’s Women’s & Pediatric Dermatology Seminar.

“I think where this drug is going to have a role is ... patients who are risk averse to needles, have contraindications to TNF-alpha agents ... patients who want a drug with minimal to no long-term side effects,” with the exception of the significant incidence of diarrhea within the early weeks of starting the drug, Dr. Menter explained. Clinicians should explain the risk of diarrhea to patients, and help them get through the first few months. The diarrhea “definitely does vanish with time,” he said. Overall, the risk of side effects is extremely low, he noted. “It is probably the safest drug we have approved for psoriasis today.”

SDEF and this news organization are owned by Frontline Medical Communications.

hsplete@frontlinemedcom.com

Psoriatic dactylitis might be caused by inflammation of the small enthesis pulleys of flexor tendons of affected fingers and toes, according a study using high-resolution MRI.

The findings help explain the association between flexor tenosynovitis and dactylitis in patients with psoriatic arthritis (PsA), said Dr. Ai Lyn Tan of the National Institute for Health Research’s musculoskeletal biomedical research unit at Leeds (England) University.

Dactylitis, also known as sausage digits, affects about 40% of patients with PsA. Past studies have suggested that enthesitis might be the cause but also have found a link between dactylitis and flexor tenosynovitis, the researchers said. Using high-resolution MRI (hr-MRI), they obtained T1- and T2-weighted images and contrast-enhanced MRI of the digits of 12 patients, including 22 dactylic joints. The investigators also imaged 13 finger and toe joints from 10 healthy controls (Ann. Rheum. Dis. 2014 Sept. 26 [doi:10.1136/annrheumdis-2014-205839].

The hr-MRI studies showed that 75% of patients with dactylitis had enthesitis of the collateral ligament insertions of fingers or toes and 50% had enthesitis of the extensor tendon insertions. Three patients – two of whom had received intramuscular steroid injections within 6 weeks of the scan – did not have ligament enthesitis. Patients who had received steroid injections also lacked evidence of extensor tendon enthesitis. Furthermore, flexor tenosynovitis was seen in 75% of patients with dactylitis, the investigators reported.

Abnormalities were less frequent and milder among the healthy controls. None had signal changes in the tendon pulleys or fibrous sheaths, and only one had evidence of mild flexor tenosynovitis (P = .004), they said.

Limitations of the study included its small size, the researchers noted. In addition, nine patients were male and only three were female.

The study was funded by the Medical Research Council and Arthritis Research UK. The authors reported no conflicts of interest.

Psoriatic dactylitis might be caused by inflammation of the small enthesis pulleys of flexor tendons of affected fingers and toes, according a study using high-resolution MRI.

The findings help explain the association between flexor tenosynovitis and dactylitis in patients with psoriatic arthritis (PsA), said Dr. Ai Lyn Tan of the National Institute for Health Research’s musculoskeletal biomedical research unit at Leeds (England) University.

Dactylitis, also known as sausage digits, affects about 40% of patients with PsA. Past studies have suggested that enthesitis might be the cause but also have found a link between dactylitis and flexor tenosynovitis, the researchers said. Using high-resolution MRI (hr-MRI), they obtained T1- and T2-weighted images and contrast-enhanced MRI of the digits of 12 patients, including 22 dactylic joints. The investigators also imaged 13 finger and toe joints from 10 healthy controls (Ann. Rheum. Dis. 2014 Sept. 26 [doi:10.1136/annrheumdis-2014-205839].

The hr-MRI studies showed that 75% of patients with dactylitis had enthesitis of the collateral ligament insertions of fingers or toes and 50% had enthesitis of the extensor tendon insertions. Three patients – two of whom had received intramuscular steroid injections within 6 weeks of the scan – did not have ligament enthesitis. Patients who had received steroid injections also lacked evidence of extensor tendon enthesitis. Furthermore, flexor tenosynovitis was seen in 75% of patients with dactylitis, the investigators reported.

Abnormalities were less frequent and milder among the healthy controls. None had signal changes in the tendon pulleys or fibrous sheaths, and only one had evidence of mild flexor tenosynovitis (P = .004), they said.

Limitations of the study included its small size, the researchers noted. In addition, nine patients were male and only three were female.

The study was funded by the Medical Research Council and Arthritis Research UK. The authors reported no conflicts of interest.

Psoriatic dactylitis might be caused by inflammation of the small enthesis pulleys of flexor tendons of affected fingers and toes, according a study using high-resolution MRI.

The findings help explain the association between flexor tenosynovitis and dactylitis in patients with psoriatic arthritis (PsA), said Dr. Ai Lyn Tan of the National Institute for Health Research’s musculoskeletal biomedical research unit at Leeds (England) University.

Dactylitis, also known as sausage digits, affects about 40% of patients with PsA. Past studies have suggested that enthesitis might be the cause but also have found a link between dactylitis and flexor tenosynovitis, the researchers said. Using high-resolution MRI (hr-MRI), they obtained T1- and T2-weighted images and contrast-enhanced MRI of the digits of 12 patients, including 22 dactylic joints. The investigators also imaged 13 finger and toe joints from 10 healthy controls (Ann. Rheum. Dis. 2014 Sept. 26 [doi:10.1136/annrheumdis-2014-205839].

The hr-MRI studies showed that 75% of patients with dactylitis had enthesitis of the collateral ligament insertions of fingers or toes and 50% had enthesitis of the extensor tendon insertions. Three patients – two of whom had received intramuscular steroid injections within 6 weeks of the scan – did not have ligament enthesitis. Patients who had received steroid injections also lacked evidence of extensor tendon enthesitis. Furthermore, flexor tenosynovitis was seen in 75% of patients with dactylitis, the investigators reported.

Abnormalities were less frequent and milder among the healthy controls. None had signal changes in the tendon pulleys or fibrous sheaths, and only one had evidence of mild flexor tenosynovitis (P = .004), they said.

Limitations of the study included its small size, the researchers noted. In addition, nine patients were male and only three were female.

The study was funded by the Medical Research Council and Arthritis Research UK. The authors reported no conflicts of interest.

Combining tumor necrosis factor-alpha inhibitors with conventional disease-modifying antirheumatic drugs more than doubled the risk of shingles in patients with psoriatic arthritis, according to a retrospective cohort study.

Patients who took drugs from only one class or the other, however, were no more likely to develop herpes zoster than were untreated patients, said Dr. Devy Zisman of Carmel Medical Center in Haifa, Israel, and his associates.

Biological therapies for inflammatory arthritis have been linked to an increased risk of herpes zoster in some analyses. To investigate the issue, Dr. Zisman and associates studied 3,128 patients with psoriatic arthritis from a national Israeli health care database. The patients averaged 50 years of age, and 46% were male (Ann. Rheum. Dis. 2014 Sept. 26 [doi:10.1136/ annrheumdis-2013-205148]).

© clsgraphics/iStockphoto.com

A total of 182 herpes zoster cases occurred during 20,096 person-years of observation, the researchers said. After controlling for sex, age, comorbidities, steroid treatment, and past treatment with conventional DMARDs, the hazard ratio for herpes zoster with coadministration of tumor necrosis factor-alpha (TNF-alpha) inhibitors and conventional DMARDs was 2.37 (95% confidence interval, 1.32-4.22; P = .004), compared with 1.28 for TNF-alpha inhibitors alone (95% CI, 0.69-2.4) and 1.11 for conventional DMARDs alone (95% CI, 0.76-1.62). The anti–TNF-alpha agents studied included infliximab, adalimumab, and etanercept, while DMARDs included salazopyrine, methotrexate, leflunomide, cyclosporine A, azathioprine, and hydroxychloroquine.

The incidence of herpes zoster in patients prescribed combination regimens was 17.86 cases per 1,000 person-years (95% CI, 10.91-27.58), far higher than for patients who took neither DMARDs nor anti–TNF-alpha agents (7.36), took only conventional DMARDs (9.21), or took only TNF-alpha inhibitors (8.64), the investigators reported.

Older age and treatment with steroids were linked to a slight rise in the risk of herpes zoster (HRs, 1.01 and 1.08, respectively), confirming prior findings, Dr. Zisman and his associates said.

The authors reported no funding sources or conflicts of interest.

Combining tumor necrosis factor-alpha inhibitors with conventional disease-modifying antirheumatic drugs more than doubled the risk of shingles in patients with psoriatic arthritis, according to a retrospective cohort study.

Patients who took drugs from only one class or the other, however, were no more likely to develop herpes zoster than were untreated patients, said Dr. Devy Zisman of Carmel Medical Center in Haifa, Israel, and his associates.

Biological therapies for inflammatory arthritis have been linked to an increased risk of herpes zoster in some analyses. To investigate the issue, Dr. Zisman and associates studied 3,128 patients with psoriatic arthritis from a national Israeli health care database. The patients averaged 50 years of age, and 46% were male (Ann. Rheum. Dis. 2014 Sept. 26 [doi:10.1136/ annrheumdis-2013-205148]).

© clsgraphics/iStockphoto.com

A total of 182 herpes zoster cases occurred during 20,096 person-years of observation, the researchers said. After controlling for sex, age, comorbidities, steroid treatment, and past treatment with conventional DMARDs, the hazard ratio for herpes zoster with coadministration of tumor necrosis factor-alpha (TNF-alpha) inhibitors and conventional DMARDs was 2.37 (95% confidence interval, 1.32-4.22; P = .004), compared with 1.28 for TNF-alpha inhibitors alone (95% CI, 0.69-2.4) and 1.11 for conventional DMARDs alone (95% CI, 0.76-1.62). The anti–TNF-alpha agents studied included infliximab, adalimumab, and etanercept, while DMARDs included salazopyrine, methotrexate, leflunomide, cyclosporine A, azathioprine, and hydroxychloroquine.

The incidence of herpes zoster in patients prescribed combination regimens was 17.86 cases per 1,000 person-years (95% CI, 10.91-27.58), far higher than for patients who took neither DMARDs nor anti–TNF-alpha agents (7.36), took only conventional DMARDs (9.21), or took only TNF-alpha inhibitors (8.64), the investigators reported.

Older age and treatment with steroids were linked to a slight rise in the risk of herpes zoster (HRs, 1.01 and 1.08, respectively), confirming prior findings, Dr. Zisman and his associates said.

The authors reported no funding sources or conflicts of interest.

Combining tumor necrosis factor-alpha inhibitors with conventional disease-modifying antirheumatic drugs more than doubled the risk of shingles in patients with psoriatic arthritis, according to a retrospective cohort study.

Patients who took drugs from only one class or the other, however, were no more likely to develop herpes zoster than were untreated patients, said Dr. Devy Zisman of Carmel Medical Center in Haifa, Israel, and his associates.

Biological therapies for inflammatory arthritis have been linked to an increased risk of herpes zoster in some analyses. To investigate the issue, Dr. Zisman and associates studied 3,128 patients with psoriatic arthritis from a national Israeli health care database. The patients averaged 50 years of age, and 46% were male (Ann. Rheum. Dis. 2014 Sept. 26 [doi:10.1136/ annrheumdis-2013-205148]).

© clsgraphics/iStockphoto.com

A total of 182 herpes zoster cases occurred during 20,096 person-years of observation, the researchers said. After controlling for sex, age, comorbidities, steroid treatment, and past treatment with conventional DMARDs, the hazard ratio for herpes zoster with coadministration of tumor necrosis factor-alpha (TNF-alpha) inhibitors and conventional DMARDs was 2.37 (95% confidence interval, 1.32-4.22; P = .004), compared with 1.28 for TNF-alpha inhibitors alone (95% CI, 0.69-2.4) and 1.11 for conventional DMARDs alone (95% CI, 0.76-1.62). The anti–TNF-alpha agents studied included infliximab, adalimumab, and etanercept, while DMARDs included salazopyrine, methotrexate, leflunomide, cyclosporine A, azathioprine, and hydroxychloroquine.

The incidence of herpes zoster in patients prescribed combination regimens was 17.86 cases per 1,000 person-years (95% CI, 10.91-27.58), far higher than for patients who took neither DMARDs nor anti–TNF-alpha agents (7.36), took only conventional DMARDs (9.21), or took only TNF-alpha inhibitors (8.64), the investigators reported.

Older age and treatment with steroids were linked to a slight rise in the risk of herpes zoster (HRs, 1.01 and 1.08, respectively), confirming prior findings, Dr. Zisman and his associates said.

The authors reported no funding sources or conflicts of interest.

SONOMA, CALIF. – Concerns about the risk of developing deep fungal infections in patients on biologic therapies for psoriasis are real, but not as significant as some may think, Dr. Miriam S. Bettencourt said at the annual Coastal Dermatology Symposium.

Data suggest that 98% of all patients who developed deep fungal infection while taking a biologic drug also were taking another immunosuppressant, usually prednisone, said Dr. Bettencourt of the University of Nevada, Las Vegas.

Among a subgroup of patients taking a biologic drug for psoriasis or psoriatic arthritis, the risk of developing a deep fungal infection is significantly lower than among all patients on biologics, she said at the symposium, jointly presented by the University of Louisville (Ky.) and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.

Dr. Bettencourt reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SONOMA, CALIF. – Concerns about the risk of developing deep fungal infections in patients on biologic therapies for psoriasis are real, but not as significant as some may think, Dr. Miriam S. Bettencourt said at the annual Coastal Dermatology Symposium.

Data suggest that 98% of all patients who developed deep fungal infection while taking a biologic drug also were taking another immunosuppressant, usually prednisone, said Dr. Bettencourt of the University of Nevada, Las Vegas.

Among a subgroup of patients taking a biologic drug for psoriasis or psoriatic arthritis, the risk of developing a deep fungal infection is significantly lower than among all patients on biologics, she said at the symposium, jointly presented by the University of Louisville (Ky.) and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.

Dr. Bettencourt reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

SONOMA, CALIF. – Concerns about the risk of developing deep fungal infections in patients on biologic therapies for psoriasis are real, but not as significant as some may think, Dr. Miriam S. Bettencourt said at the annual Coastal Dermatology Symposium.

Data suggest that 98% of all patients who developed deep fungal infection while taking a biologic drug also were taking another immunosuppressant, usually prednisone, said Dr. Bettencourt of the University of Nevada, Las Vegas.

Among a subgroup of patients taking a biologic drug for psoriasis or psoriatic arthritis, the risk of developing a deep fungal infection is significantly lower than among all patients on biologics, she said at the symposium, jointly presented by the University of Louisville (Ky.) and Global Academy for Medical Education. This publication and Global Academy for Medical Education are owned by the same parent company.

Dr. Bettencourt reported having no financial disclosures.

sboschert@frontlinemedcom.com

On Twitter @sherryboschert

While the availability of coupons can help defray out-of-pocket costs and improve access and adherence to high-cost specialty drugs, it may also result in higher costs to the health system.

Patients used drug coupons to pay for $21.2 million of $35.3 million in out-of-pocket costs, according to an analysis of 265,000 prescriptions worth $911 million in 2013. The coupons generally dropped a patient’s out-of-pocket costs to less than $250 per prescription, a point below which patients were “far less likely” to abandon prescriptions in cases of specialty anti-inflammatory drugs and treatments for multiple sclerosis (Health Affairs 2014;33:1761-9 [doi:10.1377/hlthaff.2014.0497]).

But while the use of coupons demonstrated that the lower cost led to lower prescription abandonment rates, it also allowed patients to circumvent cost-containment measures that pharmacy benefit managers employ.

© Photodisc / ThinkStockPhotos.com

“We found that drug coupons were extremely effective in lowering patients’ costs to less than $50 per prescription, thus eliminating the incentive to select a preferred drug,” wrote Catherine I. Starner, Pharm.D., senior health outcomes researcher at pharmacy benefit manager Prime Therapeutics, and her colleagues.

To control costs at the health system level, tighter controls could be placed on specialty drugs at the pharmacy benefit manager level, according to Dr. Starner and her colleagues. Such controls could include prior authorization or the use of step therapies,as well as excluding coverage of nonpreferred drugs. The latter strategy, however, could make drug access a problem, especially if physicians are not aware of an insurance plan taking these steps.

Excluding specialty drugs “makes the patient responsible for the entire cost of the drug,” the authors noted. “If prescribers are unaware of such exclusions, or if patients require specific therapies, such exclusions may impose considerable costs on patients” and potentially lead to access issues.

gtwachtman@frontlinemedcom.com

While the availability of coupons can help defray out-of-pocket costs and improve access and adherence to high-cost specialty drugs, it may also result in higher costs to the health system.

Patients used drug coupons to pay for $21.2 million of $35.3 million in out-of-pocket costs, according to an analysis of 265,000 prescriptions worth $911 million in 2013. The coupons generally dropped a patient’s out-of-pocket costs to less than $250 per prescription, a point below which patients were “far less likely” to abandon prescriptions in cases of specialty anti-inflammatory drugs and treatments for multiple sclerosis (Health Affairs 2014;33:1761-9 [doi:10.1377/hlthaff.2014.0497]).

But while the use of coupons demonstrated that the lower cost led to lower prescription abandonment rates, it also allowed patients to circumvent cost-containment measures that pharmacy benefit managers employ.

© Photodisc / ThinkStockPhotos.com

“We found that drug coupons were extremely effective in lowering patients’ costs to less than $50 per prescription, thus eliminating the incentive to select a preferred drug,” wrote Catherine I. Starner, Pharm.D., senior health outcomes researcher at pharmacy benefit manager Prime Therapeutics, and her colleagues.

To control costs at the health system level, tighter controls could be placed on specialty drugs at the pharmacy benefit manager level, according to Dr. Starner and her colleagues. Such controls could include prior authorization or the use of step therapies,as well as excluding coverage of nonpreferred drugs. The latter strategy, however, could make drug access a problem, especially if physicians are not aware of an insurance plan taking these steps.

Excluding specialty drugs “makes the patient responsible for the entire cost of the drug,” the authors noted. “If prescribers are unaware of such exclusions, or if patients require specific therapies, such exclusions may impose considerable costs on patients” and potentially lead to access issues.

gtwachtman@frontlinemedcom.com

While the availability of coupons can help defray out-of-pocket costs and improve access and adherence to high-cost specialty drugs, it may also result in higher costs to the health system.

Patients used drug coupons to pay for $21.2 million of $35.3 million in out-of-pocket costs, according to an analysis of 265,000 prescriptions worth $911 million in 2013. The coupons generally dropped a patient’s out-of-pocket costs to less than $250 per prescription, a point below which patients were “far less likely” to abandon prescriptions in cases of specialty anti-inflammatory drugs and treatments for multiple sclerosis (Health Affairs 2014;33:1761-9 [doi:10.1377/hlthaff.2014.0497]).

But while the use of coupons demonstrated that the lower cost led to lower prescription abandonment rates, it also allowed patients to circumvent cost-containment measures that pharmacy benefit managers employ.

© Photodisc / ThinkStockPhotos.com

“We found that drug coupons were extremely effective in lowering patients’ costs to less than $50 per prescription, thus eliminating the incentive to select a preferred drug,” wrote Catherine I. Starner, Pharm.D., senior health outcomes researcher at pharmacy benefit manager Prime Therapeutics, and her colleagues.

To control costs at the health system level, tighter controls could be placed on specialty drugs at the pharmacy benefit manager level, according to Dr. Starner and her colleagues. Such controls could include prior authorization or the use of step therapies,as well as excluding coverage of nonpreferred drugs. The latter strategy, however, could make drug access a problem, especially if physicians are not aware of an insurance plan taking these steps.

Excluding specialty drugs “makes the patient responsible for the entire cost of the drug,” the authors noted. “If prescribers are unaware of such exclusions, or if patients require specific therapies, such exclusions may impose considerable costs on patients” and potentially lead to access issues.

gtwachtman@frontlinemedcom.com

We are always conscious of the use of systemic medications in older patients, as they may have the potential for more toxicity. For dermatologists, use of systemic medications in psoriasis represents a large share of our total use. Theoretically, we are concerned that older patients may be more likely to develop serious infections and malignancies. Older psoriasis patients also represent a growing demographic, and they are underrepresented in clinical trials.

In an article published online on September 3, 2014, in the Journal of the European Academy of Dermatology and Venereology, Medina et al performed an analysis to evaluate the safety of systemic psoriasis therapy in patients older than 65 years compared to younger patients. Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were divided into 2 categories: elderly (≥65 years) and younger patients (<65 years). Rates of adverse events (AEs) were described by severity and type. The risks were compared in both groups, taking into account exposure to classic or biologic drugs using Cox regression.

In the overall study population, 175 (9.8%) of 1793 patients were elderly. The authors found that overall risk for AEs was not higher in elderly patients; the drug group–adjusted hazard ratio (HR) was 1.09 (95% confidence interval [CI], 0.93-1.3). However, serious AEs were more common in older patients, with a drug group–adjusted HR of 3.2 (95% CI, 2.0-5.1). Age-adjusted HR of all AEs was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR, 0.7 [95% CI, 0.6-0.7]). Age did not seem to modify the effect of therapy (biologic vs classic) in the risk for AEs (likelihood ratio test for interaction: P=.12 for all AEs; P=.09 for serious AEs).

The authors concluded that serious AEs were more common in elderly patients. They argued, however, that these serious AEs might be related to other factors associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk for AEs in the whole group. There were no differences in this association between young and old. These results are reassuring, though uncontrolled confounding could not be excluded as an explanation for these findings. The power of the study to detect differences was low.

What’s the issue?

The results indicate that overall there is no increase in AEs in older patients. More data will need to be evaluated to see if the incidence of serious AEs is due to medication use or endogenous health factors. How do you approach the use of systemic medications in older patients?

We want to know your views! Tell us what you think.

We are always conscious of the use of systemic medications in older patients, as they may have the potential for more toxicity. For dermatologists, use of systemic medications in psoriasis represents a large share of our total use. Theoretically, we are concerned that older patients may be more likely to develop serious infections and malignancies. Older psoriasis patients also represent a growing demographic, and they are underrepresented in clinical trials.

In an article published online on September 3, 2014, in the Journal of the European Academy of Dermatology and Venereology, Medina et al performed an analysis to evaluate the safety of systemic psoriasis therapy in patients older than 65 years compared to younger patients. Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were divided into 2 categories: elderly (≥65 years) and younger patients (<65 years). Rates of adverse events (AEs) were described by severity and type. The risks were compared in both groups, taking into account exposure to classic or biologic drugs using Cox regression.

In the overall study population, 175 (9.8%) of 1793 patients were elderly. The authors found that overall risk for AEs was not higher in elderly patients; the drug group–adjusted hazard ratio (HR) was 1.09 (95% confidence interval [CI], 0.93-1.3). However, serious AEs were more common in older patients, with a drug group–adjusted HR of 3.2 (95% CI, 2.0-5.1). Age-adjusted HR of all AEs was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR, 0.7 [95% CI, 0.6-0.7]). Age did not seem to modify the effect of therapy (biologic vs classic) in the risk for AEs (likelihood ratio test for interaction: P=.12 for all AEs; P=.09 for serious AEs).

The authors concluded that serious AEs were more common in elderly patients. They argued, however, that these serious AEs might be related to other factors associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk for AEs in the whole group. There were no differences in this association between young and old. These results are reassuring, though uncontrolled confounding could not be excluded as an explanation for these findings. The power of the study to detect differences was low.

What’s the issue?

The results indicate that overall there is no increase in AEs in older patients. More data will need to be evaluated to see if the incidence of serious AEs is due to medication use or endogenous health factors. How do you approach the use of systemic medications in older patients?

We want to know your views! Tell us what you think.

We are always conscious of the use of systemic medications in older patients, as they may have the potential for more toxicity. For dermatologists, use of systemic medications in psoriasis represents a large share of our total use. Theoretically, we are concerned that older patients may be more likely to develop serious infections and malignancies. Older psoriasis patients also represent a growing demographic, and they are underrepresented in clinical trials.

In an article published online on September 3, 2014, in the Journal of the European Academy of Dermatology and Venereology, Medina et al performed an analysis to evaluate the safety of systemic psoriasis therapy in patients older than 65 years compared to younger patients. Patients registered in Biobadaderm, a Spanish national registry of psoriasis patients treated with systemic therapy, were divided into 2 categories: elderly (≥65 years) and younger patients (<65 years). Rates of adverse events (AEs) were described by severity and type. The risks were compared in both groups, taking into account exposure to classic or biologic drugs using Cox regression.

In the overall study population, 175 (9.8%) of 1793 patients were elderly. The authors found that overall risk for AEs was not higher in elderly patients; the drug group–adjusted hazard ratio (HR) was 1.09 (95% confidence interval [CI], 0.93-1.3). However, serious AEs were more common in older patients, with a drug group–adjusted HR of 3.2 (95% CI, 2.0-5.1). Age-adjusted HR of all AEs was lower for patients exposed to biologics compared to classic drugs in the whole sample (HR, 0.7 [95% CI, 0.6-0.7]). Age did not seem to modify the effect of therapy (biologic vs classic) in the risk for AEs (likelihood ratio test for interaction: P=.12 for all AEs; P=.09 for serious AEs).

The authors concluded that serious AEs were more common in elderly patients. They argued, however, that these serious AEs might be related to other factors associated with this age group and not due to the treatment itself. Use of biologics was associated with lower risk for AEs in the whole group. There were no differences in this association between young and old. These results are reassuring, though uncontrolled confounding could not be excluded as an explanation for these findings. The power of the study to detect differences was low.

What’s the issue?

The results indicate that overall there is no increase in AEs in older patients. More data will need to be evaluated to see if the incidence of serious AEs is due to medication use or endogenous health factors. How do you approach the use of systemic medications in older patients?

We want to know your views! Tell us what you think.

For more information, access Dr. Weinberg's editorial from the September 2014 issue, "Under Pressure."

For more information, access Dr. Weinberg's editorial from the September 2014 issue, "Under Pressure."

For more information, access Dr. Weinberg's editorial from the September 2014 issue, "Under Pressure."

The oral phosphodiesterase-4 inhibitor apremilast is now indicated for the treatment of moderate to severe plaque psoriasis.

On Sept. 23, the manufacturer, Celgene, announced that the Food and Drug Administration had approved the expanded indication for apremilast, which was initially approved in March 2014 for treating psoriatic arthritis. The new indication is for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Approval was primarily based on the results of two multicenter, randomized, double-blind, placebo-controlled studies of adults with moderate to severe plaque psoriasis, according to Celgene. At 16 weeks, 33% and 29% of those randomized to the 30-mg, twice daily dose of apremilast had achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), compared with 5%-6% of those on placebo, according to the prescribing information.

The most common adverse events reported in studies, which affected at least 1% of treated patients and were more common than in patients on placebo, included diarrhea in 17% and nausea in 17%; other adverse events included upper respiratory infection, tension headache, and headache. The warnings and precautions section of the label includes the recommendation to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes in patients treated with the drug, and to monitor weight regularly for significant weight loss. In studies, treatment with apremilast has been associated with an increase in reports of depression and significant weight loss.

Celgene markets apremilast as Otezla.

Serious adverse events associated with treatment should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

Information about the pregnancy registry of women exposed to the drug during pregnancy can be obtained at 877-311-8972.

The updated prescribing information is available at http://www.celgene.com/content/uploads/2014/09/psoriasis-pi.pdf

emechcatie@frontlinemedcom.com

The oral phosphodiesterase-4 inhibitor apremilast is now indicated for the treatment of moderate to severe plaque psoriasis.

On Sept. 23, the manufacturer, Celgene, announced that the Food and Drug Administration had approved the expanded indication for apremilast, which was initially approved in March 2014 for treating psoriatic arthritis. The new indication is for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Approval was primarily based on the results of two multicenter, randomized, double-blind, placebo-controlled studies of adults with moderate to severe plaque psoriasis, according to Celgene. At 16 weeks, 33% and 29% of those randomized to the 30-mg, twice daily dose of apremilast had achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), compared with 5%-6% of those on placebo, according to the prescribing information.

The most common adverse events reported in studies, which affected at least 1% of treated patients and were more common than in patients on placebo, included diarrhea in 17% and nausea in 17%; other adverse events included upper respiratory infection, tension headache, and headache. The warnings and precautions section of the label includes the recommendation to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes in patients treated with the drug, and to monitor weight regularly for significant weight loss. In studies, treatment with apremilast has been associated with an increase in reports of depression and significant weight loss.

Celgene markets apremilast as Otezla.

Serious adverse events associated with treatment should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

Information about the pregnancy registry of women exposed to the drug during pregnancy can be obtained at 877-311-8972.

The updated prescribing information is available at http://www.celgene.com/content/uploads/2014/09/psoriasis-pi.pdf

emechcatie@frontlinemedcom.com

The oral phosphodiesterase-4 inhibitor apremilast is now indicated for the treatment of moderate to severe plaque psoriasis.

On Sept. 23, the manufacturer, Celgene, announced that the Food and Drug Administration had approved the expanded indication for apremilast, which was initially approved in March 2014 for treating psoriatic arthritis. The new indication is for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Approval was primarily based on the results of two multicenter, randomized, double-blind, placebo-controlled studies of adults with moderate to severe plaque psoriasis, according to Celgene. At 16 weeks, 33% and 29% of those randomized to the 30-mg, twice daily dose of apremilast had achieved at least a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), compared with 5%-6% of those on placebo, according to the prescribing information.

The most common adverse events reported in studies, which affected at least 1% of treated patients and were more common than in patients on placebo, included diarrhea in 17% and nausea in 17%; other adverse events included upper respiratory infection, tension headache, and headache. The warnings and precautions section of the label includes the recommendation to be alert for the emergence or worsening of depression, suicidal thoughts, or other mood changes in patients treated with the drug, and to monitor weight regularly for significant weight loss. In studies, treatment with apremilast has been associated with an increase in reports of depression and significant weight loss.

Celgene markets apremilast as Otezla.

Serious adverse events associated with treatment should be reported to the FDA at 800-332-1088 or www.fda.gov/medwatch.

Information about the pregnancy registry of women exposed to the drug during pregnancy can be obtained at 877-311-8972.

The updated prescribing information is available at http://www.celgene.com/content/uploads/2014/09/psoriasis-pi.pdf

emechcatie@frontlinemedcom.com

Therapies for Palmoplantar Pustular Psoriasis

There is limited evidence on therapies for palmoplantar pustular psoriasis (PPPP) and maintaining long-term remission. Sevrain et al (J Eur Acad Dermatol Venereol. 2014;28[suppl 5]:13-16) conducted a systematic literature search to identify trials in patients with PPPP that assessed therapeutic interventions (not including systemic biotherapy). They found that oral retinoid therapy (acitretin), photochemotherapy, or a combination of both; low-dose cyclosporine; or topical corticosteroids under occlusion appeared to help relieve symptoms of PPPP. Newer studies have noted the benefits of psoralen plus UVA, with better efficacy compared to UVB therapy. A 308-nm excimer laser has been shown to improve PPPP.

Practice Point: Although phototherapy, cyclosporine, and topical corticosteroids seem to be able to control PPPP, more randomized controlled trials are needed to better define treatment strategies for PPPP.

>>Read more at Journal of the European Academy of Dermatology and Venereology

Pediatric Pustular Psoriasis Cleared With Systemic Medications

Treatment of pediatric pustular psoriasis is challenging. Posso-De Los Rios and colleagues (Pediatr Dermatol. 2014;31:430-439) conducted a systematic review of systemic interventions for pediatric pustular psoriasis with a focus on clinical response and treatment outcomes. The most common therapies used for generalized pustular psoriasis were acitretin, cyclosporine, and methotrexate.

Practice Point: Acitretin, methotrexate, and cyclosporine seem to control generalized pustular psoriasis in the pediatric population; however, long-term data are lacking and physicians may encounter disease regression after discontinuing or tapering the medications.

>>Read more at Pediatric Dermatology

Biologics for Erythrodermic and Pustular Psoriasis

Levin et al (J Drugs Dermatol. 2014;13:342-354) sought to evaluate the efficacy and safety of biologics in the treatment of erythrodermic and generalized pustular psoriasis by reviewing the literature. In both psoriasis subtypes, infliximab was used to treat more than half of the reported cases. Other biologics that were successfully used included etanercept, ustekinumab, adalimumab, and anakinra.

Practice Point: Patients with erythrodermic or generalized pustular psoriasis may experience disease improvement with biologics.

>>Read more at Journal of Drugs in Dermatology

Therapies for Palmoplantar Pustular Psoriasis

There is limited evidence on therapies for palmoplantar pustular psoriasis (PPPP) and maintaining long-term remission. Sevrain et al (J Eur Acad Dermatol Venereol. 2014;28[suppl 5]:13-16) conducted a systematic literature search to identify trials in patients with PPPP that assessed therapeutic interventions (not including systemic biotherapy). They found that oral retinoid therapy (acitretin), photochemotherapy, or a combination of both; low-dose cyclosporine; or topical corticosteroids under occlusion appeared to help relieve symptoms of PPPP. Newer studies have noted the benefits of psoralen plus UVA, with better efficacy compared to UVB therapy. A 308-nm excimer laser has been shown to improve PPPP.

Practice Point: Although phototherapy, cyclosporine, and topical corticosteroids seem to be able to control PPPP, more randomized controlled trials are needed to better define treatment strategies for PPPP.

>>Read more at Journal of the European Academy of Dermatology and Venereology

Pediatric Pustular Psoriasis Cleared With Systemic Medications

Treatment of pediatric pustular psoriasis is challenging. Posso-De Los Rios and colleagues (Pediatr Dermatol. 2014;31:430-439) conducted a systematic review of systemic interventions for pediatric pustular psoriasis with a focus on clinical response and treatment outcomes. The most common therapies used for generalized pustular psoriasis were acitretin, cyclosporine, and methotrexate.

Practice Point: Acitretin, methotrexate, and cyclosporine seem to control generalized pustular psoriasis in the pediatric population; however, long-term data are lacking and physicians may encounter disease regression after discontinuing or tapering the medications.

>>Read more at Pediatric Dermatology

Biologics for Erythrodermic and Pustular Psoriasis

Levin et al (J Drugs Dermatol. 2014;13:342-354) sought to evaluate the efficacy and safety of biologics in the treatment of erythrodermic and generalized pustular psoriasis by reviewing the literature. In both psoriasis subtypes, infliximab was used to treat more than half of the reported cases. Other biologics that were successfully used included etanercept, ustekinumab, adalimumab, and anakinra.

Practice Point: Patients with erythrodermic or generalized pustular psoriasis may experience disease improvement with biologics.

>>Read more at Journal of Drugs in Dermatology

Therapies for Palmoplantar Pustular Psoriasis

There is limited evidence on therapies for palmoplantar pustular psoriasis (PPPP) and maintaining long-term remission. Sevrain et al (J Eur Acad Dermatol Venereol. 2014;28[suppl 5]:13-16) conducted a systematic literature search to identify trials in patients with PPPP that assessed therapeutic interventions (not including systemic biotherapy). They found that oral retinoid therapy (acitretin), photochemotherapy, or a combination of both; low-dose cyclosporine; or topical corticosteroids under occlusion appeared to help relieve symptoms of PPPP. Newer studies have noted the benefits of psoralen plus UVA, with better efficacy compared to UVB therapy. A 308-nm excimer laser has been shown to improve PPPP.

Practice Point: Although phototherapy, cyclosporine, and topical corticosteroids seem to be able to control PPPP, more randomized controlled trials are needed to better define treatment strategies for PPPP.

>>Read more at Journal of the European Academy of Dermatology and Venereology

Pediatric Pustular Psoriasis Cleared With Systemic Medications

Treatment of pediatric pustular psoriasis is challenging. Posso-De Los Rios and colleagues (Pediatr Dermatol. 2014;31:430-439) conducted a systematic review of systemic interventions for pediatric pustular psoriasis with a focus on clinical response and treatment outcomes. The most common therapies used for generalized pustular psoriasis were acitretin, cyclosporine, and methotrexate.

Practice Point: Acitretin, methotrexate, and cyclosporine seem to control generalized pustular psoriasis in the pediatric population; however, long-term data are lacking and physicians may encounter disease regression after discontinuing or tapering the medications.

>>Read more at Pediatric Dermatology

Biologics for Erythrodermic and Pustular Psoriasis

Levin et al (J Drugs Dermatol. 2014;13:342-354) sought to evaluate the efficacy and safety of biologics in the treatment of erythrodermic and generalized pustular psoriasis by reviewing the literature. In both psoriasis subtypes, infliximab was used to treat more than half of the reported cases. Other biologics that were successfully used included etanercept, ustekinumab, adalimumab, and anakinra.

Practice Point: Patients with erythrodermic or generalized pustular psoriasis may experience disease improvement with biologics.

>>Read more at Journal of Drugs in Dermatology

LAS VEGAS – A number of drugs are showing promise for the treatment of psoriatic arthritis, but broader improvements are needed with respect to treatment strategies, according to Dr. Iain McInnes.

Earlier diagnosis, appropriate therapies, and treating to target are among the topics he covered in a presentation on maximizing patient outcomes at the annual Perspectives in Rheumatic Diseases.

A recent study demonstrated that even a 6-month delay in the diagnosis of psoriatic arthritis is associated with worse long-term outcomes on several measures. In that study of 283 patients (Ann. Rheum. Dis. 2014 Feb. 13 [doi: 10.1136/annrheumdis-2013-204858]), the median lag time from disease onset to first rheumatological assessment was 1 year, with only 30% of patients being seen by a rheumatologist within 6 months.

Multiple stepwise regression analysis showed that late consulters had a greater risk of developing peripheral joint erosions (odds ratio, 4.25) and had worse Health Assessment Questionnaire scores (odds ratio, 2.2).

One finding that could help with earlier diagnosis is detection of early entheseal involvement, said Dr. McInnes, professor of medicine and director of the Institute of Infection, Immunity and Immunology at the University of Glasgow (Scotland).

Subclinical entheseal involvement appears to predict psoriatic arthritis in patients presenting with psoriasis, he said at the conference.

In one study, the mean Glasgow Ultrasound Enthesitis Scoring System (GUESS) score was 7.9 in patients with psoriasis, compared with 2.9 in controls, and in another study, thickness of the quadriceps tendon was a significant predictor of the development of psoriatic arthritis in those with psoriasis.

A key challenge in maximizing outcomes in psoriatic arthritis is that rheumatoid arthritis and psoriatic arthritis are typically treated as homogeneous for the purposes of drug development, but the two diseases have distinct clinical phenotypes and time course, tissue distribution, tissue cell/molecular features, genetic susceptibility, and probably impact of immune senescence.

In fact, while disease-modifying antirheumatic drugs are included in European League Against Rheumatsm (EULAR) treatment guidelines for psoriatic arthritis, the Methotrexate in Psoriatic Arthritis (MIPA) trial, a 6-month, double-blind, randomized, placebo-controlled trial of methotrexate, showed no benefit for key psoriatic arthritis endpoints at 3 and 6 months (Rheumatology 2012;51:1368-77).

Data on methotrexate combination therapy is limited, but existing clinical trials and registry data show no clear evidence of benefit. Methotrexate also has long-term toxicity issues.

In studies of patients who received anti–tumor necrosis factor therapy, 59%-69% of patients achieved 20% improvement (ACR 20 response), 37%-50% achieved 50% improvement (ACR 50 response), and up to 52% of patients achieved minimal disease activity at various time points. Also, radiographic progression was improved with anti-TNF therapy vs. placebo. However, TNF inhibitors lose efficacy over time in some patients, and are associated with an increased risk of infection.

Other disappointments or unmet needs in psoriatic arthritis are dichotomous skin and joint responses to biologics, lack of established predictors of response to biologics, lack of a cure, and difficulties in achieving sustained remission, Dr. McInnes said.

Future therapeutic options, including several drugs in development, include drugs that target cytokines and their receptors, such as ustekinumab, which targets IL-12/23; secukinumab and ixekizumab, which target IL-17; and brodalumab, which targets IL-17 receptor A. Other potential targets include IL-6 and the IL-6 receptor and IL-23 and the IL-23 receptor.

Studies of ustekinumab, for example, demonstrate beneficial effects on enthesitis, dactylitis, and modified van der Heijde-Sharp score.

Drugs that target intracellular signaling pathways are also being studied in psoriatic arthritis, including JAK family agents such as tofacitinib and phosphodiesterase inhibitors like apremilast.

As for strategies to improve outcomes, the Tight Control in Psoriatic Arthritis (TICOPA) study provided a rationale for treating to target. Current recommendations call for a target of remission or low disease activity.

The availability of highly effective biologics makes minimal level of disease activity a realistic treatment target, Dr. McInnes said.

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

Dr. McInnes reported receiving research/grant support from Pfizer, Bristol-Myers Squibb, AstraZeneca, and Novo Nordisk, and serving as a consultant to Novartis, Bristol-Myers Squibb, Pfizer, and Galapagos. He is a member of scientific advisory boards for AstraZeneca, Crescendo Bioscience, and Janssen Biotech.

LAS VEGAS – A number of drugs are showing promise for the treatment of psoriatic arthritis, but broader improvements are needed with respect to treatment strategies, according to Dr. Iain McInnes.

Earlier diagnosis, appropriate therapies, and treating to target are among the topics he covered in a presentation on maximizing patient outcomes at the annual Perspectives in Rheumatic Diseases.

A recent study demonstrated that even a 6-month delay in the diagnosis of psoriatic arthritis is associated with worse long-term outcomes on several measures. In that study of 283 patients (Ann. Rheum. Dis. 2014 Feb. 13 [doi: 10.1136/annrheumdis-2013-204858]), the median lag time from disease onset to first rheumatological assessment was 1 year, with only 30% of patients being seen by a rheumatologist within 6 months.

Multiple stepwise regression analysis showed that late consulters had a greater risk of developing peripheral joint erosions (odds ratio, 4.25) and had worse Health Assessment Questionnaire scores (odds ratio, 2.2).

One finding that could help with earlier diagnosis is detection of early entheseal involvement, said Dr. McInnes, professor of medicine and director of the Institute of Infection, Immunity and Immunology at the University of Glasgow (Scotland).

Subclinical entheseal involvement appears to predict psoriatic arthritis in patients presenting with psoriasis, he said at the conference.

In one study, the mean Glasgow Ultrasound Enthesitis Scoring System (GUESS) score was 7.9 in patients with psoriasis, compared with 2.9 in controls, and in another study, thickness of the quadriceps tendon was a significant predictor of the development of psoriatic arthritis in those with psoriasis.

A key challenge in maximizing outcomes in psoriatic arthritis is that rheumatoid arthritis and psoriatic arthritis are typically treated as homogeneous for the purposes of drug development, but the two diseases have distinct clinical phenotypes and time course, tissue distribution, tissue cell/molecular features, genetic susceptibility, and probably impact of immune senescence.

In fact, while disease-modifying antirheumatic drugs are included in European League Against Rheumatsm (EULAR) treatment guidelines for psoriatic arthritis, the Methotrexate in Psoriatic Arthritis (MIPA) trial, a 6-month, double-blind, randomized, placebo-controlled trial of methotrexate, showed no benefit for key psoriatic arthritis endpoints at 3 and 6 months (Rheumatology 2012;51:1368-77).

Data on methotrexate combination therapy is limited, but existing clinical trials and registry data show no clear evidence of benefit. Methotrexate also has long-term toxicity issues.

In studies of patients who received anti–tumor necrosis factor therapy, 59%-69% of patients achieved 20% improvement (ACR 20 response), 37%-50% achieved 50% improvement (ACR 50 response), and up to 52% of patients achieved minimal disease activity at various time points. Also, radiographic progression was improved with anti-TNF therapy vs. placebo. However, TNF inhibitors lose efficacy over time in some patients, and are associated with an increased risk of infection.

Other disappointments or unmet needs in psoriatic arthritis are dichotomous skin and joint responses to biologics, lack of established predictors of response to biologics, lack of a cure, and difficulties in achieving sustained remission, Dr. McInnes said.

Future therapeutic options, including several drugs in development, include drugs that target cytokines and their receptors, such as ustekinumab, which targets IL-12/23; secukinumab and ixekizumab, which target IL-17; and brodalumab, which targets IL-17 receptor A. Other potential targets include IL-6 and the IL-6 receptor and IL-23 and the IL-23 receptor.

Studies of ustekinumab, for example, demonstrate beneficial effects on enthesitis, dactylitis, and modified van der Heijde-Sharp score.

Drugs that target intracellular signaling pathways are also being studied in psoriatic arthritis, including JAK family agents such as tofacitinib and phosphodiesterase inhibitors like apremilast.

As for strategies to improve outcomes, the Tight Control in Psoriatic Arthritis (TICOPA) study provided a rationale for treating to target. Current recommendations call for a target of remission or low disease activity.

The availability of highly effective biologics makes minimal level of disease activity a realistic treatment target, Dr. McInnes said.

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

Dr. McInnes reported receiving research/grant support from Pfizer, Bristol-Myers Squibb, AstraZeneca, and Novo Nordisk, and serving as a consultant to Novartis, Bristol-Myers Squibb, Pfizer, and Galapagos. He is a member of scientific advisory boards for AstraZeneca, Crescendo Bioscience, and Janssen Biotech.

LAS VEGAS – A number of drugs are showing promise for the treatment of psoriatic arthritis, but broader improvements are needed with respect to treatment strategies, according to Dr. Iain McInnes.

Earlier diagnosis, appropriate therapies, and treating to target are among the topics he covered in a presentation on maximizing patient outcomes at the annual Perspectives in Rheumatic Diseases.

A recent study demonstrated that even a 6-month delay in the diagnosis of psoriatic arthritis is associated with worse long-term outcomes on several measures. In that study of 283 patients (Ann. Rheum. Dis. 2014 Feb. 13 [doi: 10.1136/annrheumdis-2013-204858]), the median lag time from disease onset to first rheumatological assessment was 1 year, with only 30% of patients being seen by a rheumatologist within 6 months.

Multiple stepwise regression analysis showed that late consulters had a greater risk of developing peripheral joint erosions (odds ratio, 4.25) and had worse Health Assessment Questionnaire scores (odds ratio, 2.2).

One finding that could help with earlier diagnosis is detection of early entheseal involvement, said Dr. McInnes, professor of medicine and director of the Institute of Infection, Immunity and Immunology at the University of Glasgow (Scotland).

Subclinical entheseal involvement appears to predict psoriatic arthritis in patients presenting with psoriasis, he said at the conference.

In one study, the mean Glasgow Ultrasound Enthesitis Scoring System (GUESS) score was 7.9 in patients with psoriasis, compared with 2.9 in controls, and in another study, thickness of the quadriceps tendon was a significant predictor of the development of psoriatic arthritis in those with psoriasis.

A key challenge in maximizing outcomes in psoriatic arthritis is that rheumatoid arthritis and psoriatic arthritis are typically treated as homogeneous for the purposes of drug development, but the two diseases have distinct clinical phenotypes and time course, tissue distribution, tissue cell/molecular features, genetic susceptibility, and probably impact of immune senescence.

In fact, while disease-modifying antirheumatic drugs are included in European League Against Rheumatsm (EULAR) treatment guidelines for psoriatic arthritis, the Methotrexate in Psoriatic Arthritis (MIPA) trial, a 6-month, double-blind, randomized, placebo-controlled trial of methotrexate, showed no benefit for key psoriatic arthritis endpoints at 3 and 6 months (Rheumatology 2012;51:1368-77).

Data on methotrexate combination therapy is limited, but existing clinical trials and registry data show no clear evidence of benefit. Methotrexate also has long-term toxicity issues.

In studies of patients who received anti–tumor necrosis factor therapy, 59%-69% of patients achieved 20% improvement (ACR 20 response), 37%-50% achieved 50% improvement (ACR 50 response), and up to 52% of patients achieved minimal disease activity at various time points. Also, radiographic progression was improved with anti-TNF therapy vs. placebo. However, TNF inhibitors lose efficacy over time in some patients, and are associated with an increased risk of infection.

Other disappointments or unmet needs in psoriatic arthritis are dichotomous skin and joint responses to biologics, lack of established predictors of response to biologics, lack of a cure, and difficulties in achieving sustained remission, Dr. McInnes said.

Future therapeutic options, including several drugs in development, include drugs that target cytokines and their receptors, such as ustekinumab, which targets IL-12/23; secukinumab and ixekizumab, which target IL-17; and brodalumab, which targets IL-17 receptor A. Other potential targets include IL-6 and the IL-6 receptor and IL-23 and the IL-23 receptor.

Studies of ustekinumab, for example, demonstrate beneficial effects on enthesitis, dactylitis, and modified van der Heijde-Sharp score.

Drugs that target intracellular signaling pathways are also being studied in psoriatic arthritis, including JAK family agents such as tofacitinib and phosphodiesterase inhibitors like apremilast.

As for strategies to improve outcomes, the Tight Control in Psoriatic Arthritis (TICOPA) study provided a rationale for treating to target. Current recommendations call for a target of remission or low disease activity.

The availability of highly effective biologics makes minimal level of disease activity a realistic treatment target, Dr. McInnes said.

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

Dr. McInnes reported receiving research/grant support from Pfizer, Bristol-Myers Squibb, AstraZeneca, and Novo Nordisk, and serving as a consultant to Novartis, Bristol-Myers Squibb, Pfizer, and Galapagos. He is a member of scientific advisory boards for AstraZeneca, Crescendo Bioscience, and Janssen Biotech.