A patient treated with immune checkpoint inhibitor therapy for thyroid carcinoma presented with lichenoid dermatitis that resembled mycosis fungoides and also showed with monoclonal T-cell receptor gene rearrangement.

A case report published in the Journal of Cutaneous Pathology describes the “unusual” case and highlights another form of lichenoid dermatitis that may occur with immune checkpoint inhibitor therapy.

The patient was a 66-year-old man with BRAF_V600E-mutated anaplastic thyroid carcinoma, who was enrolled in a clinical trial of the checkpoint inhibitor atezolizumab, in combination with the BRAF inhibitor vemurafenib and MEK inhibitor cobimetinib.

Around 11 months after starting treatment, he presented to a dermatology department with a 1.5-cm x 1.2-cm crusted, erythematous plaque on his abdomen that had appeared 3 weeks earlier. He also had several follicular-based erythematous papules on his extremities and a single verrucous papule on his index finger, which the authors wrote were likely associated with the vemurafenib therapy.

The patient had previously had a squamous cell carcinoma removed but had no history of cutaneous lymphoma.

A punch biopsy of the abdominal lesion showed dense lichenoid, lymphohistiocytic infiltrate with papillary dermal fibrosis, and scattered multinucleated giant histiocytes. Immunohistochemical studies showed the lesion had an abnormal immunophenotype in which CD4+ cells were four to five times more common than CD8+ cells, and there was partial loss of CD7 expression.

The lesion was treated with 0.05% clobetasol cream and monitored without interrupting the cancer therapy. The lesion gradually reduced in size, but 4 months later, another lesion appeared on the patient’s right clavicle.

A skin biopsy revealed lichenoid lymphohistiocytic infiltrate with occasional giant cells in the superficial dermis, as well as atypical, hyperchromatic lymphocytes with clear halos. Immunohistochemical studies showed that the new lesion was similar to the earlier abdominal lesion.

T-cell receptor gene rearrangement studies on both lesions showed that the abdominal lesion had both monoclonal TCR-gamma and TCR-beta gene rearrangements. The clavicle lesion showed the same monoclonal TCR-gamma rearrangement as the abdominal lesion, but lacked the TCR-beta gene rearrangement.

The lesions continued to be treated with clobetasol cream (0.05%), and the patient remained on the anticancer treatment regimen.

Michael T. Tetzlaff, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and coauthors wrote that up to half of all patients treated with immune checkpoint inhibitors develop some kind of cutaneous immune-related adverse event, and lichenoid dermatitis is one of the most common seen in biopsies.

“Clinical and pathological recognition of monoclonal [lichenoid dermatitis associated with immune checkpoint inhibitors] in the context of [immune checkpoint inhibitor] therapy will be important for accurate diagnosis and patient care,” they wrote.

The researchers did not report financial disclosures.

SOURCE: Tetzlaff MT et al. J Cutan Pathol. 2019 Jun 29. doi: 10.1111/cup.13536.

A patient treated with immune checkpoint inhibitor therapy for thyroid carcinoma presented with lichenoid dermatitis that resembled mycosis fungoides and also showed with monoclonal T-cell receptor gene rearrangement.

A case report published in the Journal of Cutaneous Pathology describes the “unusual” case and highlights another form of lichenoid dermatitis that may occur with immune checkpoint inhibitor therapy.

The patient was a 66-year-old man with BRAF_V600E-mutated anaplastic thyroid carcinoma, who was enrolled in a clinical trial of the checkpoint inhibitor atezolizumab, in combination with the BRAF inhibitor vemurafenib and MEK inhibitor cobimetinib.

Around 11 months after starting treatment, he presented to a dermatology department with a 1.5-cm x 1.2-cm crusted, erythematous plaque on his abdomen that had appeared 3 weeks earlier. He also had several follicular-based erythematous papules on his extremities and a single verrucous papule on his index finger, which the authors wrote were likely associated with the vemurafenib therapy.

The patient had previously had a squamous cell carcinoma removed but had no history of cutaneous lymphoma.

A punch biopsy of the abdominal lesion showed dense lichenoid, lymphohistiocytic infiltrate with papillary dermal fibrosis, and scattered multinucleated giant histiocytes. Immunohistochemical studies showed the lesion had an abnormal immunophenotype in which CD4+ cells were four to five times more common than CD8+ cells, and there was partial loss of CD7 expression.

The lesion was treated with 0.05% clobetasol cream and monitored without interrupting the cancer therapy. The lesion gradually reduced in size, but 4 months later, another lesion appeared on the patient’s right clavicle.

A skin biopsy revealed lichenoid lymphohistiocytic infiltrate with occasional giant cells in the superficial dermis, as well as atypical, hyperchromatic lymphocytes with clear halos. Immunohistochemical studies showed that the new lesion was similar to the earlier abdominal lesion.

T-cell receptor gene rearrangement studies on both lesions showed that the abdominal lesion had both monoclonal TCR-gamma and TCR-beta gene rearrangements. The clavicle lesion showed the same monoclonal TCR-gamma rearrangement as the abdominal lesion, but lacked the TCR-beta gene rearrangement.

The lesions continued to be treated with clobetasol cream (0.05%), and the patient remained on the anticancer treatment regimen.

Michael T. Tetzlaff, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and coauthors wrote that up to half of all patients treated with immune checkpoint inhibitors develop some kind of cutaneous immune-related adverse event, and lichenoid dermatitis is one of the most common seen in biopsies.

“Clinical and pathological recognition of monoclonal [lichenoid dermatitis associated with immune checkpoint inhibitors] in the context of [immune checkpoint inhibitor] therapy will be important for accurate diagnosis and patient care,” they wrote.

The researchers did not report financial disclosures.

SOURCE: Tetzlaff MT et al. J Cutan Pathol. 2019 Jun 29. doi: 10.1111/cup.13536.

A patient treated with immune checkpoint inhibitor therapy for thyroid carcinoma presented with lichenoid dermatitis that resembled mycosis fungoides and also showed with monoclonal T-cell receptor gene rearrangement.

A case report published in the Journal of Cutaneous Pathology describes the “unusual” case and highlights another form of lichenoid dermatitis that may occur with immune checkpoint inhibitor therapy.

The patient was a 66-year-old man with BRAF_V600E-mutated anaplastic thyroid carcinoma, who was enrolled in a clinical trial of the checkpoint inhibitor atezolizumab, in combination with the BRAF inhibitor vemurafenib and MEK inhibitor cobimetinib.

Around 11 months after starting treatment, he presented to a dermatology department with a 1.5-cm x 1.2-cm crusted, erythematous plaque on his abdomen that had appeared 3 weeks earlier. He also had several follicular-based erythematous papules on his extremities and a single verrucous papule on his index finger, which the authors wrote were likely associated with the vemurafenib therapy.

The patient had previously had a squamous cell carcinoma removed but had no history of cutaneous lymphoma.

A punch biopsy of the abdominal lesion showed dense lichenoid, lymphohistiocytic infiltrate with papillary dermal fibrosis, and scattered multinucleated giant histiocytes. Immunohistochemical studies showed the lesion had an abnormal immunophenotype in which CD4+ cells were four to five times more common than CD8+ cells, and there was partial loss of CD7 expression.

The lesion was treated with 0.05% clobetasol cream and monitored without interrupting the cancer therapy. The lesion gradually reduced in size, but 4 months later, another lesion appeared on the patient’s right clavicle.

A skin biopsy revealed lichenoid lymphohistiocytic infiltrate with occasional giant cells in the superficial dermis, as well as atypical, hyperchromatic lymphocytes with clear halos. Immunohistochemical studies showed that the new lesion was similar to the earlier abdominal lesion.

T-cell receptor gene rearrangement studies on both lesions showed that the abdominal lesion had both monoclonal TCR-gamma and TCR-beta gene rearrangements. The clavicle lesion showed the same monoclonal TCR-gamma rearrangement as the abdominal lesion, but lacked the TCR-beta gene rearrangement.

The lesions continued to be treated with clobetasol cream (0.05%), and the patient remained on the anticancer treatment regimen.

Michael T. Tetzlaff, MD, PhD, of the University of Texas MD Anderson Cancer Center, Houston, and coauthors wrote that up to half of all patients treated with immune checkpoint inhibitors develop some kind of cutaneous immune-related adverse event, and lichenoid dermatitis is one of the most common seen in biopsies.

“Clinical and pathological recognition of monoclonal [lichenoid dermatitis associated with immune checkpoint inhibitors] in the context of [immune checkpoint inhibitor] therapy will be important for accurate diagnosis and patient care,” they wrote.

The researchers did not report financial disclosures.

SOURCE: Tetzlaff MT et al. J Cutan Pathol. 2019 Jun 29. doi: 10.1111/cup.13536.

If you are a medical student, a general surgery resident and/or a trainee who’d like to get more involved within the Society for Vascular Surgery, apply to be an SVS Social Media Ambassador. Ambassadors must be members of the SVS and understand the basic concept of social media. Once a part of the program, they are encouraged to be advocates for the SVS and provide honest feedback to the staff as to what they’d like to see on our channels. If you are interested, learn more about the program here and apply today.

If you are a medical student, a general surgery resident and/or a trainee who’d like to get more involved within the Society for Vascular Surgery, apply to be an SVS Social Media Ambassador. Ambassadors must be members of the SVS and understand the basic concept of social media. Once a part of the program, they are encouraged to be advocates for the SVS and provide honest feedback to the staff as to what they’d like to see on our channels. If you are interested, learn more about the program here and apply today.

If you are a medical student, a general surgery resident and/or a trainee who’d like to get more involved within the Society for Vascular Surgery, apply to be an SVS Social Media Ambassador. Ambassadors must be members of the SVS and understand the basic concept of social media. Once a part of the program, they are encouraged to be advocates for the SVS and provide honest feedback to the staff as to what they’d like to see on our channels. If you are interested, learn more about the program here and apply today.

The Society for Vascular Surgery is establishing a new Health Information Technology Task Force. The SVS Executive Board is seeking members with a desire to explore and advance technology-based health improvement for vascular patients. Volunteers should be interested in, as well as have some experience with, technology-related health improvements, medical informatics, etc. Selected task force members will collaborate with non-member industry technology experts, as well as SVS leadership. If you’d like to be considered, please email a brief statement of interest to ehall@vascularsociety.org. Read all the details here.

The Society for Vascular Surgery is establishing a new Health Information Technology Task Force. The SVS Executive Board is seeking members with a desire to explore and advance technology-based health improvement for vascular patients. Volunteers should be interested in, as well as have some experience with, technology-related health improvements, medical informatics, etc. Selected task force members will collaborate with non-member industry technology experts, as well as SVS leadership. If you’d like to be considered, please email a brief statement of interest to ehall@vascularsociety.org. Read all the details here.

The Society for Vascular Surgery is establishing a new Health Information Technology Task Force. The SVS Executive Board is seeking members with a desire to explore and advance technology-based health improvement for vascular patients. Volunteers should be interested in, as well as have some experience with, technology-related health improvements, medical informatics, etc. Selected task force members will collaborate with non-member industry technology experts, as well as SVS leadership. If you’d like to be considered, please email a brief statement of interest to ehall@vascularsociety.org. Read all the details here.

NEW YORK – Is there an association between sunscreen use and frontal fibrosing alopecia? Perhaps, but causation is far from well established, according to Henry Lim, MD.

“Frontal fibrosing alopecia is becoming more common – definitely,” said Dr. Lim, speaking in an exclusive interview at the American Academy of Dermatology summer meeting. “Those of us who see patients would see, on average, probably a few patients a week with new-onset frontal fibrosing alopecia.”

Dr. Lim, program director of dermatology research and the photomedicine fellowship at Henry Ford Hospital, Detroit, said in a presentation at the meeting that, in the medical literature, just four surveys have been identified that examined the potential association of UV filters in sunscreen preparations with the risk for frontal fibrosing alopecia (FFA).

The first survey-based study questioned 205 women – 105 of whom had FFA – about sunscreen use, finding increased risk for FFA when sunscreen use was reported at least twice a week (Br J Dermatol. 2016 Oct;175:762-7). The second study, by contrast, looked at men only, examining 17 patients with FFA and 73 control participants. This study found increased frequency of FFA in patients who reported use of sunscreen or sunscreen-containing moisturizers (Br J Dermatol. 2011 Jul;177:260-1).

The final two survey-based studies each also found increased FFA frequency in patients using sunscreens, said Dr. Lim. The first of these was the largest among the FFA studies, surveying 308 patients, 19 of whom were men, with FFA and 347 control participants (Clin Exp Dermatol. 2019 Jun;44:404-10). The other study, involving women only, compared 130 patients with FFA and 130 control participants (Br J Dermatol. 2019 Apr;180:943-4).

Several factors need to be taken into consideration when evaluating the available data, said Dr. Lim. “With any type of retrospective study, there are some limitations, recall bias being one. No. 2, the studies were not designed to look at which sunscreens’ ingredient is causing the frontal fibrosing alopecia, so all we can say is that there is an association of sunscreen with frontal fibrosing alopecia without knowing which active ingredient is involved.”

Also, “there is no conclusion that we can draw in terms of causation,” he said. Data are insufficient for this kind of inference.

Titanium dioxide, a mineral filter used in some sunscreen preparations, has also been implicated in FFA. Elemental titanium has been detected in the hair shafts of some patients with alopecia, said Dr. Lim, noting a case report and another small study. In the smaller study, 20 patients were included. Of them, 16 were FFA-affected women, 4 were unaffected women, and 1 was an unaffected man. Here, however, titanium was found in the hair shaft of all participants save the one unaffected man (Br J Dermatol. 2019 Jul;181:216-7).

However, he warned, “the studies are still early. The numbers are still relatively small that have been examined.” Furthermore, the controls, meaning individuals who did not have FFA in the study, also had titanium element in their hair shaft. All of this means that it’s too early to draw firm conclusions about whether there’s a causal relationship between titanium-containing preparations and FFA.

In questioning after the session, an audience member pointed out that sunscreens are not the sole source of titanium among topical preparations; many cosmetics and hair products also use titanium.

Dr. Lim reported financial relationships with Eli Lilly, Estee Lauder, Ferndale Laboratories, Incyte Corporation, ISDIN, Pierre Fabre Dermatologie, and Unigen.

koakes@mdedge.com

NEW YORK – Is there an association between sunscreen use and frontal fibrosing alopecia? Perhaps, but causation is far from well established, according to Henry Lim, MD.

“Frontal fibrosing alopecia is becoming more common – definitely,” said Dr. Lim, speaking in an exclusive interview at the American Academy of Dermatology summer meeting. “Those of us who see patients would see, on average, probably a few patients a week with new-onset frontal fibrosing alopecia.”

Dr. Lim, program director of dermatology research and the photomedicine fellowship at Henry Ford Hospital, Detroit, said in a presentation at the meeting that, in the medical literature, just four surveys have been identified that examined the potential association of UV filters in sunscreen preparations with the risk for frontal fibrosing alopecia (FFA).

The first survey-based study questioned 205 women – 105 of whom had FFA – about sunscreen use, finding increased risk for FFA when sunscreen use was reported at least twice a week (Br J Dermatol. 2016 Oct;175:762-7). The second study, by contrast, looked at men only, examining 17 patients with FFA and 73 control participants. This study found increased frequency of FFA in patients who reported use of sunscreen or sunscreen-containing moisturizers (Br J Dermatol. 2011 Jul;177:260-1).

The final two survey-based studies each also found increased FFA frequency in patients using sunscreens, said Dr. Lim. The first of these was the largest among the FFA studies, surveying 308 patients, 19 of whom were men, with FFA and 347 control participants (Clin Exp Dermatol. 2019 Jun;44:404-10). The other study, involving women only, compared 130 patients with FFA and 130 control participants (Br J Dermatol. 2019 Apr;180:943-4).

Several factors need to be taken into consideration when evaluating the available data, said Dr. Lim. “With any type of retrospective study, there are some limitations, recall bias being one. No. 2, the studies were not designed to look at which sunscreens’ ingredient is causing the frontal fibrosing alopecia, so all we can say is that there is an association of sunscreen with frontal fibrosing alopecia without knowing which active ingredient is involved.”

Also, “there is no conclusion that we can draw in terms of causation,” he said. Data are insufficient for this kind of inference.

Titanium dioxide, a mineral filter used in some sunscreen preparations, has also been implicated in FFA. Elemental titanium has been detected in the hair shafts of some patients with alopecia, said Dr. Lim, noting a case report and another small study. In the smaller study, 20 patients were included. Of them, 16 were FFA-affected women, 4 were unaffected women, and 1 was an unaffected man. Here, however, titanium was found in the hair shaft of all participants save the one unaffected man (Br J Dermatol. 2019 Jul;181:216-7).

However, he warned, “the studies are still early. The numbers are still relatively small that have been examined.” Furthermore, the controls, meaning individuals who did not have FFA in the study, also had titanium element in their hair shaft. All of this means that it’s too early to draw firm conclusions about whether there’s a causal relationship between titanium-containing preparations and FFA.

In questioning after the session, an audience member pointed out that sunscreens are not the sole source of titanium among topical preparations; many cosmetics and hair products also use titanium.

Dr. Lim reported financial relationships with Eli Lilly, Estee Lauder, Ferndale Laboratories, Incyte Corporation, ISDIN, Pierre Fabre Dermatologie, and Unigen.

koakes@mdedge.com

NEW YORK – Is there an association between sunscreen use and frontal fibrosing alopecia? Perhaps, but causation is far from well established, according to Henry Lim, MD.

“Frontal fibrosing alopecia is becoming more common – definitely,” said Dr. Lim, speaking in an exclusive interview at the American Academy of Dermatology summer meeting. “Those of us who see patients would see, on average, probably a few patients a week with new-onset frontal fibrosing alopecia.”

Dr. Lim, program director of dermatology research and the photomedicine fellowship at Henry Ford Hospital, Detroit, said in a presentation at the meeting that, in the medical literature, just four surveys have been identified that examined the potential association of UV filters in sunscreen preparations with the risk for frontal fibrosing alopecia (FFA).

The first survey-based study questioned 205 women – 105 of whom had FFA – about sunscreen use, finding increased risk for FFA when sunscreen use was reported at least twice a week (Br J Dermatol. 2016 Oct;175:762-7). The second study, by contrast, looked at men only, examining 17 patients with FFA and 73 control participants. This study found increased frequency of FFA in patients who reported use of sunscreen or sunscreen-containing moisturizers (Br J Dermatol. 2011 Jul;177:260-1).

The final two survey-based studies each also found increased FFA frequency in patients using sunscreens, said Dr. Lim. The first of these was the largest among the FFA studies, surveying 308 patients, 19 of whom were men, with FFA and 347 control participants (Clin Exp Dermatol. 2019 Jun;44:404-10). The other study, involving women only, compared 130 patients with FFA and 130 control participants (Br J Dermatol. 2019 Apr;180:943-4).

Several factors need to be taken into consideration when evaluating the available data, said Dr. Lim. “With any type of retrospective study, there are some limitations, recall bias being one. No. 2, the studies were not designed to look at which sunscreens’ ingredient is causing the frontal fibrosing alopecia, so all we can say is that there is an association of sunscreen with frontal fibrosing alopecia without knowing which active ingredient is involved.”

Also, “there is no conclusion that we can draw in terms of causation,” he said. Data are insufficient for this kind of inference.

Titanium dioxide, a mineral filter used in some sunscreen preparations, has also been implicated in FFA. Elemental titanium has been detected in the hair shafts of some patients with alopecia, said Dr. Lim, noting a case report and another small study. In the smaller study, 20 patients were included. Of them, 16 were FFA-affected women, 4 were unaffected women, and 1 was an unaffected man. Here, however, titanium was found in the hair shaft of all participants save the one unaffected man (Br J Dermatol. 2019 Jul;181:216-7).

However, he warned, “the studies are still early. The numbers are still relatively small that have been examined.” Furthermore, the controls, meaning individuals who did not have FFA in the study, also had titanium element in their hair shaft. All of this means that it’s too early to draw firm conclusions about whether there’s a causal relationship between titanium-containing preparations and FFA.

In questioning after the session, an audience member pointed out that sunscreens are not the sole source of titanium among topical preparations; many cosmetics and hair products also use titanium.

Dr. Lim reported financial relationships with Eli Lilly, Estee Lauder, Ferndale Laboratories, Incyte Corporation, ISDIN, Pierre Fabre Dermatologie, and Unigen.

koakes@mdedge.com

WASHINGTON – Personal advocacy can be more effective than even a legislative champion when approaching policy changes at the state level.

Gregory Twachtman/MDedge News

That was the message Matthew Lesser (D), deputy majority leader of the Connecticut state senate, told attendees at the National Comprehensive Cancer Network policy summit examining the impact of state policy on access to cancer care.

Mr. Lesser framed the advice around his own battle with cancer, a diagnosis that came with a need for immediate surgery within 36 hours. His diagnosis came with a recommendation for fertility preservation before he started treatment. And while the action for men is relatively inexpensive, he found after the fact that it could cost upwards of $15,000 for female cancer patients to undergo fertility preservation, and it was something insurance usually did not cover.

He made it a personal legislative priority to get a law on the books preventing insurance companies from restricting fertility coverage for those undergoing cancer treatment.

Mr. Lesser said he tried four times to get the bill passed but it failed to gain any traction. Then, in 2017, as he decided it would be his last attempt at getting a law passed, an advocate stepped up.

“This time something different happened,” he said. “We did the usual thing. We had a public hearing. Anybody can come up and speak. We don’t know in advance who that’s going to be.” A 32-year-old single mother battling advanced breast cancer, Melissa Thompson, “showed up at our public hearing and told her story.”

And it was her testimony, and persistent advocacy that followed, that won over the state legislators.

“Her story was incredibly powerful,” he recalled. “But for some of my more hard-nosed colleagues, stories aren’t enough. They want to see dollars and cents. They want to know the facts and the figures, and Melissa, a former Goldman Sachs analyst with an MBA from Columbia School of Business, was able to lay out dollars and cents argument much better than a lot of health professionals have been able to do.”

Her testimony was so powerful that Mr. Lesser said it was the only time he had seen a committee give an ovation to a witness.

Ms. Thompson followed up her appearance before a state committee with outreach to leadership on both sides of the aisle.

“Melissa changed the way we talked about the issue, and partly because this one person, this one Connecticut resident, reached out to every single member of the State senate,” he said. “She recorded a little video that she played to the 36 members of the state senate. She went and talked to Republican and Democratic leaders. She told her story. And she wouldn’t give up.”

And her work paid off, as H.B. 7124 passed with no dissenting votes in both chambers of the Connecticut state legislature, and was signed into law in 2017.

“This wasn’t something I did,” Mr. Lesser said. “It’s not something I could have done. I tried to do it and failed. But it does show the incredible power of individual advocates on the state level.”

The reason he thinks individual advocacy has a lot more impact on the state level is one of size and resources.

“Because state [governments] are so small, the power of individual advocates is enormous,” he stated. “Because we are so understaffed and so underresourced, compared to our colleagues on the federal level, that personal connection is magnified in importance.”

Mr. Lesser recalled other examples of how personal advocacy in Connecticut that have moved legislation in a bipartisan fashion in ways that would likely have otherwise failed without a voice outside the legislative body telling a personal story, including breast cancer imaging screening for women with dense breasts and raising the age for tobacco purchasing to 21.

gtwachtman@mdedge.com

WASHINGTON – Personal advocacy can be more effective than even a legislative champion when approaching policy changes at the state level.

Gregory Twachtman/MDedge News

That was the message Matthew Lesser (D), deputy majority leader of the Connecticut state senate, told attendees at the National Comprehensive Cancer Network policy summit examining the impact of state policy on access to cancer care.

Mr. Lesser framed the advice around his own battle with cancer, a diagnosis that came with a need for immediate surgery within 36 hours. His diagnosis came with a recommendation for fertility preservation before he started treatment. And while the action for men is relatively inexpensive, he found after the fact that it could cost upwards of $15,000 for female cancer patients to undergo fertility preservation, and it was something insurance usually did not cover.

He made it a personal legislative priority to get a law on the books preventing insurance companies from restricting fertility coverage for those undergoing cancer treatment.

Mr. Lesser said he tried four times to get the bill passed but it failed to gain any traction. Then, in 2017, as he decided it would be his last attempt at getting a law passed, an advocate stepped up.

“This time something different happened,” he said. “We did the usual thing. We had a public hearing. Anybody can come up and speak. We don’t know in advance who that’s going to be.” A 32-year-old single mother battling advanced breast cancer, Melissa Thompson, “showed up at our public hearing and told her story.”

And it was her testimony, and persistent advocacy that followed, that won over the state legislators.

“Her story was incredibly powerful,” he recalled. “But for some of my more hard-nosed colleagues, stories aren’t enough. They want to see dollars and cents. They want to know the facts and the figures, and Melissa, a former Goldman Sachs analyst with an MBA from Columbia School of Business, was able to lay out dollars and cents argument much better than a lot of health professionals have been able to do.”

Her testimony was so powerful that Mr. Lesser said it was the only time he had seen a committee give an ovation to a witness.

Ms. Thompson followed up her appearance before a state committee with outreach to leadership on both sides of the aisle.

“Melissa changed the way we talked about the issue, and partly because this one person, this one Connecticut resident, reached out to every single member of the State senate,” he said. “She recorded a little video that she played to the 36 members of the state senate. She went and talked to Republican and Democratic leaders. She told her story. And she wouldn’t give up.”

And her work paid off, as H.B. 7124 passed with no dissenting votes in both chambers of the Connecticut state legislature, and was signed into law in 2017.

“This wasn’t something I did,” Mr. Lesser said. “It’s not something I could have done. I tried to do it and failed. But it does show the incredible power of individual advocates on the state level.”

The reason he thinks individual advocacy has a lot more impact on the state level is one of size and resources.

“Because state [governments] are so small, the power of individual advocates is enormous,” he stated. “Because we are so understaffed and so underresourced, compared to our colleagues on the federal level, that personal connection is magnified in importance.”

Mr. Lesser recalled other examples of how personal advocacy in Connecticut that have moved legislation in a bipartisan fashion in ways that would likely have otherwise failed without a voice outside the legislative body telling a personal story, including breast cancer imaging screening for women with dense breasts and raising the age for tobacco purchasing to 21.

gtwachtman@mdedge.com

WASHINGTON – Personal advocacy can be more effective than even a legislative champion when approaching policy changes at the state level.

Gregory Twachtman/MDedge News

That was the message Matthew Lesser (D), deputy majority leader of the Connecticut state senate, told attendees at the National Comprehensive Cancer Network policy summit examining the impact of state policy on access to cancer care.

Mr. Lesser framed the advice around his own battle with cancer, a diagnosis that came with a need for immediate surgery within 36 hours. His diagnosis came with a recommendation for fertility preservation before he started treatment. And while the action for men is relatively inexpensive, he found after the fact that it could cost upwards of $15,000 for female cancer patients to undergo fertility preservation, and it was something insurance usually did not cover.

He made it a personal legislative priority to get a law on the books preventing insurance companies from restricting fertility coverage for those undergoing cancer treatment.

Mr. Lesser said he tried four times to get the bill passed but it failed to gain any traction. Then, in 2017, as he decided it would be his last attempt at getting a law passed, an advocate stepped up.

“This time something different happened,” he said. “We did the usual thing. We had a public hearing. Anybody can come up and speak. We don’t know in advance who that’s going to be.” A 32-year-old single mother battling advanced breast cancer, Melissa Thompson, “showed up at our public hearing and told her story.”

And it was her testimony, and persistent advocacy that followed, that won over the state legislators.

“Her story was incredibly powerful,” he recalled. “But for some of my more hard-nosed colleagues, stories aren’t enough. They want to see dollars and cents. They want to know the facts and the figures, and Melissa, a former Goldman Sachs analyst with an MBA from Columbia School of Business, was able to lay out dollars and cents argument much better than a lot of health professionals have been able to do.”

Her testimony was so powerful that Mr. Lesser said it was the only time he had seen a committee give an ovation to a witness.

Ms. Thompson followed up her appearance before a state committee with outreach to leadership on both sides of the aisle.

“Melissa changed the way we talked about the issue, and partly because this one person, this one Connecticut resident, reached out to every single member of the State senate,” he said. “She recorded a little video that she played to the 36 members of the state senate. She went and talked to Republican and Democratic leaders. She told her story. And she wouldn’t give up.”

And her work paid off, as H.B. 7124 passed with no dissenting votes in both chambers of the Connecticut state legislature, and was signed into law in 2017.

“This wasn’t something I did,” Mr. Lesser said. “It’s not something I could have done. I tried to do it and failed. But it does show the incredible power of individual advocates on the state level.”

The reason he thinks individual advocacy has a lot more impact on the state level is one of size and resources.

“Because state [governments] are so small, the power of individual advocates is enormous,” he stated. “Because we are so understaffed and so underresourced, compared to our colleagues on the federal level, that personal connection is magnified in importance.”

Mr. Lesser recalled other examples of how personal advocacy in Connecticut that have moved legislation in a bipartisan fashion in ways that would likely have otherwise failed without a voice outside the legislative body telling a personal story, including breast cancer imaging screening for women with dense breasts and raising the age for tobacco purchasing to 21.

gtwachtman@mdedge.com

For patients, including patients who are physicians, knowledge isn’t power, according to investigators.

megaflopp/Thinkstock

A literature review and retrospective analysis of more than 35,000 physicians treated as patients revealed minimal associations between level of medical knowledge and quality of health outcomes, reported Michael D. Frakes, PhD, of Duke University, Durham, N.C., and colleagues. The study findings stand in opposition to the “widely prevailing view” that information and medical knowledge among patients are integral to realizing high-quality, low-cost health care, the investigators noted.

“[This] research is particularly relevant to modern discussions and debates about the consumer-driven health care movement and the use of plans with high deductibles and high copayments to encourage greater patient and consumer involvement in health care decision making,” Dr. Frakes said in an interview. “Recent research has suggested that the financial incentives created by such structures discourage the use of both low-value care and high-value care. Some have argued that greater disclosure of information to patients may address this concern and steer patients towards high-value decisions. Our results cast doubt on the potential for information initiatives alone to meet this aim.”

The study is one of the first of its kind, the investigators noted in the National Bureau of Economic Research working paper. Other than a 2016 publication that found that physician mothers were less likely to have cesarean sections (Am Econ J: Econ Policy. 2016;8[1]:115-41), “there is no work which has been able to study the role of physicians as patients,” they wrote.

To fill this gap, the investigators turned to a unique data source: The Military Health System, which provides insurance to active and retired military personnel and their families. Military Health System spending exceeds $50 billion per year, constituting a major portion of American health care expenditures, and with more than 35,000 military physicians treated as patients, the dataset is highly relevant and powerful. The investigators objectively evaluated health outcomes by focusing on evidence-based, measurable clinical decisions deemed “high value” or “low value,” comparing how the frequency of these choices related with physician versus nonphysician patient status.

Coauthor Jonathan Gruber, PhD, of the Massachusetts Institute of Technology in Cambridge, Mass., explained this methodology in an interview. “The literature is clear that high-value care has positive health outcomes with relatively small increases in health care spending, and that low-value care has no impact on health outcomes with large increases in spending.”

“One concern with this analysis, of course, is that physicians may be of different health statuses and have different tastes for medical interventions than nonphysicians,” the investigators wrote. They addressed this problem in five ways, by focusing on widely accepted medical standards that apply to all patients; examining both high- and low-value care to eliminate one-sided bias; controlling for underlying health differences across groups; comparing physicians with other military officers to account for underlying tastes; and evaluating military officer dependents in comparison with physician dependents, the latter of whom may benefit from medical knowledge by virtue of personal relationship.

“Our results suggest that physicians do only slightly better than nonphysicians,” the investigators wrote, “but not by much and not always.” Low-value care was slightly less common among physicians, but this difference was described as “modest.” Analysis of high-value care was more mixed, with some results supporting equivalence between groups and others pointing to a slightly higher rate of high-value care among physician patients.

“These results provide a rough boundary on the extent to which additional information disclosure [beyond prevailing levels] can be expected to improve the delivery of health care in the U.S.,” the investigators wrote. “[M]ost of the explanation behind the over- and underutilization of low- and high-value services likely arises from factors other than informational deficiencies of patients.”

“Perhaps one interpretation of these findings is that patients remain generally deferential to the care recommendations of their treating physicians, even in the case of near fully informed patients,” the investigators wrote, noting that this interpretation aligns with a recent working paper that found that physicians play a greater role in selecting the site of MRI scans than patient cost-sharing factors.

Looking to the future, Dr. Gruber said that he and his colleagues plan on exploring “what drives this lack of response among physicians [as patients].”

The study was funded by the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Frakes MD et al. Natl Bur Econ Res. 2019 Jul. doi: 10.3386/w26038.

This article was updated 8/6/19.

For patients, including patients who are physicians, knowledge isn’t power, according to investigators.

megaflopp/Thinkstock

A literature review and retrospective analysis of more than 35,000 physicians treated as patients revealed minimal associations between level of medical knowledge and quality of health outcomes, reported Michael D. Frakes, PhD, of Duke University, Durham, N.C., and colleagues. The study findings stand in opposition to the “widely prevailing view” that information and medical knowledge among patients are integral to realizing high-quality, low-cost health care, the investigators noted.

“[This] research is particularly relevant to modern discussions and debates about the consumer-driven health care movement and the use of plans with high deductibles and high copayments to encourage greater patient and consumer involvement in health care decision making,” Dr. Frakes said in an interview. “Recent research has suggested that the financial incentives created by such structures discourage the use of both low-value care and high-value care. Some have argued that greater disclosure of information to patients may address this concern and steer patients towards high-value decisions. Our results cast doubt on the potential for information initiatives alone to meet this aim.”

The study is one of the first of its kind, the investigators noted in the National Bureau of Economic Research working paper. Other than a 2016 publication that found that physician mothers were less likely to have cesarean sections (Am Econ J: Econ Policy. 2016;8[1]:115-41), “there is no work which has been able to study the role of physicians as patients,” they wrote.

To fill this gap, the investigators turned to a unique data source: The Military Health System, which provides insurance to active and retired military personnel and their families. Military Health System spending exceeds $50 billion per year, constituting a major portion of American health care expenditures, and with more than 35,000 military physicians treated as patients, the dataset is highly relevant and powerful. The investigators objectively evaluated health outcomes by focusing on evidence-based, measurable clinical decisions deemed “high value” or “low value,” comparing how the frequency of these choices related with physician versus nonphysician patient status.

Coauthor Jonathan Gruber, PhD, of the Massachusetts Institute of Technology in Cambridge, Mass., explained this methodology in an interview. “The literature is clear that high-value care has positive health outcomes with relatively small increases in health care spending, and that low-value care has no impact on health outcomes with large increases in spending.”

“One concern with this analysis, of course, is that physicians may be of different health statuses and have different tastes for medical interventions than nonphysicians,” the investigators wrote. They addressed this problem in five ways, by focusing on widely accepted medical standards that apply to all patients; examining both high- and low-value care to eliminate one-sided bias; controlling for underlying health differences across groups; comparing physicians with other military officers to account for underlying tastes; and evaluating military officer dependents in comparison with physician dependents, the latter of whom may benefit from medical knowledge by virtue of personal relationship.

“Our results suggest that physicians do only slightly better than nonphysicians,” the investigators wrote, “but not by much and not always.” Low-value care was slightly less common among physicians, but this difference was described as “modest.” Analysis of high-value care was more mixed, with some results supporting equivalence between groups and others pointing to a slightly higher rate of high-value care among physician patients.

“These results provide a rough boundary on the extent to which additional information disclosure [beyond prevailing levels] can be expected to improve the delivery of health care in the U.S.,” the investigators wrote. “[M]ost of the explanation behind the over- and underutilization of low- and high-value services likely arises from factors other than informational deficiencies of patients.”

“Perhaps one interpretation of these findings is that patients remain generally deferential to the care recommendations of their treating physicians, even in the case of near fully informed patients,” the investigators wrote, noting that this interpretation aligns with a recent working paper that found that physicians play a greater role in selecting the site of MRI scans than patient cost-sharing factors.

Looking to the future, Dr. Gruber said that he and his colleagues plan on exploring “what drives this lack of response among physicians [as patients].”

The study was funded by the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Frakes MD et al. Natl Bur Econ Res. 2019 Jul. doi: 10.3386/w26038.

This article was updated 8/6/19.

For patients, including patients who are physicians, knowledge isn’t power, according to investigators.

megaflopp/Thinkstock

A literature review and retrospective analysis of more than 35,000 physicians treated as patients revealed minimal associations between level of medical knowledge and quality of health outcomes, reported Michael D. Frakes, PhD, of Duke University, Durham, N.C., and colleagues. The study findings stand in opposition to the “widely prevailing view” that information and medical knowledge among patients are integral to realizing high-quality, low-cost health care, the investigators noted.

“[This] research is particularly relevant to modern discussions and debates about the consumer-driven health care movement and the use of plans with high deductibles and high copayments to encourage greater patient and consumer involvement in health care decision making,” Dr. Frakes said in an interview. “Recent research has suggested that the financial incentives created by such structures discourage the use of both low-value care and high-value care. Some have argued that greater disclosure of information to patients may address this concern and steer patients towards high-value decisions. Our results cast doubt on the potential for information initiatives alone to meet this aim.”

The study is one of the first of its kind, the investigators noted in the National Bureau of Economic Research working paper. Other than a 2016 publication that found that physician mothers were less likely to have cesarean sections (Am Econ J: Econ Policy. 2016;8[1]:115-41), “there is no work which has been able to study the role of physicians as patients,” they wrote.

To fill this gap, the investigators turned to a unique data source: The Military Health System, which provides insurance to active and retired military personnel and their families. Military Health System spending exceeds $50 billion per year, constituting a major portion of American health care expenditures, and with more than 35,000 military physicians treated as patients, the dataset is highly relevant and powerful. The investigators objectively evaluated health outcomes by focusing on evidence-based, measurable clinical decisions deemed “high value” or “low value,” comparing how the frequency of these choices related with physician versus nonphysician patient status.

Coauthor Jonathan Gruber, PhD, of the Massachusetts Institute of Technology in Cambridge, Mass., explained this methodology in an interview. “The literature is clear that high-value care has positive health outcomes with relatively small increases in health care spending, and that low-value care has no impact on health outcomes with large increases in spending.”

“One concern with this analysis, of course, is that physicians may be of different health statuses and have different tastes for medical interventions than nonphysicians,” the investigators wrote. They addressed this problem in five ways, by focusing on widely accepted medical standards that apply to all patients; examining both high- and low-value care to eliminate one-sided bias; controlling for underlying health differences across groups; comparing physicians with other military officers to account for underlying tastes; and evaluating military officer dependents in comparison with physician dependents, the latter of whom may benefit from medical knowledge by virtue of personal relationship.

“Our results suggest that physicians do only slightly better than nonphysicians,” the investigators wrote, “but not by much and not always.” Low-value care was slightly less common among physicians, but this difference was described as “modest.” Analysis of high-value care was more mixed, with some results supporting equivalence between groups and others pointing to a slightly higher rate of high-value care among physician patients.

“These results provide a rough boundary on the extent to which additional information disclosure [beyond prevailing levels] can be expected to improve the delivery of health care in the U.S.,” the investigators wrote. “[M]ost of the explanation behind the over- and underutilization of low- and high-value services likely arises from factors other than informational deficiencies of patients.”

“Perhaps one interpretation of these findings is that patients remain generally deferential to the care recommendations of their treating physicians, even in the case of near fully informed patients,” the investigators wrote, noting that this interpretation aligns with a recent working paper that found that physicians play a greater role in selecting the site of MRI scans than patient cost-sharing factors.

Looking to the future, Dr. Gruber said that he and his colleagues plan on exploring “what drives this lack of response among physicians [as patients].”

The study was funded by the National Institute on Aging. The investigators reported no conflicts of interest.

SOURCE: Frakes MD et al. Natl Bur Econ Res. 2019 Jul. doi: 10.3386/w26038.

This article was updated 8/6/19.

TORONTO – A multimodal occupational therapy intervention in patients with thumb base osteoarthritis brought clinically meaningful improvements in pain, grip strength, and function, at least short term, in a Norwegian multicenter randomized clinical trial, Anne Therese Tveter reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

OA of the thumb base – that is, the carpometacarpal joint – causes more pain and dysfunction than disease involvement at many other sites because of the evolutionary importance of the opposable thumb. Current guidelines recommend conservative therapies as first line for hand OA; however, there is a dearth of high-quality evidence for multimodal occupational therapy in the special setting of thumb-base OA. This was the impetus for a randomized trial of 170 consecutive patients with thumb OA who presented to three Norwegian rheumatology departments for surgical consultation, explained Ms. Tveter, a physiotherapist at the Norwegian National Advisory Unit on Rehabilitation in Rheumatology at Diakonhjemmet Hospital in Oslo.

Participants were randomized to a 3-month, multimodal self-management intervention. It included education about OA; ergonomic principles; the importance of using separate orthoses as much as possible both day and night to stabilize the joint, improve performance, and relieve pain; and – at the heart of the program – instruction in hand exercises to enhance joint mobility, strength, and stability, as well as hand-stretching exercises. The exercises were to be done at home three times per week. Also, the active intervention group received five common assistive devices to help them in household tasks, such as opening jars. The control group received usual care, which was basically information about hand OA, she said at the meeting sponsored by the Osteoarthritis Research Society International.

Ms. Tveter presented an interim analysis focused on the 3-month outcomes. At 4 months, participants underwent surgical consultation. The study will continue for 2 years, with endpoints including the impact of the occupational therapy intervention on need for joint surgery, as well as long-term pain and function measures.

At baseline, most patients reported mild pain, with a median score of 3 on a 10-point numeric rating scale, and moderate disability. Baseline grip and pinch strength was 60%-65% of normal. The 3-month outcomes included pain at rest and during pinch- and grip-strength testing, range of motion through palmar abduction and abduction in the carpometacarpal joint, and self-reported function as measured using the validated MAP-Hand and QuickDASH physiotherapy measures. Adherence to the program was assessed by review of patient diaries.

At 3 months of follow-up, the active-intervention group showed significant improvements in all measures of pain and function except for the flexion deficit, which was minimal to begin with. In contrast, the control group showed no improvements and a trend towards deterioration in pain and function.

Specifically, the intervention group averaged a 1.4-point reduction in pain at rest on a self-reported 10-point scale, a 1.1-point improvement in pain following a grip strength test, and a 0.8-point improvement in pain following a pinch test. On the MAP-Hand self-reported test of function, the intervention group showed a 0.18-point improvement from a baseline of 2 on the 1-4 scale, coupled with an 8.1-point improvement on the QuickDASH, which is scored 0-100.

Adherence to the program was deemed acceptable: 82% of patients reported doing their hand exercises at least twice per week for at least 8 of the 12 weeks, 61% used their day orthotic devices at least 4 days per week for 8 weeks, 54% used the night orthoses at least 5 nights per week for 8 weeks, and 69% utilized at least three of the five home-assist devices. In total, 64% of patients adhered to at least three of the four program components.

Asked for the rationale in requesting that patients do their home exercises three times per week instead of daily, Ms. Tveter replied that three times per week is more realistic and is consistent with major guidelines.

“It would be nice to exercise every day. I don’t think it would be possible to get adherence to that,” she said.

She reported having no financial conflicts regarding the study, funded by scientific research grants from the Norwegian government.

bjancin@mdedge.com

TORONTO – A multimodal occupational therapy intervention in patients with thumb base osteoarthritis brought clinically meaningful improvements in pain, grip strength, and function, at least short term, in a Norwegian multicenter randomized clinical trial, Anne Therese Tveter reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

OA of the thumb base – that is, the carpometacarpal joint – causes more pain and dysfunction than disease involvement at many other sites because of the evolutionary importance of the opposable thumb. Current guidelines recommend conservative therapies as first line for hand OA; however, there is a dearth of high-quality evidence for multimodal occupational therapy in the special setting of thumb-base OA. This was the impetus for a randomized trial of 170 consecutive patients with thumb OA who presented to three Norwegian rheumatology departments for surgical consultation, explained Ms. Tveter, a physiotherapist at the Norwegian National Advisory Unit on Rehabilitation in Rheumatology at Diakonhjemmet Hospital in Oslo.

Participants were randomized to a 3-month, multimodal self-management intervention. It included education about OA; ergonomic principles; the importance of using separate orthoses as much as possible both day and night to stabilize the joint, improve performance, and relieve pain; and – at the heart of the program – instruction in hand exercises to enhance joint mobility, strength, and stability, as well as hand-stretching exercises. The exercises were to be done at home three times per week. Also, the active intervention group received five common assistive devices to help them in household tasks, such as opening jars. The control group received usual care, which was basically information about hand OA, she said at the meeting sponsored by the Osteoarthritis Research Society International.

Ms. Tveter presented an interim analysis focused on the 3-month outcomes. At 4 months, participants underwent surgical consultation. The study will continue for 2 years, with endpoints including the impact of the occupational therapy intervention on need for joint surgery, as well as long-term pain and function measures.

At baseline, most patients reported mild pain, with a median score of 3 on a 10-point numeric rating scale, and moderate disability. Baseline grip and pinch strength was 60%-65% of normal. The 3-month outcomes included pain at rest and during pinch- and grip-strength testing, range of motion through palmar abduction and abduction in the carpometacarpal joint, and self-reported function as measured using the validated MAP-Hand and QuickDASH physiotherapy measures. Adherence to the program was assessed by review of patient diaries.

At 3 months of follow-up, the active-intervention group showed significant improvements in all measures of pain and function except for the flexion deficit, which was minimal to begin with. In contrast, the control group showed no improvements and a trend towards deterioration in pain and function.

Specifically, the intervention group averaged a 1.4-point reduction in pain at rest on a self-reported 10-point scale, a 1.1-point improvement in pain following a grip strength test, and a 0.8-point improvement in pain following a pinch test. On the MAP-Hand self-reported test of function, the intervention group showed a 0.18-point improvement from a baseline of 2 on the 1-4 scale, coupled with an 8.1-point improvement on the QuickDASH, which is scored 0-100.

Adherence to the program was deemed acceptable: 82% of patients reported doing their hand exercises at least twice per week for at least 8 of the 12 weeks, 61% used their day orthotic devices at least 4 days per week for 8 weeks, 54% used the night orthoses at least 5 nights per week for 8 weeks, and 69% utilized at least three of the five home-assist devices. In total, 64% of patients adhered to at least three of the four program components.

Asked for the rationale in requesting that patients do their home exercises three times per week instead of daily, Ms. Tveter replied that three times per week is more realistic and is consistent with major guidelines.

“It would be nice to exercise every day. I don’t think it would be possible to get adherence to that,” she said.

She reported having no financial conflicts regarding the study, funded by scientific research grants from the Norwegian government.

bjancin@mdedge.com

TORONTO – A multimodal occupational therapy intervention in patients with thumb base osteoarthritis brought clinically meaningful improvements in pain, grip strength, and function, at least short term, in a Norwegian multicenter randomized clinical trial, Anne Therese Tveter reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

OA of the thumb base – that is, the carpometacarpal joint – causes more pain and dysfunction than disease involvement at many other sites because of the evolutionary importance of the opposable thumb. Current guidelines recommend conservative therapies as first line for hand OA; however, there is a dearth of high-quality evidence for multimodal occupational therapy in the special setting of thumb-base OA. This was the impetus for a randomized trial of 170 consecutive patients with thumb OA who presented to three Norwegian rheumatology departments for surgical consultation, explained Ms. Tveter, a physiotherapist at the Norwegian National Advisory Unit on Rehabilitation in Rheumatology at Diakonhjemmet Hospital in Oslo.

Participants were randomized to a 3-month, multimodal self-management intervention. It included education about OA; ergonomic principles; the importance of using separate orthoses as much as possible both day and night to stabilize the joint, improve performance, and relieve pain; and – at the heart of the program – instruction in hand exercises to enhance joint mobility, strength, and stability, as well as hand-stretching exercises. The exercises were to be done at home three times per week. Also, the active intervention group received five common assistive devices to help them in household tasks, such as opening jars. The control group received usual care, which was basically information about hand OA, she said at the meeting sponsored by the Osteoarthritis Research Society International.

Ms. Tveter presented an interim analysis focused on the 3-month outcomes. At 4 months, participants underwent surgical consultation. The study will continue for 2 years, with endpoints including the impact of the occupational therapy intervention on need for joint surgery, as well as long-term pain and function measures.

At baseline, most patients reported mild pain, with a median score of 3 on a 10-point numeric rating scale, and moderate disability. Baseline grip and pinch strength was 60%-65% of normal. The 3-month outcomes included pain at rest and during pinch- and grip-strength testing, range of motion through palmar abduction and abduction in the carpometacarpal joint, and self-reported function as measured using the validated MAP-Hand and QuickDASH physiotherapy measures. Adherence to the program was assessed by review of patient diaries.

At 3 months of follow-up, the active-intervention group showed significant improvements in all measures of pain and function except for the flexion deficit, which was minimal to begin with. In contrast, the control group showed no improvements and a trend towards deterioration in pain and function.

Specifically, the intervention group averaged a 1.4-point reduction in pain at rest on a self-reported 10-point scale, a 1.1-point improvement in pain following a grip strength test, and a 0.8-point improvement in pain following a pinch test. On the MAP-Hand self-reported test of function, the intervention group showed a 0.18-point improvement from a baseline of 2 on the 1-4 scale, coupled with an 8.1-point improvement on the QuickDASH, which is scored 0-100.

Adherence to the program was deemed acceptable: 82% of patients reported doing their hand exercises at least twice per week for at least 8 of the 12 weeks, 61% used their day orthotic devices at least 4 days per week for 8 weeks, 54% used the night orthoses at least 5 nights per week for 8 weeks, and 69% utilized at least three of the five home-assist devices. In total, 64% of patients adhered to at least three of the four program components.

Asked for the rationale in requesting that patients do their home exercises three times per week instead of daily, Ms. Tveter replied that three times per week is more realistic and is consistent with major guidelines.

“It would be nice to exercise every day. I don’t think it would be possible to get adherence to that,” she said.

She reported having no financial conflicts regarding the study, funded by scientific research grants from the Norwegian government.

bjancin@mdedge.com

AUSTIN, TEX. – One day each week, Sasha D. Jaquez, PhD, visits with patients in the dermatology clinic at Dell Children’s Medical Center of Central Texas who wrestle with some aspect of their skin condition, from noncompliance to a recommended treatment regimen to fear of needles when an injection of medicine is required to keep them well.

“Our goal is to help promote the health and development of children, adolescents, and families through the use of evidence-based methods like cognitive-behavioral therapy,” said Dr. Jaquez, who is a pediatric psychologist at the University of Texas, Austin. “We do assessment and treatment of behavioral and emotional difficulties related to their skin condition or medical condition. So if they’re depressed but it’s not related to their skin condition, we will likely refer the patient to a community mental health system.”

During 1-hour visits at the dermatology clinic, Dr. Jaquez uses a mixed approach that includes cognitive-behavioral therapy and motivational interviewing to help patients and family members cope with their problematic behavior or negative thought patterns related to their skin conditions. “We do not have magic wands; we focus on the here and now,” she explained. “We focus on how to move forward in the most efficient way possible by teaching skills, practicing those skills with them in the office, and sending them home to use those skills. I don’t have 100% compliance on this, so if I notice that they’re not doing what I asked of them, we’ll have a conversation about what the barrier is. ‘What is getting in the way?’ I’ll ask. ‘Is this something you’re really wanting, or do you want a magic pill? If you want a magic pill, then our office isn’t where that’s going to come from.’ Sometimes patients aren’t ready to work on feeling better, and that is good for us to know.”

During consultations, she often talks with children and adolescents about how thoughts, feelings, and behaviors are related. She’ll use phrasing like, “The way that you think about something changes the way that you feel, and it changes the way that you act. We have control over our thoughts and behaviors, so if we think it’s going to be a bad day, it’s going to be a bad day. If we think it’s going to be a good day, then we’re going to find the positive aspects in the day and we might let those bad aspects go away. If I do something different [for my skin condition], then I’m going to feel different.”

She recalled the case of a 3-year-old boy with atopic dermatitis who was referred for excessive scratching. His mom stays at home, while dad works and travels frequently. “The parents had differing views on how to treat his medical condition. Mom wanted to do wet wraps while dad wanted to do bleach baths. Their son was getting no treatment because the parents couldn’t agree on anything. Mom noticed that her son scratches when he wants attention and when he’s angry.”

When Dr. Jaquez met with his parents, she encouraged them to agree on a plan to implement at home so that their son would gain some relief. She also advised them to ignore when their son scratches or when he gets angry. “Give him something else to do besides scratch, because if those hands are busy, he won’t be scratching. Let’s change the way this behavior happens. Let’s give him attention all the time instead of just when he’s scratching. That will work very quickly. And it did.”

She makes it a point to talk with patients and their families about living with the stress of a chronic illness like psoriasis or atopic dermatitis. “Let’s figure out, ‘How do we accept that this is how it is, and that they’re going to have to find their own ‘normal?’ ” she said. “I don’t know how many times someone comes into my office and says, ‘I just want to be normal.’ I like to ask patients, ‘what is your normal?’ These kids might have a lower quality of life than a child without a chronic illness, but we want to make sure that they’re living their lives to the fullest. You want to monitor not only adherence [to medication] but also quality of life. Sleep concerns are big. A lot of our kids might not being going to school, or they’re afraid to go to school because they get picked on because people don’t understand their skin condition.”

Dr. Jaquez acknowledged that not all dermatologists have a psychologist on staff or in their referral network, but all are capable of destigmatizing psychological and mental health issues for their patients. “Psychological comorbidities such as depression and anxiety can be associated with certain skin conditions,” she said. “Let them know that this is stressful stuff. Have discussions early, so if the time comes for a referral they won’t think you’re giving up on them. Don’t be afraid to say you have a psychologist that you want to refer to. Say, ‘I have an added team member I would love for you to meet. She’s our psychologist. She works with patients who are having difficulties.’ ”

Giving patients perceived control of their care could also help improve the behavior of concern. For example, when patients with needle phobia require an injection, ask if they would like to lay down, or sit down for the injection. “Giving them this tiny bit of control is going to help them feel more empowered,” she said.

Dr. Jaquez also recommends that clinicians pay attention to nonverbal cues and steer clear of using scare tactics to change their behavior. “Use positive behavioral strategies and try to avoid punishment. Children don’t want to hear ‘stop’ all the time. Parents are tired of saying it, and kids are tired of hearing it. We focus on praising the things that are going well. I advise parents all the time: ‘Catch them being good.’ ”

Dr. Jaquez reported having no financial disclosures.

dbrunk@mdedge.com

AUSTIN, TEX. – One day each week, Sasha D. Jaquez, PhD, visits with patients in the dermatology clinic at Dell Children’s Medical Center of Central Texas who wrestle with some aspect of their skin condition, from noncompliance to a recommended treatment regimen to fear of needles when an injection of medicine is required to keep them well.

“Our goal is to help promote the health and development of children, adolescents, and families through the use of evidence-based methods like cognitive-behavioral therapy,” said Dr. Jaquez, who is a pediatric psychologist at the University of Texas, Austin. “We do assessment and treatment of behavioral and emotional difficulties related to their skin condition or medical condition. So if they’re depressed but it’s not related to their skin condition, we will likely refer the patient to a community mental health system.”

During 1-hour visits at the dermatology clinic, Dr. Jaquez uses a mixed approach that includes cognitive-behavioral therapy and motivational interviewing to help patients and family members cope with their problematic behavior or negative thought patterns related to their skin conditions. “We do not have magic wands; we focus on the here and now,” she explained. “We focus on how to move forward in the most efficient way possible by teaching skills, practicing those skills with them in the office, and sending them home to use those skills. I don’t have 100% compliance on this, so if I notice that they’re not doing what I asked of them, we’ll have a conversation about what the barrier is. ‘What is getting in the way?’ I’ll ask. ‘Is this something you’re really wanting, or do you want a magic pill? If you want a magic pill, then our office isn’t where that’s going to come from.’ Sometimes patients aren’t ready to work on feeling better, and that is good for us to know.”

During consultations, she often talks with children and adolescents about how thoughts, feelings, and behaviors are related. She’ll use phrasing like, “The way that you think about something changes the way that you feel, and it changes the way that you act. We have control over our thoughts and behaviors, so if we think it’s going to be a bad day, it’s going to be a bad day. If we think it’s going to be a good day, then we’re going to find the positive aspects in the day and we might let those bad aspects go away. If I do something different [for my skin condition], then I’m going to feel different.”

She recalled the case of a 3-year-old boy with atopic dermatitis who was referred for excessive scratching. His mom stays at home, while dad works and travels frequently. “The parents had differing views on how to treat his medical condition. Mom wanted to do wet wraps while dad wanted to do bleach baths. Their son was getting no treatment because the parents couldn’t agree on anything. Mom noticed that her son scratches when he wants attention and when he’s angry.”

When Dr. Jaquez met with his parents, she encouraged them to agree on a plan to implement at home so that their son would gain some relief. She also advised them to ignore when their son scratches or when he gets angry. “Give him something else to do besides scratch, because if those hands are busy, he won’t be scratching. Let’s change the way this behavior happens. Let’s give him attention all the time instead of just when he’s scratching. That will work very quickly. And it did.”

She makes it a point to talk with patients and their families about living with the stress of a chronic illness like psoriasis or atopic dermatitis. “Let’s figure out, ‘How do we accept that this is how it is, and that they’re going to have to find their own ‘normal?’ ” she said. “I don’t know how many times someone comes into my office and says, ‘I just want to be normal.’ I like to ask patients, ‘what is your normal?’ These kids might have a lower quality of life than a child without a chronic illness, but we want to make sure that they’re living their lives to the fullest. You want to monitor not only adherence [to medication] but also quality of life. Sleep concerns are big. A lot of our kids might not being going to school, or they’re afraid to go to school because they get picked on because people don’t understand their skin condition.”

Dr. Jaquez acknowledged that not all dermatologists have a psychologist on staff or in their referral network, but all are capable of destigmatizing psychological and mental health issues for their patients. “Psychological comorbidities such as depression and anxiety can be associated with certain skin conditions,” she said. “Let them know that this is stressful stuff. Have discussions early, so if the time comes for a referral they won’t think you’re giving up on them. Don’t be afraid to say you have a psychologist that you want to refer to. Say, ‘I have an added team member I would love for you to meet. She’s our psychologist. She works with patients who are having difficulties.’ ”

Giving patients perceived control of their care could also help improve the behavior of concern. For example, when patients with needle phobia require an injection, ask if they would like to lay down, or sit down for the injection. “Giving them this tiny bit of control is going to help them feel more empowered,” she said.

Dr. Jaquez also recommends that clinicians pay attention to nonverbal cues and steer clear of using scare tactics to change their behavior. “Use positive behavioral strategies and try to avoid punishment. Children don’t want to hear ‘stop’ all the time. Parents are tired of saying it, and kids are tired of hearing it. We focus on praising the things that are going well. I advise parents all the time: ‘Catch them being good.’ ”

Dr. Jaquez reported having no financial disclosures.

dbrunk@mdedge.com

AUSTIN, TEX. – One day each week, Sasha D. Jaquez, PhD, visits with patients in the dermatology clinic at Dell Children’s Medical Center of Central Texas who wrestle with some aspect of their skin condition, from noncompliance to a recommended treatment regimen to fear of needles when an injection of medicine is required to keep them well.

“Our goal is to help promote the health and development of children, adolescents, and families through the use of evidence-based methods like cognitive-behavioral therapy,” said Dr. Jaquez, who is a pediatric psychologist at the University of Texas, Austin. “We do assessment and treatment of behavioral and emotional difficulties related to their skin condition or medical condition. So if they’re depressed but it’s not related to their skin condition, we will likely refer the patient to a community mental health system.”

During 1-hour visits at the dermatology clinic, Dr. Jaquez uses a mixed approach that includes cognitive-behavioral therapy and motivational interviewing to help patients and family members cope with their problematic behavior or negative thought patterns related to their skin conditions. “We do not have magic wands; we focus on the here and now,” she explained. “We focus on how to move forward in the most efficient way possible by teaching skills, practicing those skills with them in the office, and sending them home to use those skills. I don’t have 100% compliance on this, so if I notice that they’re not doing what I asked of them, we’ll have a conversation about what the barrier is. ‘What is getting in the way?’ I’ll ask. ‘Is this something you’re really wanting, or do you want a magic pill? If you want a magic pill, then our office isn’t where that’s going to come from.’ Sometimes patients aren’t ready to work on feeling better, and that is good for us to know.”

During consultations, she often talks with children and adolescents about how thoughts, feelings, and behaviors are related. She’ll use phrasing like, “The way that you think about something changes the way that you feel, and it changes the way that you act. We have control over our thoughts and behaviors, so if we think it’s going to be a bad day, it’s going to be a bad day. If we think it’s going to be a good day, then we’re going to find the positive aspects in the day and we might let those bad aspects go away. If I do something different [for my skin condition], then I’m going to feel different.”

She recalled the case of a 3-year-old boy with atopic dermatitis who was referred for excessive scratching. His mom stays at home, while dad works and travels frequently. “The parents had differing views on how to treat his medical condition. Mom wanted to do wet wraps while dad wanted to do bleach baths. Their son was getting no treatment because the parents couldn’t agree on anything. Mom noticed that her son scratches when he wants attention and when he’s angry.”

When Dr. Jaquez met with his parents, she encouraged them to agree on a plan to implement at home so that their son would gain some relief. She also advised them to ignore when their son scratches or when he gets angry. “Give him something else to do besides scratch, because if those hands are busy, he won’t be scratching. Let’s change the way this behavior happens. Let’s give him attention all the time instead of just when he’s scratching. That will work very quickly. And it did.”

She makes it a point to talk with patients and their families about living with the stress of a chronic illness like psoriasis or atopic dermatitis. “Let’s figure out, ‘How do we accept that this is how it is, and that they’re going to have to find their own ‘normal?’ ” she said. “I don’t know how many times someone comes into my office and says, ‘I just want to be normal.’ I like to ask patients, ‘what is your normal?’ These kids might have a lower quality of life than a child without a chronic illness, but we want to make sure that they’re living their lives to the fullest. You want to monitor not only adherence [to medication] but also quality of life. Sleep concerns are big. A lot of our kids might not being going to school, or they’re afraid to go to school because they get picked on because people don’t understand their skin condition.”

Dr. Jaquez acknowledged that not all dermatologists have a psychologist on staff or in their referral network, but all are capable of destigmatizing psychological and mental health issues for their patients. “Psychological comorbidities such as depression and anxiety can be associated with certain skin conditions,” she said. “Let them know that this is stressful stuff. Have discussions early, so if the time comes for a referral they won’t think you’re giving up on them. Don’t be afraid to say you have a psychologist that you want to refer to. Say, ‘I have an added team member I would love for you to meet. She’s our psychologist. She works with patients who are having difficulties.’ ”

Giving patients perceived control of their care could also help improve the behavior of concern. For example, when patients with needle phobia require an injection, ask if they would like to lay down, or sit down for the injection. “Giving them this tiny bit of control is going to help them feel more empowered,” she said.

Dr. Jaquez also recommends that clinicians pay attention to nonverbal cues and steer clear of using scare tactics to change their behavior. “Use positive behavioral strategies and try to avoid punishment. Children don’t want to hear ‘stop’ all the time. Parents are tired of saying it, and kids are tired of hearing it. We focus on praising the things that are going well. I advise parents all the time: ‘Catch them being good.’ ”

Dr. Jaquez reported having no financial disclosures.

dbrunk@mdedge.com

TORONTO – A single intra-articular injection of a novel, sustained-release liposomal formulation of dexamethasone in patients with symptomatic knee osteoarthritis brought at least 6 months of pain control in a multicenter, phase 2a trial, David Hunter, MD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

This is a product that could fill a significant unmet medical need. Current therapies for knee OA have modest efficacy, and the injectable ones provide only 2-4 weeks of benefit. The ability to obtain significant pain relief with just a couple of intra-articular injections per year would be an important therapeutic advance, observed Dr. Hunter, professor of medicine at the University of Sydney.

He presented a 24-week study of 75 patients with symptomatic knee OA randomized at 13 sites in Australia and Taiwan to a single intra-articular injection of either 12 or 18 mg of the liposomal dexamethasone or to normal saline. One knee per patient was treated.

The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 12. The 12-mg formulation of steroid significantly outperformed placebo at that time point as well as at all others. From a mean baseline WOMAC pain score of 1.49 on the 0-4 scale, patients in the 12-mg group averaged reductions of 0.83 points at 12 weeks, 0.85 at both weeks 16 and 20, and 0.87 at week 24. A statistically significant between-group difference was seen as early as day 3 after injection.

More than half (52%) of recipients of the 12-mg dose of liposomal dexamethasone, a product known for now simply as TLC599, maintained at least 30% pain relief at all visits through the study close at 24 weeks, as did 22% of controls, the rheumatologist reported at the meeting sponsored by the Osteoarthritis Research Society International.

The 12-mg injection also proved superior to placebo for the secondary endpoint of change in WOMAC function score. From a mean baseline score of 1.53, recipients of the 12-mg dose had improvements ranging from 0.82 points at week 12 to 0.85 points at week 24.

Of note, total acetaminophen intake over the course of the trial in the 12-mg steroid group was less than one-third of that in controls.

The 18-mg dose didn’t result in significantly greater reduction in pain scores than placebo. This is because dexamethasone release in the higher-dose formulation as presently constituted turned out to be less efficient, Dr. Hunter explained.

The safety profile was closely similar in all three study arms.

In phase 3 clinical trials, TLC599 will be compared with standard intra-articular triamcinolone, according to the rheumatologist.

He reported serving as a consultant to the Taiwan Liposome Company, which sponsored the phase 2a study, as well as to a handful of other pharmaceutical companies.

bjancin@mdedge.com

TORONTO – A single intra-articular injection of a novel, sustained-release liposomal formulation of dexamethasone in patients with symptomatic knee osteoarthritis brought at least 6 months of pain control in a multicenter, phase 2a trial, David Hunter, MD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

This is a product that could fill a significant unmet medical need. Current therapies for knee OA have modest efficacy, and the injectable ones provide only 2-4 weeks of benefit. The ability to obtain significant pain relief with just a couple of intra-articular injections per year would be an important therapeutic advance, observed Dr. Hunter, professor of medicine at the University of Sydney.

He presented a 24-week study of 75 patients with symptomatic knee OA randomized at 13 sites in Australia and Taiwan to a single intra-articular injection of either 12 or 18 mg of the liposomal dexamethasone or to normal saline. One knee per patient was treated.

The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 12. The 12-mg formulation of steroid significantly outperformed placebo at that time point as well as at all others. From a mean baseline WOMAC pain score of 1.49 on the 0-4 scale, patients in the 12-mg group averaged reductions of 0.83 points at 12 weeks, 0.85 at both weeks 16 and 20, and 0.87 at week 24. A statistically significant between-group difference was seen as early as day 3 after injection.

More than half (52%) of recipients of the 12-mg dose of liposomal dexamethasone, a product known for now simply as TLC599, maintained at least 30% pain relief at all visits through the study close at 24 weeks, as did 22% of controls, the rheumatologist reported at the meeting sponsored by the Osteoarthritis Research Society International.

The 12-mg injection also proved superior to placebo for the secondary endpoint of change in WOMAC function score. From a mean baseline score of 1.53, recipients of the 12-mg dose had improvements ranging from 0.82 points at week 12 to 0.85 points at week 24.

Of note, total acetaminophen intake over the course of the trial in the 12-mg steroid group was less than one-third of that in controls.

The 18-mg dose didn’t result in significantly greater reduction in pain scores than placebo. This is because dexamethasone release in the higher-dose formulation as presently constituted turned out to be less efficient, Dr. Hunter explained.

The safety profile was closely similar in all three study arms.

In phase 3 clinical trials, TLC599 will be compared with standard intra-articular triamcinolone, according to the rheumatologist.

He reported serving as a consultant to the Taiwan Liposome Company, which sponsored the phase 2a study, as well as to a handful of other pharmaceutical companies.

bjancin@mdedge.com

TORONTO – A single intra-articular injection of a novel, sustained-release liposomal formulation of dexamethasone in patients with symptomatic knee osteoarthritis brought at least 6 months of pain control in a multicenter, phase 2a trial, David Hunter, MD, reported at the OARSI 2019 World Congress.

Bruce Jancin/MDedge News

This is a product that could fill a significant unmet medical need. Current therapies for knee OA have modest efficacy, and the injectable ones provide only 2-4 weeks of benefit. The ability to obtain significant pain relief with just a couple of intra-articular injections per year would be an important therapeutic advance, observed Dr. Hunter, professor of medicine at the University of Sydney.

He presented a 24-week study of 75 patients with symptomatic knee OA randomized at 13 sites in Australia and Taiwan to a single intra-articular injection of either 12 or 18 mg of the liposomal dexamethasone or to normal saline. One knee per patient was treated.

The primary outcome was the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 12. The 12-mg formulation of steroid significantly outperformed placebo at that time point as well as at all others. From a mean baseline WOMAC pain score of 1.49 on the 0-4 scale, patients in the 12-mg group averaged reductions of 0.83 points at 12 weeks, 0.85 at both weeks 16 and 20, and 0.87 at week 24. A statistically significant between-group difference was seen as early as day 3 after injection.

More than half (52%) of recipients of the 12-mg dose of liposomal dexamethasone, a product known for now simply as TLC599, maintained at least 30% pain relief at all visits through the study close at 24 weeks, as did 22% of controls, the rheumatologist reported at the meeting sponsored by the Osteoarthritis Research Society International.

The 12-mg injection also proved superior to placebo for the secondary endpoint of change in WOMAC function score. From a mean baseline score of 1.53, recipients of the 12-mg dose had improvements ranging from 0.82 points at week 12 to 0.85 points at week 24.

Of note, total acetaminophen intake over the course of the trial in the 12-mg steroid group was less than one-third of that in controls.

The 18-mg dose didn’t result in significantly greater reduction in pain scores than placebo. This is because dexamethasone release in the higher-dose formulation as presently constituted turned out to be less efficient, Dr. Hunter explained.

The safety profile was closely similar in all three study arms.

In phase 3 clinical trials, TLC599 will be compared with standard intra-articular triamcinolone, according to the rheumatologist.

He reported serving as a consultant to the Taiwan Liposome Company, which sponsored the phase 2a study, as well as to a handful of other pharmaceutical companies.

bjancin@mdedge.com

AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.

However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.

“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”

In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.

A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.

Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).

“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”

She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”

She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.

The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.

dbrunk@mdedge.com

AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.

However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.

“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”

In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.

A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.

Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).

“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”

She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”

She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.

The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.

dbrunk@mdedge.com

AUSTIN, TEX. – Among children with psoriasis, there appears to be no strong evidence that biologic immunomodulating drugs increase the 6-month risk of serious infections, compared with systemic nonbiologics or phototherapy, according to results from the largest population-based study of its kind to date.

However, children with psoriasis face a 64% increased risk of infection, compared with risk-matched pediatric patients without the disease.

“We know that pediatric psoriasis affects up to 1.3% of children, and we know that is associated with multiple potential comorbidities and that it has a significant impact on quality of life for children affected,” lead study author Maria Schneeweiss, MD, said at the annual meeting of the Society for Pediatric Dermatology. “Increasingly, we see that biologic and nonbiologic systemic agents are used to treat moderate to severe pediatric psoriasis. While we have a lot of experience in adult psoriasis and a lot of comparative safety studies of these drugs in adult psoriasis, there are very few population-based studies on the safety of these systemic agents for treating pediatric psoriasis.”

In an effort to evaluate the 6-month risk of serious bacterial and opportunistic infections in children with psoriasis treated with systemic immunomodulatory medications, Dr. Schneeweiss and Joseph F. Merola, MD, of the department of dermatology at Brigham and Women’s Hospital, Boston, and Jennifer Huang, MD, of Boston Children’s Hospital drew from longitudinal, patient-level U.S. claims data in the MarketScan database between 2003 and 2017. They limited the analysis to patients younger than age 18; those who had a recorded diagnosis of psoriasis; and those who were treated with biologics, nonbiologic immunomodulatory agents, or phototherapy. The researchers used hospital discharge diagnoses to compute the risk of serious bacterial and opportunistic infections, and propensity score matching to determine relative risks.

A total of 54,355 children with psoriasis were identified in the database. Before propensity score matching, 635 patients initiated biologic therapy, 919 initiated nonbiologic systemic agents, and 2,537 initiated phototherapy. Their mean age was 12-14 years and slightly more than half were female. In nonbiologic initiators, the 6-month risk of serious infections was 4.75 per 1,000 patients, while in biologic initiators it was 5.44 per 1,000 patients, resulting in a propensity score–matched ratio of 0.60. There was no statistically significant increased risk when the use of nonbiologics was compared with the use of phototherapy.

Independent of treatment, the risk of infection among psoriasis patients was 1.1 per 1,000 patients, which was 60% higher than matched pediatric patients without psoriasis (risk ratio, 1.64).

“When treating pediatric patients with psoriasis, clinicians should remain mindful that the presence of psoriasis itself may increase the risk of infection in children and adolescents, independent of treatment, but that biologic immunomodulatory agents do not further increase that risk,” Dr. Schneeweiss said in an interview. “Our findings suggest that, while there may be an increased risk of certain infections based on the presence of psoriasis alone, all appropriate treatment options should be discussed with patients in shared decision making with their physician. Patients should understand the risks, benefits, and alternatives to any treatment option but not necessarily be restricted as such and have access to newer, targeted and highly effective therapy as appropriate to each individual case.”

She added that, based on the National Psoriasis Foundation guidance of treat-to-target strategies, “our pediatric patients should be offered the same level of disease control as all psoriasis patients.”

She acknowledged certain limitations of the analysis, including the inability to stratify by disease severity and to determine specific doses of medication used.

The study was funded by the Brigham and Women’s Hospital departments of dermatology and medicine. Dr. Schneeweiss and Dr. Huang reported having no financial disclosures. Dr. Merola reported that he has served as a consultant and/or investigator for numerous pharmaceutical companies.

dbrunk@mdedge.com