Psoriasis

COPENHAGEN – What can physicians and their psoriasis patients realistically expect from long-term apremilast therapy?

“I think the take-home number is a 50%-plus PASI-75 response after 1 year among patients with moderate to severe plaque psoriasis,” Dr. Kristian Reich said at the annual congress of the European Academy of Dermatology and Venereology.

He presented what he considers to be the first solid data addressing this key question. The data come from a new analysis of the 52-week results of the LIBERATE trial.

“Due to the randomized withdrawal design and long-term treatment only of responders in the original pivotal phase III ESTEEM program, I think we’ve had no real understanding from clinical trials of what the long-term efficacy of apremilast [Otezla] is. Of course, with psoriasis being a chronic disease, this is really what we want to know. And we can get this data very nicely from the LIBERATE study. I should point out that although LIBERATE is a relatively small study, every single patient is included here. So I think this is a very robust analysis of 1-year efficacy data,” said Dr. Reich, managing partner of Dermatologikum Hamburg (Germany).

In contrast to the inclusive analysis performed in LIBERATE, in the pivotal ESTEEM I trial a mere 77 of 562 psoriasis patients randomized to apremilast were on the oral phosphodiesterase type 4 inhibitor for the full 52-week study period, with 61% of that superselect subgroup showing a PASI-75 response (J Am Acad Dermatol. 2015 Jul;73[1]:37-49).

LIBERATE included 250 psoriasis patients. Their baseline Psoriasis Area and Severity Index (PASI) score was about 20, with 27% body surface area involved, a body mass index of 29 kg/m², 89 kg of body weight, and a mean Dermatology Life Quality Index (DLQI) score of 13. Seventy percent to 80% of subjects had previously used conventional systemic therapies, but no one was allowed to have prior use of biologic therapies.

Patients were randomized to one of three study arms: 16 weeks of oral apremilast at the approved dose of 30 mg twice daily plus a weekly placebo injection, subcutaneous etanercept (Enbrel) at 50 mg once weekly plus a placebo tablet, or dual placebos. At 16 weeks, all patients were switched to apremilast at 30 mg twice daily with no placebos through week 52.

The PASI-75 response rate at week 16 was 11.9% in the placebo group, 39.8% with apremilast, and 48.2% with etanercept.

“I am surprised to see in the more recent studies the high response to etanercept. This is fantastic data. Etanercept seems to ripen like old wine. It’s getting better the longer we have it,” the dermatologist commented.

The PASI-75 rates at 1 year were 46.4% with placebo/apremilast, 50.6% with apremilast throughout, and 55.4% with etanercept/apremilast.

The mean improvement in DLQI from baseline to 52 weeks – a secondary endpoint – was 6.6 points with placebo/apremilast, 8.0 with apremilast/apremilast, and 8.9 points with etanercept/apremilast. A noteworthy finding was that during the first 16 weeks apremilast brought a clinically meaningful improvement in quality of life significantly faster than etanercept did, with a significant difference seen between the two study arms even in the first 1-2 weeks.

The likely explanation for this benefit is that the mean reduction in pruritus visual analog scale scores was significantly greater with apremilast than etanercept through the first 8 weeks. Although pruritus is traditionally thought of more in the context of atopic dermatitis, it’s actually also the No. 1 complaint among psoriasis patients, according to Dr. Reich.

“This is a special thing with apremilast, that the pruritus really goes down very significantly early on. It raises an interesting question about what the role of phosphodiesterase-4 inhibition might be in pruritus. I couldn’t give you a molecular explanation, but I think because pruritus is so annoying and it definitely affects quality of life, this could be a possible explanation for why there is more rapid improvement in quality of life independent of the PASI improvement,” he said.

Switching from etanercept to apremilast didn’t result in any clinically significant safety findings through week 52. No meaningful laboratory changes occurred during 52 weeks of monitoring. There were no cases of suicidal ideation, no increase in serious infections, and only a single cardiac event. The most common apremilast-associated side effects seen in LIBERATE were loose stools in 8%-15% of patients, nausea in 10%, and headache in 13%. These adverse events were mild to moderate in nature and decreased in prevalence over time. The maximum weight loss noted over the course of 52 weeks occurred in the placebo-to-apremilast group, with a mean 1.3-kg reduction.

“I would call the LIBERATE results a validation of the earlier data showing a very clean safety profile with this drug,” Dr. Reich said.

This is reflected in the product labeling, which unlike other systemic therapies for psoriasis includes no requirements for laboratory monitoring or tuberculosis testing.

Both the LIBERATE and the ESTEEM trials were sponsored by Celgene. Dr. Reich received research grants as an investigator in both programs.

[email protected]

COPENHAGEN – What can physicians and their psoriasis patients realistically expect from long-term apremilast therapy?

“I think the take-home number is a 50%-plus PASI-75 response after 1 year among patients with moderate to severe plaque psoriasis,” Dr. Kristian Reich said at the annual congress of the European Academy of Dermatology and Venereology.

He presented what he considers to be the first solid data addressing this key question. The data come from a new analysis of the 52-week results of the LIBERATE trial.

“Due to the randomized withdrawal design and long-term treatment only of responders in the original pivotal phase III ESTEEM program, I think we’ve had no real understanding from clinical trials of what the long-term efficacy of apremilast [Otezla] is. Of course, with psoriasis being a chronic disease, this is really what we want to know. And we can get this data very nicely from the LIBERATE study. I should point out that although LIBERATE is a relatively small study, every single patient is included here. So I think this is a very robust analysis of 1-year efficacy data,” said Dr. Reich, managing partner of Dermatologikum Hamburg (Germany).

In contrast to the inclusive analysis performed in LIBERATE, in the pivotal ESTEEM I trial a mere 77 of 562 psoriasis patients randomized to apremilast were on the oral phosphodiesterase type 4 inhibitor for the full 52-week study period, with 61% of that superselect subgroup showing a PASI-75 response (J Am Acad Dermatol. 2015 Jul;73[1]:37-49).

LIBERATE included 250 psoriasis patients. Their baseline Psoriasis Area and Severity Index (PASI) score was about 20, with 27% body surface area involved, a body mass index of 29 kg/m², 89 kg of body weight, and a mean Dermatology Life Quality Index (DLQI) score of 13. Seventy percent to 80% of subjects had previously used conventional systemic therapies, but no one was allowed to have prior use of biologic therapies.

Patients were randomized to one of three study arms: 16 weeks of oral apremilast at the approved dose of 30 mg twice daily plus a weekly placebo injection, subcutaneous etanercept (Enbrel) at 50 mg once weekly plus a placebo tablet, or dual placebos. At 16 weeks, all patients were switched to apremilast at 30 mg twice daily with no placebos through week 52.

The PASI-75 response rate at week 16 was 11.9% in the placebo group, 39.8% with apremilast, and 48.2% with etanercept.

“I am surprised to see in the more recent studies the high response to etanercept. This is fantastic data. Etanercept seems to ripen like old wine. It’s getting better the longer we have it,” the dermatologist commented.

The PASI-75 rates at 1 year were 46.4% with placebo/apremilast, 50.6% with apremilast throughout, and 55.4% with etanercept/apremilast.

The mean improvement in DLQI from baseline to 52 weeks – a secondary endpoint – was 6.6 points with placebo/apremilast, 8.0 with apremilast/apremilast, and 8.9 points with etanercept/apremilast. A noteworthy finding was that during the first 16 weeks apremilast brought a clinically meaningful improvement in quality of life significantly faster than etanercept did, with a significant difference seen between the two study arms even in the first 1-2 weeks.

The likely explanation for this benefit is that the mean reduction in pruritus visual analog scale scores was significantly greater with apremilast than etanercept through the first 8 weeks. Although pruritus is traditionally thought of more in the context of atopic dermatitis, it’s actually also the No. 1 complaint among psoriasis patients, according to Dr. Reich.

“This is a special thing with apremilast, that the pruritus really goes down very significantly early on. It raises an interesting question about what the role of phosphodiesterase-4 inhibition might be in pruritus. I couldn’t give you a molecular explanation, but I think because pruritus is so annoying and it definitely affects quality of life, this could be a possible explanation for why there is more rapid improvement in quality of life independent of the PASI improvement,” he said.

Switching from etanercept to apremilast didn’t result in any clinically significant safety findings through week 52. No meaningful laboratory changes occurred during 52 weeks of monitoring. There were no cases of suicidal ideation, no increase in serious infections, and only a single cardiac event. The most common apremilast-associated side effects seen in LIBERATE were loose stools in 8%-15% of patients, nausea in 10%, and headache in 13%. These adverse events were mild to moderate in nature and decreased in prevalence over time. The maximum weight loss noted over the course of 52 weeks occurred in the placebo-to-apremilast group, with a mean 1.3-kg reduction.

“I would call the LIBERATE results a validation of the earlier data showing a very clean safety profile with this drug,” Dr. Reich said.

This is reflected in the product labeling, which unlike other systemic therapies for psoriasis includes no requirements for laboratory monitoring or tuberculosis testing.

Both the LIBERATE and the ESTEEM trials were sponsored by Celgene. Dr. Reich received research grants as an investigator in both programs.

[email protected]

COPENHAGEN – What can physicians and their psoriasis patients realistically expect from long-term apremilast therapy?

“I think the take-home number is a 50%-plus PASI-75 response after 1 year among patients with moderate to severe plaque psoriasis,” Dr. Kristian Reich said at the annual congress of the European Academy of Dermatology and Venereology.

He presented what he considers to be the first solid data addressing this key question. The data come from a new analysis of the 52-week results of the LIBERATE trial.

“Due to the randomized withdrawal design and long-term treatment only of responders in the original pivotal phase III ESTEEM program, I think we’ve had no real understanding from clinical trials of what the long-term efficacy of apremilast [Otezla] is. Of course, with psoriasis being a chronic disease, this is really what we want to know. And we can get this data very nicely from the LIBERATE study. I should point out that although LIBERATE is a relatively small study, every single patient is included here. So I think this is a very robust analysis of 1-year efficacy data,” said Dr. Reich, managing partner of Dermatologikum Hamburg (Germany).

In contrast to the inclusive analysis performed in LIBERATE, in the pivotal ESTEEM I trial a mere 77 of 562 psoriasis patients randomized to apremilast were on the oral phosphodiesterase type 4 inhibitor for the full 52-week study period, with 61% of that superselect subgroup showing a PASI-75 response (J Am Acad Dermatol. 2015 Jul;73[1]:37-49).

LIBERATE included 250 psoriasis patients. Their baseline Psoriasis Area and Severity Index (PASI) score was about 20, with 27% body surface area involved, a body mass index of 29 kg/m², 89 kg of body weight, and a mean Dermatology Life Quality Index (DLQI) score of 13. Seventy percent to 80% of subjects had previously used conventional systemic therapies, but no one was allowed to have prior use of biologic therapies.

Patients were randomized to one of three study arms: 16 weeks of oral apremilast at the approved dose of 30 mg twice daily plus a weekly placebo injection, subcutaneous etanercept (Enbrel) at 50 mg once weekly plus a placebo tablet, or dual placebos. At 16 weeks, all patients were switched to apremilast at 30 mg twice daily with no placebos through week 52.

The PASI-75 response rate at week 16 was 11.9% in the placebo group, 39.8% with apremilast, and 48.2% with etanercept.

“I am surprised to see in the more recent studies the high response to etanercept. This is fantastic data. Etanercept seems to ripen like old wine. It’s getting better the longer we have it,” the dermatologist commented.

The PASI-75 rates at 1 year were 46.4% with placebo/apremilast, 50.6% with apremilast throughout, and 55.4% with etanercept/apremilast.

The mean improvement in DLQI from baseline to 52 weeks – a secondary endpoint – was 6.6 points with placebo/apremilast, 8.0 with apremilast/apremilast, and 8.9 points with etanercept/apremilast. A noteworthy finding was that during the first 16 weeks apremilast brought a clinically meaningful improvement in quality of life significantly faster than etanercept did, with a significant difference seen between the two study arms even in the first 1-2 weeks.

The likely explanation for this benefit is that the mean reduction in pruritus visual analog scale scores was significantly greater with apremilast than etanercept through the first 8 weeks. Although pruritus is traditionally thought of more in the context of atopic dermatitis, it’s actually also the No. 1 complaint among psoriasis patients, according to Dr. Reich.

“This is a special thing with apremilast, that the pruritus really goes down very significantly early on. It raises an interesting question about what the role of phosphodiesterase-4 inhibition might be in pruritus. I couldn’t give you a molecular explanation, but I think because pruritus is so annoying and it definitely affects quality of life, this could be a possible explanation for why there is more rapid improvement in quality of life independent of the PASI improvement,” he said.

Switching from etanercept to apremilast didn’t result in any clinically significant safety findings through week 52. No meaningful laboratory changes occurred during 52 weeks of monitoring. There were no cases of suicidal ideation, no increase in serious infections, and only a single cardiac event. The most common apremilast-associated side effects seen in LIBERATE were loose stools in 8%-15% of patients, nausea in 10%, and headache in 13%. These adverse events were mild to moderate in nature and decreased in prevalence over time. The maximum weight loss noted over the course of 52 weeks occurred in the placebo-to-apremilast group, with a mean 1.3-kg reduction.

“I would call the LIBERATE results a validation of the earlier data showing a very clean safety profile with this drug,” Dr. Reich said.

This is reflected in the product labeling, which unlike other systemic therapies for psoriasis includes no requirements for laboratory monitoring or tuberculosis testing.

Both the LIBERATE and the ESTEEM trials were sponsored by Celgene. Dr. Reich received research grants as an investigator in both programs.

[email protected]

COPENHAGEN – Ixekizumab not only shows considerable promise for the treatment of moderate to severe psoriasis, it looks like it may be a winner for comorbid psoriatic arthritis, too.

The investigational IgG4 humanized monoclonal antibody directed against interleukin-17A brought marked improvements in joint pain, systemic inflammatory burden, and quality of life as well as skin disease in patients with both psoriasis and self-reported psoriatic arthritis in a combined analysis of three phase III clinical trials, Dr. Alice B. Gottlieb reported at the annual congress of the European Academy of Dermatology and Venereology.

Of the 3,126 patients with moderate to severe psoriasis who participated in the 12-week, phase III UNCOVER-1, -2, and -3 trials, 751 (24%) also had self-reported psoriatic arthritis; her analysis focused on them.

She was quick to note that the UNCOVER trials were primarily psoriasis studies that relied upon patient self-report of psoriatic arthritis. Nevertheless, it seems likely that the great majority of self-reported psoriatic arthritis patients really did have the rheumatologic disease, since the mean baseline C-reactive protein (CRP) level in that group was 8.43 mg/L, a level far higher than expected in patients with psoriasis only.

In any case, more-rigorous phase III studies of ixekizumab conducted specifically in patients with formally rheumatologist-diagnosed psoriatic arthritis and treated in rheumatology practices are due to be presented at the annual meeting of the American College of Rheumatology in November. And while Dr. Gottlieb wasn’t at liberty to discuss those results, she did hint that the data will be strongly positive.

“If you’re happy about these UNCOVER findings, you’ll be ecstatic about those,” predicted Dr. Gottlieb, professor of dermatology and dermatologist in chief at Tufts Medical Center, Boston.

Also coming up at the American College of Rheumatology meeting will be the results of the first-ever head-to-head comparison of an IL-17 inhibitor versus a tumor necrosis factor–alpha blocker in psoriatic arthritis patients. While at present most physicians consider a TNF inhibitor to be the treatment of choice in patients with psoriatic arthritis, that view may change as a result of the forthcoming comparative study, according to the dermatologist.

In each of the three phase III UNCOVER studies, patients were randomized to 12 weeks of subcutaneous ixekizumab at 80 mg every 2 or 4 weeks following a 160-mg loading dose, or to placebo. At baseline, the subgroup with self-reported psoriatic arthritis had a mean Psoriasis Area and Severity Index ( PASI) 0f about 21, a self-rated joint pain severity of 50 on a 0-100 scale, a CRP of 8.43 mg/L, and a Dermatology Life Quality Index (DLQI) score of 14.

Joint pain decreased dramatically in the two ixekizumab groups as early at 2 weeks into the trial, at which point, patients on treatment every 2 weeks averaged a 13.1-point reduction from baseline, with a similar 14.1-point drop noted in those on an every 4 weeks schedule. At week 12, the mean reductions from baseline were 25.2 and 26.8 points, compared with a 1.1-point increase in joint pain among placebo-treated controls.

Inflammatory burden plunged quickly, as evidenced by mean reductions in CRP of 4.63 mg/L and 4.33 mg/L at week 1 with biweekly and monthly dosing, respectively. These reductions were then maintained through week 12.

In terms of improvement in skin symptoms, with ixekizumab dosed every 2 weeks, the PASI 75 response was 89.8% at 12 weeks, the PASI 90 response was 69.3%, and the PASI 100 response (clear skin) was 37.1%. In patients treated every 4 weeks, the rates were 81.1%, 60.8%, and 34.7%.

“There’s good news in both groups, but I think the news is even better in the every-2-weeks group,” Dr. Gottlieb commented.

The mean 12-week decrease from baseline in DLQI was 11.8 points with biweekly dosing and 10.5 with 4-week dosing, compared with 0.8 points in controls. That’s impressive given that a 5-point reduction in DLQI is deemed clinically meaningful, the dermatologist observed. At 12 weeks, 56.5% of patients on ixekizumab every 2 weeks had a DLQI of 0 or 1, as did 54% on monthly dosing and 1.5% of controls.

The ixekizumab-treated groups also showed what Dr. Gottlieb described as “dramatic” improvements – in the 4+ to 5+ point range – in both the mental and physical component scores on the SF-36, another widely used quality of life measure.

Improvements in skin and self-reported joint symptoms appeared to correlate. Patients with a PASI 50 to less-than PASI 75 response had a mean 17-point reduction in joint pain scores, while those with a PASI 75 to less-than PASI 90 response averaged a 25.1-point improvement in joint pain, patients with a PASI 90 to less-than PASI 100 skin response averaged a 27.6-point reduction, and PASI 100 responders had a mean 30.3-point reduction in joint pain scores.

“Obviously, one needs to look at this more carefully in a phase III psoriatic arthritis study. That’ll provide a more robust answer. But this gives a hint,” the dermatologist said.

The UNCOVER program was sponsored by Eli Lilly. Dr. Gottlieb serves as an adviser to Lilly and numerous other pharmaceutical companies.

[email protected]

COPENHAGEN – Ixekizumab not only shows considerable promise for the treatment of moderate to severe psoriasis, it looks like it may be a winner for comorbid psoriatic arthritis, too.

The investigational IgG4 humanized monoclonal antibody directed against interleukin-17A brought marked improvements in joint pain, systemic inflammatory burden, and quality of life as well as skin disease in patients with both psoriasis and self-reported psoriatic arthritis in a combined analysis of three phase III clinical trials, Dr. Alice B. Gottlieb reported at the annual congress of the European Academy of Dermatology and Venereology.

Of the 3,126 patients with moderate to severe psoriasis who participated in the 12-week, phase III UNCOVER-1, -2, and -3 trials, 751 (24%) also had self-reported psoriatic arthritis; her analysis focused on them.

She was quick to note that the UNCOVER trials were primarily psoriasis studies that relied upon patient self-report of psoriatic arthritis. Nevertheless, it seems likely that the great majority of self-reported psoriatic arthritis patients really did have the rheumatologic disease, since the mean baseline C-reactive protein (CRP) level in that group was 8.43 mg/L, a level far higher than expected in patients with psoriasis only.

In any case, more-rigorous phase III studies of ixekizumab conducted specifically in patients with formally rheumatologist-diagnosed psoriatic arthritis and treated in rheumatology practices are due to be presented at the annual meeting of the American College of Rheumatology in November. And while Dr. Gottlieb wasn’t at liberty to discuss those results, she did hint that the data will be strongly positive.

“If you’re happy about these UNCOVER findings, you’ll be ecstatic about those,” predicted Dr. Gottlieb, professor of dermatology and dermatologist in chief at Tufts Medical Center, Boston.

Also coming up at the American College of Rheumatology meeting will be the results of the first-ever head-to-head comparison of an IL-17 inhibitor versus a tumor necrosis factor–alpha blocker in psoriatic arthritis patients. While at present most physicians consider a TNF inhibitor to be the treatment of choice in patients with psoriatic arthritis, that view may change as a result of the forthcoming comparative study, according to the dermatologist.

In each of the three phase III UNCOVER studies, patients were randomized to 12 weeks of subcutaneous ixekizumab at 80 mg every 2 or 4 weeks following a 160-mg loading dose, or to placebo. At baseline, the subgroup with self-reported psoriatic arthritis had a mean Psoriasis Area and Severity Index ( PASI) 0f about 21, a self-rated joint pain severity of 50 on a 0-100 scale, a CRP of 8.43 mg/L, and a Dermatology Life Quality Index (DLQI) score of 14.

Joint pain decreased dramatically in the two ixekizumab groups as early at 2 weeks into the trial, at which point, patients on treatment every 2 weeks averaged a 13.1-point reduction from baseline, with a similar 14.1-point drop noted in those on an every 4 weeks schedule. At week 12, the mean reductions from baseline were 25.2 and 26.8 points, compared with a 1.1-point increase in joint pain among placebo-treated controls.

Inflammatory burden plunged quickly, as evidenced by mean reductions in CRP of 4.63 mg/L and 4.33 mg/L at week 1 with biweekly and monthly dosing, respectively. These reductions were then maintained through week 12.

In terms of improvement in skin symptoms, with ixekizumab dosed every 2 weeks, the PASI 75 response was 89.8% at 12 weeks, the PASI 90 response was 69.3%, and the PASI 100 response (clear skin) was 37.1%. In patients treated every 4 weeks, the rates were 81.1%, 60.8%, and 34.7%.

“There’s good news in both groups, but I think the news is even better in the every-2-weeks group,” Dr. Gottlieb commented.

The mean 12-week decrease from baseline in DLQI was 11.8 points with biweekly dosing and 10.5 with 4-week dosing, compared with 0.8 points in controls. That’s impressive given that a 5-point reduction in DLQI is deemed clinically meaningful, the dermatologist observed. At 12 weeks, 56.5% of patients on ixekizumab every 2 weeks had a DLQI of 0 or 1, as did 54% on monthly dosing and 1.5% of controls.

The ixekizumab-treated groups also showed what Dr. Gottlieb described as “dramatic” improvements – in the 4+ to 5+ point range – in both the mental and physical component scores on the SF-36, another widely used quality of life measure.

Improvements in skin and self-reported joint symptoms appeared to correlate. Patients with a PASI 50 to less-than PASI 75 response had a mean 17-point reduction in joint pain scores, while those with a PASI 75 to less-than PASI 90 response averaged a 25.1-point improvement in joint pain, patients with a PASI 90 to less-than PASI 100 skin response averaged a 27.6-point reduction, and PASI 100 responders had a mean 30.3-point reduction in joint pain scores.

“Obviously, one needs to look at this more carefully in a phase III psoriatic arthritis study. That’ll provide a more robust answer. But this gives a hint,” the dermatologist said.

The UNCOVER program was sponsored by Eli Lilly. Dr. Gottlieb serves as an adviser to Lilly and numerous other pharmaceutical companies.

[email protected]

COPENHAGEN – Ixekizumab not only shows considerable promise for the treatment of moderate to severe psoriasis, it looks like it may be a winner for comorbid psoriatic arthritis, too.

The investigational IgG4 humanized monoclonal antibody directed against interleukin-17A brought marked improvements in joint pain, systemic inflammatory burden, and quality of life as well as skin disease in patients with both psoriasis and self-reported psoriatic arthritis in a combined analysis of three phase III clinical trials, Dr. Alice B. Gottlieb reported at the annual congress of the European Academy of Dermatology and Venereology.

Of the 3,126 patients with moderate to severe psoriasis who participated in the 12-week, phase III UNCOVER-1, -2, and -3 trials, 751 (24%) also had self-reported psoriatic arthritis; her analysis focused on them.

She was quick to note that the UNCOVER trials were primarily psoriasis studies that relied upon patient self-report of psoriatic arthritis. Nevertheless, it seems likely that the great majority of self-reported psoriatic arthritis patients really did have the rheumatologic disease, since the mean baseline C-reactive protein (CRP) level in that group was 8.43 mg/L, a level far higher than expected in patients with psoriasis only.

In any case, more-rigorous phase III studies of ixekizumab conducted specifically in patients with formally rheumatologist-diagnosed psoriatic arthritis and treated in rheumatology practices are due to be presented at the annual meeting of the American College of Rheumatology in November. And while Dr. Gottlieb wasn’t at liberty to discuss those results, she did hint that the data will be strongly positive.

“If you’re happy about these UNCOVER findings, you’ll be ecstatic about those,” predicted Dr. Gottlieb, professor of dermatology and dermatologist in chief at Tufts Medical Center, Boston.

Also coming up at the American College of Rheumatology meeting will be the results of the first-ever head-to-head comparison of an IL-17 inhibitor versus a tumor necrosis factor–alpha blocker in psoriatic arthritis patients. While at present most physicians consider a TNF inhibitor to be the treatment of choice in patients with psoriatic arthritis, that view may change as a result of the forthcoming comparative study, according to the dermatologist.

In each of the three phase III UNCOVER studies, patients were randomized to 12 weeks of subcutaneous ixekizumab at 80 mg every 2 or 4 weeks following a 160-mg loading dose, or to placebo. At baseline, the subgroup with self-reported psoriatic arthritis had a mean Psoriasis Area and Severity Index ( PASI) 0f about 21, a self-rated joint pain severity of 50 on a 0-100 scale, a CRP of 8.43 mg/L, and a Dermatology Life Quality Index (DLQI) score of 14.

Joint pain decreased dramatically in the two ixekizumab groups as early at 2 weeks into the trial, at which point, patients on treatment every 2 weeks averaged a 13.1-point reduction from baseline, with a similar 14.1-point drop noted in those on an every 4 weeks schedule. At week 12, the mean reductions from baseline were 25.2 and 26.8 points, compared with a 1.1-point increase in joint pain among placebo-treated controls.

Inflammatory burden plunged quickly, as evidenced by mean reductions in CRP of 4.63 mg/L and 4.33 mg/L at week 1 with biweekly and monthly dosing, respectively. These reductions were then maintained through week 12.

In terms of improvement in skin symptoms, with ixekizumab dosed every 2 weeks, the PASI 75 response was 89.8% at 12 weeks, the PASI 90 response was 69.3%, and the PASI 100 response (clear skin) was 37.1%. In patients treated every 4 weeks, the rates were 81.1%, 60.8%, and 34.7%.

“There’s good news in both groups, but I think the news is even better in the every-2-weeks group,” Dr. Gottlieb commented.

The mean 12-week decrease from baseline in DLQI was 11.8 points with biweekly dosing and 10.5 with 4-week dosing, compared with 0.8 points in controls. That’s impressive given that a 5-point reduction in DLQI is deemed clinically meaningful, the dermatologist observed. At 12 weeks, 56.5% of patients on ixekizumab every 2 weeks had a DLQI of 0 or 1, as did 54% on monthly dosing and 1.5% of controls.

The ixekizumab-treated groups also showed what Dr. Gottlieb described as “dramatic” improvements – in the 4+ to 5+ point range – in both the mental and physical component scores on the SF-36, another widely used quality of life measure.

Improvements in skin and self-reported joint symptoms appeared to correlate. Patients with a PASI 50 to less-than PASI 75 response had a mean 17-point reduction in joint pain scores, while those with a PASI 75 to less-than PASI 90 response averaged a 25.1-point improvement in joint pain, patients with a PASI 90 to less-than PASI 100 skin response averaged a 27.6-point reduction, and PASI 100 responders had a mean 30.3-point reduction in joint pain scores.

“Obviously, one needs to look at this more carefully in a phase III psoriatic arthritis study. That’ll provide a more robust answer. But this gives a hint,” the dermatologist said.

The UNCOVER program was sponsored by Eli Lilly. Dr. Gottlieb serves as an adviser to Lilly and numerous other pharmaceutical companies.

[email protected]

COPENHAGEN – An investigational biologic agent that selectively inhibits the p19 subunit of interleukin-23 was the talk of the 2015 EADV congress based upon its striking outperformance of ustekinumab in a head-to-head phase II study in psoriasis patients.

Not only did the investigational agent, known for now as BI 655066, achieve substantially higher rates of PASI 90 – clear or almost clear skin – and PASI 100, but it did so much faster and maintained those stellar results far longer off treatment than with ustekinumab (Stelara), Dr. Kim A. Papp reported at the annual congress of the European Academy of Dermatology and Venereology.

“These data make an irrefutable case for IL-23 as instrumental in the expression of psoriasis,” declared Dr. Papp, president of Probity Medical Research in Waterloo, Ont.

“What these data show is that selective blockade of IL-23 p19 clearly provides a remarkable response, whether we measure it as PASI 75, PASI 90, or PASI 100, compared with ustekinumab, which provides a very robust response itself. And when we look at the safety profile – admittedly in a small number of patients and for a short period of time – we see there are no real differences in safety signals. Obviously, we’re very encouraged to move forward with long-term phase III investigations,” Dr. Papp added.

The multicenter, double-blind phase II study included 166 patients with moderate to severe plaque psoriasis who were randomized to one of four treatment arms: BI 655066 at 90 or 180 mg given subcutaneously at weeks 0, 4, and 16; weight-based ustekinumab at 45 or 90 mg given on the same schedule; or a single 18-mg dose of BI 655066. Dr. Papp presented the results at 36 weeks, fully 20 weeks after the final dose was given.

Significantly more patients taking the investigational agent achieved PASI targets than did those taking ustekinumab, a highly effective medication. Here are the eye-popping 36-week results:

• PASI 90: 81% with BI 655066 at 180 mg, 69% with the lower dose, 30% with ustekinumab, and 7% with a single 18-mg dose of BI 655066.

• PASI 100: 54% and 43% with high- and low-dose BI 655066, respectively, 15% with ustekinumab, and 0% with single-dose BI 655066.

• PASI 75: 93% and 88% with high- and low-dose BI 655066; 55% with ustekinumab; and 19% after single-dose BI 655066.

One of the most intriguing study findings, according to Dr. Papp, is that the slope of the PASI 100 response curve in BI 655066–treated patients was still rising at week 20, a month after the final dose.

“It suggests that if you were to continue treating these patients, you might anticipate an even higher response,” the dermatologist said.

Another notable finding was the accelerated speed of response to the investigational agent: 57 days after the first dose of BI 655066, 50% of patients had a PASI 90 response.

“That means from the time you initiate therapy, you can expect half of your patients to get to PASI 90 in less than 2 months time,” Dr. Papp observed.

In contrast, it took 117 days – basically twice as long – for half of the ustekinumab group to achieve PASI 90.

Turning to the durability of response, Dr. Papp noted that it took 169 days for half of patients in the ustekinumab group to lose their PASI 90 response after treatment stopped, compared with 225 days in the BI 655066 90-mg group. That endpoint was never reached in the BI 655066 180-mg group before the study’s end.

Audience reaction to the study results was “wow.”

“Obviously, the data are terrific. Your mother couldn’t have invented better data,” declared Dr. Alice B. Gottlieb, professor of dermatology and dermatologist in chief at Tufts Medical Center, Boston.

She posed a question: Why are the BI 655066 response rates so much higher and longer lasting than with other biologics, including ustekinumab, which inhibits both IL-23 and IL-12?

“I think one key factor in the durability of the response is the pathway,” Dr. Papp replied. “Exactly why blockade of IL-23 p19 leads to this durable clinical response is unclear, but we can posit that we’re depopulating the Th-17 cells. IL-23 is necessary for Th-17 cell survival. So if you block the water, you ain’t going to grow the grass. I’m speculating here, but I think we’re removing that clone of cells, and it’s only once we start to allow them to repopulate that we then see recurrence of the disease.”

BI 655066 is being developed by Boehringer Ingelheim. Dr. Papp serves as an investigator for and consultant to Boehringer Ingelheim and numerous other pharmaceutical companies.

[email protected]

COPENHAGEN – An investigational biologic agent that selectively inhibits the p19 subunit of interleukin-23 was the talk of the 2015 EADV congress based upon its striking outperformance of ustekinumab in a head-to-head phase II study in psoriasis patients.

Not only did the investigational agent, known for now as BI 655066, achieve substantially higher rates of PASI 90 – clear or almost clear skin – and PASI 100, but it did so much faster and maintained those stellar results far longer off treatment than with ustekinumab (Stelara), Dr. Kim A. Papp reported at the annual congress of the European Academy of Dermatology and Venereology.

“These data make an irrefutable case for IL-23 as instrumental in the expression of psoriasis,” declared Dr. Papp, president of Probity Medical Research in Waterloo, Ont.

“What these data show is that selective blockade of IL-23 p19 clearly provides a remarkable response, whether we measure it as PASI 75, PASI 90, or PASI 100, compared with ustekinumab, which provides a very robust response itself. And when we look at the safety profile – admittedly in a small number of patients and for a short period of time – we see there are no real differences in safety signals. Obviously, we’re very encouraged to move forward with long-term phase III investigations,” Dr. Papp added.

The multicenter, double-blind phase II study included 166 patients with moderate to severe plaque psoriasis who were randomized to one of four treatment arms: BI 655066 at 90 or 180 mg given subcutaneously at weeks 0, 4, and 16; weight-based ustekinumab at 45 or 90 mg given on the same schedule; or a single 18-mg dose of BI 655066. Dr. Papp presented the results at 36 weeks, fully 20 weeks after the final dose was given.

Significantly more patients taking the investigational agent achieved PASI targets than did those taking ustekinumab, a highly effective medication. Here are the eye-popping 36-week results:

• PASI 90: 81% with BI 655066 at 180 mg, 69% with the lower dose, 30% with ustekinumab, and 7% with a single 18-mg dose of BI 655066.

• PASI 100: 54% and 43% with high- and low-dose BI 655066, respectively, 15% with ustekinumab, and 0% with single-dose BI 655066.

• PASI 75: 93% and 88% with high- and low-dose BI 655066; 55% with ustekinumab; and 19% after single-dose BI 655066.

One of the most intriguing study findings, according to Dr. Papp, is that the slope of the PASI 100 response curve in BI 655066–treated patients was still rising at week 20, a month after the final dose.

“It suggests that if you were to continue treating these patients, you might anticipate an even higher response,” the dermatologist said.

Another notable finding was the accelerated speed of response to the investigational agent: 57 days after the first dose of BI 655066, 50% of patients had a PASI 90 response.

“That means from the time you initiate therapy, you can expect half of your patients to get to PASI 90 in less than 2 months time,” Dr. Papp observed.

In contrast, it took 117 days – basically twice as long – for half of the ustekinumab group to achieve PASI 90.

Turning to the durability of response, Dr. Papp noted that it took 169 days for half of patients in the ustekinumab group to lose their PASI 90 response after treatment stopped, compared with 225 days in the BI 655066 90-mg group. That endpoint was never reached in the BI 655066 180-mg group before the study’s end.

Audience reaction to the study results was “wow.”

“Obviously, the data are terrific. Your mother couldn’t have invented better data,” declared Dr. Alice B. Gottlieb, professor of dermatology and dermatologist in chief at Tufts Medical Center, Boston.

She posed a question: Why are the BI 655066 response rates so much higher and longer lasting than with other biologics, including ustekinumab, which inhibits both IL-23 and IL-12?

“I think one key factor in the durability of the response is the pathway,” Dr. Papp replied. “Exactly why blockade of IL-23 p19 leads to this durable clinical response is unclear, but we can posit that we’re depopulating the Th-17 cells. IL-23 is necessary for Th-17 cell survival. So if you block the water, you ain’t going to grow the grass. I’m speculating here, but I think we’re removing that clone of cells, and it’s only once we start to allow them to repopulate that we then see recurrence of the disease.”

BI 655066 is being developed by Boehringer Ingelheim. Dr. Papp serves as an investigator for and consultant to Boehringer Ingelheim and numerous other pharmaceutical companies.

[email protected]

COPENHAGEN – An investigational biologic agent that selectively inhibits the p19 subunit of interleukin-23 was the talk of the 2015 EADV congress based upon its striking outperformance of ustekinumab in a head-to-head phase II study in psoriasis patients.

Not only did the investigational agent, known for now as BI 655066, achieve substantially higher rates of PASI 90 – clear or almost clear skin – and PASI 100, but it did so much faster and maintained those stellar results far longer off treatment than with ustekinumab (Stelara), Dr. Kim A. Papp reported at the annual congress of the European Academy of Dermatology and Venereology.

“These data make an irrefutable case for IL-23 as instrumental in the expression of psoriasis,” declared Dr. Papp, president of Probity Medical Research in Waterloo, Ont.

“What these data show is that selective blockade of IL-23 p19 clearly provides a remarkable response, whether we measure it as PASI 75, PASI 90, or PASI 100, compared with ustekinumab, which provides a very robust response itself. And when we look at the safety profile – admittedly in a small number of patients and for a short period of time – we see there are no real differences in safety signals. Obviously, we’re very encouraged to move forward with long-term phase III investigations,” Dr. Papp added.

The multicenter, double-blind phase II study included 166 patients with moderate to severe plaque psoriasis who were randomized to one of four treatment arms: BI 655066 at 90 or 180 mg given subcutaneously at weeks 0, 4, and 16; weight-based ustekinumab at 45 or 90 mg given on the same schedule; or a single 18-mg dose of BI 655066. Dr. Papp presented the results at 36 weeks, fully 20 weeks after the final dose was given.

Significantly more patients taking the investigational agent achieved PASI targets than did those taking ustekinumab, a highly effective medication. Here are the eye-popping 36-week results:

• PASI 90: 81% with BI 655066 at 180 mg, 69% with the lower dose, 30% with ustekinumab, and 7% with a single 18-mg dose of BI 655066.

• PASI 100: 54% and 43% with high- and low-dose BI 655066, respectively, 15% with ustekinumab, and 0% with single-dose BI 655066.

• PASI 75: 93% and 88% with high- and low-dose BI 655066; 55% with ustekinumab; and 19% after single-dose BI 655066.

One of the most intriguing study findings, according to Dr. Papp, is that the slope of the PASI 100 response curve in BI 655066–treated patients was still rising at week 20, a month after the final dose.

“It suggests that if you were to continue treating these patients, you might anticipate an even higher response,” the dermatologist said.

Another notable finding was the accelerated speed of response to the investigational agent: 57 days after the first dose of BI 655066, 50% of patients had a PASI 90 response.

“That means from the time you initiate therapy, you can expect half of your patients to get to PASI 90 in less than 2 months time,” Dr. Papp observed.

In contrast, it took 117 days – basically twice as long – for half of the ustekinumab group to achieve PASI 90.

Turning to the durability of response, Dr. Papp noted that it took 169 days for half of patients in the ustekinumab group to lose their PASI 90 response after treatment stopped, compared with 225 days in the BI 655066 90-mg group. That endpoint was never reached in the BI 655066 180-mg group before the study’s end.

Audience reaction to the study results was “wow.”

“Obviously, the data are terrific. Your mother couldn’t have invented better data,” declared Dr. Alice B. Gottlieb, professor of dermatology and dermatologist in chief at Tufts Medical Center, Boston.

She posed a question: Why are the BI 655066 response rates so much higher and longer lasting than with other biologics, including ustekinumab, which inhibits both IL-23 and IL-12?

“I think one key factor in the durability of the response is the pathway,” Dr. Papp replied. “Exactly why blockade of IL-23 p19 leads to this durable clinical response is unclear, but we can posit that we’re depopulating the Th-17 cells. IL-23 is necessary for Th-17 cell survival. So if you block the water, you ain’t going to grow the grass. I’m speculating here, but I think we’re removing that clone of cells, and it’s only once we start to allow them to repopulate that we then see recurrence of the disease.”

BI 655066 is being developed by Boehringer Ingelheim. Dr. Papp serves as an investigator for and consultant to Boehringer Ingelheim and numerous other pharmaceutical companies.

[email protected]

A combination of calcipotriene and betamethasone dipropionate in a foam formulation has been approved by the Food and Drug Administration for the topical treatment of plaque psoriasis in adults, according to the manufacturer.

The product will be marketed as Enstilar (calcipotriene and betamethasone dipropionate) foam, 0.005%/0.064%, by Leo Pharma.

Each gram contains 52.2 mcg calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone); it is applied to affected areas once a day for up to 4 weeks, according to the prescribing information, which states that patient should not use more than 60 g every 4 days.

The vitamin D analog-corticosteroid combination product was compared with treatment with the two individual components and/or a vehicle only, in more than 700 patients with plaque psoriasis in two studies. At baseline, about two-thirds of the patients had moderate disease, 14%-15% had mild disease, and 10% had moderately severe disease, based on a 5-point Investigator’s Global Assessment scale. The proportion of patients who were considered clear or almost clear at 4 weeks, based on IGA scale results, was the efficacy endpoint defining treatment success. Among patients with mild disease at baseline, treatment was considered successful if they were considered clear at 4 weeks.

In one study of 302 patients, 45% treated with the combination product had achieved treatment success at week 4 vs. 30.7% of those treated with betamethasone and 14.9% treated with calcipotriene, according to the prescribing information. In the second study, 323 patients were treated with the combination product and 103 received the vehicle. At 4 weeks, 53.3% of those treated with the foam met the efficacy endpoint vs. 4.8% of those in the vehicle group.

Application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and psoriasis exacerbations were among the adverse reactions reported in fewer than 1% of those treated with the combination product. The warnings and precautions section of the prescribing information includes a statement noting that the product contains propellants that are flammable, and that patients should be advised to “avoid fire, flame, or smoking during and immediately after using this product.”

This approval is for an adult population. As a postmarketing commitment, the FDA is requiring that the company conduct a study in pediatric patients with plaque psoriasis, according to the agency’s approval letter, dated Oct. 16. That study is described as an open-label study to assess the effect of the product on calcium metabolism in pediatric patients aged 12-16 years, with plaque psoriasis of the scalp and body. In a subgroup of these children, pharmacokinetics and hypothalamic-pituitary axis suppression also will be assessed, the letter says.

Serious adverse events associated with this product should be reported to the FDA’s MedWatch program at 800-332-1088, or http://www.fda.gov/Safety/MedWatch/default.htm.

[email protected]

A combination of calcipotriene and betamethasone dipropionate in a foam formulation has been approved by the Food and Drug Administration for the topical treatment of plaque psoriasis in adults, according to the manufacturer.

The product will be marketed as Enstilar (calcipotriene and betamethasone dipropionate) foam, 0.005%/0.064%, by Leo Pharma.

Each gram contains 52.2 mcg calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone); it is applied to affected areas once a day for up to 4 weeks, according to the prescribing information, which states that patient should not use more than 60 g every 4 days.

The vitamin D analog-corticosteroid combination product was compared with treatment with the two individual components and/or a vehicle only, in more than 700 patients with plaque psoriasis in two studies. At baseline, about two-thirds of the patients had moderate disease, 14%-15% had mild disease, and 10% had moderately severe disease, based on a 5-point Investigator’s Global Assessment scale. The proportion of patients who were considered clear or almost clear at 4 weeks, based on IGA scale results, was the efficacy endpoint defining treatment success. Among patients with mild disease at baseline, treatment was considered successful if they were considered clear at 4 weeks.

In one study of 302 patients, 45% treated with the combination product had achieved treatment success at week 4 vs. 30.7% of those treated with betamethasone and 14.9% treated with calcipotriene, according to the prescribing information. In the second study, 323 patients were treated with the combination product and 103 received the vehicle. At 4 weeks, 53.3% of those treated with the foam met the efficacy endpoint vs. 4.8% of those in the vehicle group.

Application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and psoriasis exacerbations were among the adverse reactions reported in fewer than 1% of those treated with the combination product. The warnings and precautions section of the prescribing information includes a statement noting that the product contains propellants that are flammable, and that patients should be advised to “avoid fire, flame, or smoking during and immediately after using this product.”

This approval is for an adult population. As a postmarketing commitment, the FDA is requiring that the company conduct a study in pediatric patients with plaque psoriasis, according to the agency’s approval letter, dated Oct. 16. That study is described as an open-label study to assess the effect of the product on calcium metabolism in pediatric patients aged 12-16 years, with plaque psoriasis of the scalp and body. In a subgroup of these children, pharmacokinetics and hypothalamic-pituitary axis suppression also will be assessed, the letter says.

Serious adverse events associated with this product should be reported to the FDA’s MedWatch program at 800-332-1088, or http://www.fda.gov/Safety/MedWatch/default.htm.

[email protected]

A combination of calcipotriene and betamethasone dipropionate in a foam formulation has been approved by the Food and Drug Administration for the topical treatment of plaque psoriasis in adults, according to the manufacturer.

The product will be marketed as Enstilar (calcipotriene and betamethasone dipropionate) foam, 0.005%/0.064%, by Leo Pharma.

Each gram contains 52.2 mcg calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone); it is applied to affected areas once a day for up to 4 weeks, according to the prescribing information, which states that patient should not use more than 60 g every 4 days.

The vitamin D analog-corticosteroid combination product was compared with treatment with the two individual components and/or a vehicle only, in more than 700 patients with plaque psoriasis in two studies. At baseline, about two-thirds of the patients had moderate disease, 14%-15% had mild disease, and 10% had moderately severe disease, based on a 5-point Investigator’s Global Assessment scale. The proportion of patients who were considered clear or almost clear at 4 weeks, based on IGA scale results, was the efficacy endpoint defining treatment success. Among patients with mild disease at baseline, treatment was considered successful if they were considered clear at 4 weeks.

In one study of 302 patients, 45% treated with the combination product had achieved treatment success at week 4 vs. 30.7% of those treated with betamethasone and 14.9% treated with calcipotriene, according to the prescribing information. In the second study, 323 patients were treated with the combination product and 103 received the vehicle. At 4 weeks, 53.3% of those treated with the foam met the efficacy endpoint vs. 4.8% of those in the vehicle group.

Application site irritation, application site pruritus, folliculitis, skin hypopigmentation, hypercalcemia, urticaria, and psoriasis exacerbations were among the adverse reactions reported in fewer than 1% of those treated with the combination product. The warnings and precautions section of the prescribing information includes a statement noting that the product contains propellants that are flammable, and that patients should be advised to “avoid fire, flame, or smoking during and immediately after using this product.”

This approval is for an adult population. As a postmarketing commitment, the FDA is requiring that the company conduct a study in pediatric patients with plaque psoriasis, according to the agency’s approval letter, dated Oct. 16. That study is described as an open-label study to assess the effect of the product on calcium metabolism in pediatric patients aged 12-16 years, with plaque psoriasis of the scalp and body. In a subgroup of these children, pharmacokinetics and hypothalamic-pituitary axis suppression also will be assessed, the letter says.

Serious adverse events associated with this product should be reported to the FDA’s MedWatch program at 800-332-1088, or http://www.fda.gov/Safety/MedWatch/default.htm.

[email protected]

Baseline radiographic damage and the presence of dactylitis at 5 years are independent predictors of further joint destruction in people with psoriatic arthritis, according to follow-up data from a psoriatic arthritis registry.

The analysis of hand and foot radiographic findings from 72 patients (29 men, 43 women) participating in the Swedish Early Psoriatic Arthritis Registry (SwePsA) registry found that radiographic progression in early PsA was generally slow but was substantial in men. At entry to the registry, the patients had a mean age of about 48 years and had symptoms for a median of 12 months. Most had polyarticular disease as a result of the registry’s protocol, and none had arthritis mutilans or axial disease only. Three men and none of the women had combined axial and peripheral disease, reported Dr. Mats Geijer of the Center for Medical Imaging and Physiology at Skåne University Hospital, Lund, Sweden, and his colleagues (J Rheumatol. 2015 Oct 15. doi: 10.3899/jrheum.150165).

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Only 4 (14%) of the men did not have radiographic changes at 5 years, compared with 17 (40%) women, making male sex a risk factor for structural abnormality (odds ratio, 4.09; 95% confidence interval, 1.2-13.8; P = .024). Most of the radiographic changes in men occurred in the feet. Baseline radiographic changes also were a significant predictor of additional radiographic damage at 5 years (OR, 3.4; 95% CI, 2.2-5.2; P less than .001).

In a multivariate linear regression analysis, only baseline radiographic score and the presence of dactylitis at 5 years were independent predictors of a high radiographic score at 5-year follow-up.

The findings suggested that men improve clinically but develop radiographic changes, whereas women show less clinical improvement but do not develop joint damage to the same extent as men. This gender-divergent behavior could be taken into consideration when planning treatment and care for patients, the authors said.

For example, women may require more interventions against functional deterioration and help coping with pain and men may need follow-up radiography, especially in the presence of dactylitis, high disease activity, and a known propensity for radiographic destruction, they suggested.

“Radiography and scoring the hands and feet at baseline are important and cannot be substituted with clinical signs, especially in men,” they concluded.

The study was supported by independent grants from the Swedish Psoriasis Foundation, Skåne University Hospital (SUS Fonder) and Pfizer.

Baseline radiographic damage and the presence of dactylitis at 5 years are independent predictors of further joint destruction in people with psoriatic arthritis, according to follow-up data from a psoriatic arthritis registry.

The analysis of hand and foot radiographic findings from 72 patients (29 men, 43 women) participating in the Swedish Early Psoriatic Arthritis Registry (SwePsA) registry found that radiographic progression in early PsA was generally slow but was substantial in men. At entry to the registry, the patients had a mean age of about 48 years and had symptoms for a median of 12 months. Most had polyarticular disease as a result of the registry’s protocol, and none had arthritis mutilans or axial disease only. Three men and none of the women had combined axial and peripheral disease, reported Dr. Mats Geijer of the Center for Medical Imaging and Physiology at Skåne University Hospital, Lund, Sweden, and his colleagues (J Rheumatol. 2015 Oct 15. doi: 10.3899/jrheum.150165).

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Only 4 (14%) of the men did not have radiographic changes at 5 years, compared with 17 (40%) women, making male sex a risk factor for structural abnormality (odds ratio, 4.09; 95% confidence interval, 1.2-13.8; P = .024). Most of the radiographic changes in men occurred in the feet. Baseline radiographic changes also were a significant predictor of additional radiographic damage at 5 years (OR, 3.4; 95% CI, 2.2-5.2; P less than .001).

In a multivariate linear regression analysis, only baseline radiographic score and the presence of dactylitis at 5 years were independent predictors of a high radiographic score at 5-year follow-up.

The findings suggested that men improve clinically but develop radiographic changes, whereas women show less clinical improvement but do not develop joint damage to the same extent as men. This gender-divergent behavior could be taken into consideration when planning treatment and care for patients, the authors said.

For example, women may require more interventions against functional deterioration and help coping with pain and men may need follow-up radiography, especially in the presence of dactylitis, high disease activity, and a known propensity for radiographic destruction, they suggested.

“Radiography and scoring the hands and feet at baseline are important and cannot be substituted with clinical signs, especially in men,” they concluded.

The study was supported by independent grants from the Swedish Psoriasis Foundation, Skåne University Hospital (SUS Fonder) and Pfizer.

Baseline radiographic damage and the presence of dactylitis at 5 years are independent predictors of further joint destruction in people with psoriatic arthritis, according to follow-up data from a psoriatic arthritis registry.

The analysis of hand and foot radiographic findings from 72 patients (29 men, 43 women) participating in the Swedish Early Psoriatic Arthritis Registry (SwePsA) registry found that radiographic progression in early PsA was generally slow but was substantial in men. At entry to the registry, the patients had a mean age of about 48 years and had symptoms for a median of 12 months. Most had polyarticular disease as a result of the registry’s protocol, and none had arthritis mutilans or axial disease only. Three men and none of the women had combined axial and peripheral disease, reported Dr. Mats Geijer of the Center for Medical Imaging and Physiology at Skåne University Hospital, Lund, Sweden, and his colleagues (J Rheumatol. 2015 Oct 15. doi: 10.3899/jrheum.150165).

Courtesy Wikimedia Commons/James Heilman/Creative Commons License

Only 4 (14%) of the men did not have radiographic changes at 5 years, compared with 17 (40%) women, making male sex a risk factor for structural abnormality (odds ratio, 4.09; 95% confidence interval, 1.2-13.8; P = .024). Most of the radiographic changes in men occurred in the feet. Baseline radiographic changes also were a significant predictor of additional radiographic damage at 5 years (OR, 3.4; 95% CI, 2.2-5.2; P less than .001).

In a multivariate linear regression analysis, only baseline radiographic score and the presence of dactylitis at 5 years were independent predictors of a high radiographic score at 5-year follow-up.

The findings suggested that men improve clinically but develop radiographic changes, whereas women show less clinical improvement but do not develop joint damage to the same extent as men. This gender-divergent behavior could be taken into consideration when planning treatment and care for patients, the authors said.

For example, women may require more interventions against functional deterioration and help coping with pain and men may need follow-up radiography, especially in the presence of dactylitis, high disease activity, and a known propensity for radiographic destruction, they suggested.

“Radiography and scoring the hands and feet at baseline are important and cannot be substituted with clinical signs, especially in men,” they concluded.

The study was supported by independent grants from the Swedish Psoriasis Foundation, Skåne University Hospital (SUS Fonder) and Pfizer.

COPENHAGEN – Severe psoriasis is an independent risk factor for serious renal disease – and psoriatic arthritis multiplies that risk even further, according to a Taiwanese national study.

“We think this might be related to the higher inflammatory status associated with psoriatic arthritis. For those with mild psoriasis without psoriatic arthritis, the risk was not increased,” Dr. Ching-Chi Chi said at the annual congress of the European Academy of Dermatology and Venereology.

The past decade has brought a mountain of data documenting that psoriasis, a chronic inflammatory dermatosis, is associated with increased risks of cardiovascular disease, diabetes, and other metabolic abnormalities, noted Dr. Chi, professor of dermatology at Chang Gung University in Taoyuan.

He presented a nationwide retrospective cohort study utilizing Taiwan’s national health insurance system, which covers more than 99% of the population. The study included 4,633 patients with psoriasis diagnosed by a dermatologist or rheumatologist since 2005 and 922,534 controls. A total of 453 patients were classified as having severe psoriasis based upon ever having received systemic treatment or phototherapy; the other 4,180 were classified as having mild psoriasis.

Among the controls there were 36,615 incident cases of chronic kidney disease (CKD) and 9,493 new cases of end-stage renal disease (ESRD) during the study period, translating to rates of 676 per 1,000,000 person-years and 172 per 1,000,000 person-years, respectively. In contrast, patients with severe psoriasis had an incident CKD rate of 2,160 per 1,000,000 person-years and an ESRD rate of 876 per 1,000,000 person-years.

In a Cox regression analysis adjusted for potential confounders including age, gender, comorbid cardiovascular disease, gout, hypertension, dyslipidemia, and use of NSAIDs, severe psoriasis was independently associated with a 1.9-fold increased risk of new-onset CKD and a 3-fold increased risk of ESRD.

Although mild psoriasis alone wasn’t associated with increased risk of renal disease, the 254 patients with mild psoriasis and psoriatic arthritis were at 1.3-fold increased risk of CKD and 2.5-fold increased risk of incident ESRD, compared with controls. Moreover, among the 93 patients with severe psoriasis plus psoriatic arthritis, the risks of incident CKD and ESRD were increased by 2.6- and 6.7-fold over the control subjects.

The new Taiwanese national study confirms earlier work by Dr. Joel M. Gelfand and his coinvestigators at the University of Pennsylvania, Philadelphia. Their population-based cohort study and nested cross-sectional study utilizing a huge U.K. electronic medical records database analyzed 136,529 patients with mild psoriasis, 7,354 with severe psoriasis, and nearly 690,000 matched controls and concluded that moderate to severe psoriasis is associated with an increased risk of stage 3-5 chronic kidney disease (BMJ. 2013 Oct 15;347:f5961).

He reported having no financial conflicts regarding this study.

[email protected]

This article was updated October 29, 2015.

COPENHAGEN – Severe psoriasis is an independent risk factor for serious renal disease – and psoriatic arthritis multiplies that risk even further, according to a Taiwanese national study.

“We think this might be related to the higher inflammatory status associated with psoriatic arthritis. For those with mild psoriasis without psoriatic arthritis, the risk was not increased,” Dr. Ching-Chi Chi said at the annual congress of the European Academy of Dermatology and Venereology.

The past decade has brought a mountain of data documenting that psoriasis, a chronic inflammatory dermatosis, is associated with increased risks of cardiovascular disease, diabetes, and other metabolic abnormalities, noted Dr. Chi, professor of dermatology at Chang Gung University in Taoyuan.

He presented a nationwide retrospective cohort study utilizing Taiwan’s national health insurance system, which covers more than 99% of the population. The study included 4,633 patients with psoriasis diagnosed by a dermatologist or rheumatologist since 2005 and 922,534 controls. A total of 453 patients were classified as having severe psoriasis based upon ever having received systemic treatment or phototherapy; the other 4,180 were classified as having mild psoriasis.

Among the controls there were 36,615 incident cases of chronic kidney disease (CKD) and 9,493 new cases of end-stage renal disease (ESRD) during the study period, translating to rates of 676 per 1,000,000 person-years and 172 per 1,000,000 person-years, respectively. In contrast, patients with severe psoriasis had an incident CKD rate of 2,160 per 1,000,000 person-years and an ESRD rate of 876 per 1,000,000 person-years.

In a Cox regression analysis adjusted for potential confounders including age, gender, comorbid cardiovascular disease, gout, hypertension, dyslipidemia, and use of NSAIDs, severe psoriasis was independently associated with a 1.9-fold increased risk of new-onset CKD and a 3-fold increased risk of ESRD.

Although mild psoriasis alone wasn’t associated with increased risk of renal disease, the 254 patients with mild psoriasis and psoriatic arthritis were at 1.3-fold increased risk of CKD and 2.5-fold increased risk of incident ESRD, compared with controls. Moreover, among the 93 patients with severe psoriasis plus psoriatic arthritis, the risks of incident CKD and ESRD were increased by 2.6- and 6.7-fold over the control subjects.

The new Taiwanese national study confirms earlier work by Dr. Joel M. Gelfand and his coinvestigators at the University of Pennsylvania, Philadelphia. Their population-based cohort study and nested cross-sectional study utilizing a huge U.K. electronic medical records database analyzed 136,529 patients with mild psoriasis, 7,354 with severe psoriasis, and nearly 690,000 matched controls and concluded that moderate to severe psoriasis is associated with an increased risk of stage 3-5 chronic kidney disease (BMJ. 2013 Oct 15;347:f5961).

He reported having no financial conflicts regarding this study.

[email protected]

This article was updated October 29, 2015.

COPENHAGEN – Severe psoriasis is an independent risk factor for serious renal disease – and psoriatic arthritis multiplies that risk even further, according to a Taiwanese national study.

“We think this might be related to the higher inflammatory status associated with psoriatic arthritis. For those with mild psoriasis without psoriatic arthritis, the risk was not increased,” Dr. Ching-Chi Chi said at the annual congress of the European Academy of Dermatology and Venereology.

The past decade has brought a mountain of data documenting that psoriasis, a chronic inflammatory dermatosis, is associated with increased risks of cardiovascular disease, diabetes, and other metabolic abnormalities, noted Dr. Chi, professor of dermatology at Chang Gung University in Taoyuan.

He presented a nationwide retrospective cohort study utilizing Taiwan’s national health insurance system, which covers more than 99% of the population. The study included 4,633 patients with psoriasis diagnosed by a dermatologist or rheumatologist since 2005 and 922,534 controls. A total of 453 patients were classified as having severe psoriasis based upon ever having received systemic treatment or phototherapy; the other 4,180 were classified as having mild psoriasis.

Among the controls there were 36,615 incident cases of chronic kidney disease (CKD) and 9,493 new cases of end-stage renal disease (ESRD) during the study period, translating to rates of 676 per 1,000,000 person-years and 172 per 1,000,000 person-years, respectively. In contrast, patients with severe psoriasis had an incident CKD rate of 2,160 per 1,000,000 person-years and an ESRD rate of 876 per 1,000,000 person-years.

In a Cox regression analysis adjusted for potential confounders including age, gender, comorbid cardiovascular disease, gout, hypertension, dyslipidemia, and use of NSAIDs, severe psoriasis was independently associated with a 1.9-fold increased risk of new-onset CKD and a 3-fold increased risk of ESRD.

Although mild psoriasis alone wasn’t associated with increased risk of renal disease, the 254 patients with mild psoriasis and psoriatic arthritis were at 1.3-fold increased risk of CKD and 2.5-fold increased risk of incident ESRD, compared with controls. Moreover, among the 93 patients with severe psoriasis plus psoriatic arthritis, the risks of incident CKD and ESRD were increased by 2.6- and 6.7-fold over the control subjects.

The new Taiwanese national study confirms earlier work by Dr. Joel M. Gelfand and his coinvestigators at the University of Pennsylvania, Philadelphia. Their population-based cohort study and nested cross-sectional study utilizing a huge U.K. electronic medical records database analyzed 136,529 patients with mild psoriasis, 7,354 with severe psoriasis, and nearly 690,000 matched controls and concluded that moderate to severe psoriasis is associated with an increased risk of stage 3-5 chronic kidney disease (BMJ. 2013 Oct 15;347:f5961).

He reported having no financial conflicts regarding this study.

[email protected]

This article was updated October 29, 2015.

COPENHAGEN – Long-term weight loss achieved by obese patients with psoriasis provides long-lasting reductions in psoriasis severity, Dr. Peter Jensen reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a prospective 64-week observational study that was a follow-up to his earlier 16-week randomized, controlled clinical trial. The earlier study (JAMA Dermatol. 2013 Jul;149[7]:795-801) generated enormous interest because it provided the first level I evidence that weight loss by obese psoriasis patients brings clinically meaningful improvement in their skin disease as well as achieving well-established metabolic and cardiovascular risk reduction benefits.

Bruce Jancin/Frontline Medical News

In the randomized trial, 60 consecutive obese patients with psoriasis and a mean baseline Psoriasis Area and Severity Index (PASI) of 5.4 and a body mass index of 34.4 kg/m² were assigned to a dietary intervention or given general advice to eat healthy foods. The intervention entailed 8 weeks of a low-energy liquid diet featuring a daily total nutrition intake of 800-1,000 kcal in the form of fortified drinks and soups. This was followed by 8 weeks in which regular foods were reintroduced at 1,200 kcal/day. At week 16, the intervention group had lost an average of 15.4 kg more body weight than controls. Their mean PASI was 2.0 points lower as well, according to Dr. Jensen, a dermatologist at the University of Copenhagen.

In the observational follow-up study, the original control group was offered the opportunity to participate in the 16-week weight loss intervention. All patients were then prospectively followed for 48 weeks after completing the dietary intervention. Psoriasis medications weren’t changed during the study period. The questions Dr. Jensen and coinvestigators sought to answer through the follow-up study were, first, can patients keep the weight off long term without a structured maintenance program and, if so, do their PASI scores stay low or do they creep back up?

Only 32 of the original 60 patients completed the full 64-week study. Among the completers, as is typical in weight loss studies, there was a gradual weight regain. Nonetheless, at 64 weeks, patients still maintained a mean 10-kg weight loss, compared with baseline, or two-thirds of the weight loss achieved during the 16-week dietary intervention.

Most importantly from a dermatologic perspective, the positive effect upon disease severity was maintained despite the regain of one-third of the initial weight loss, with patients showing a clinically important mean 3-point reduction in PASI, compared with baseline, Dr. Jensen noted.

Audience members were enthusiastic about the study findings but asked if the results are widely applicable. In other words, was this an unusually highly motivated group of patients?

“Our experience is that people really would like to try this. It was no problem to get participation,” according to Dr. Jensen.

Study limitations included the small sample size and the fact that this was a patient cohort with relatively mild psoriasis. In the future, it would be informative to study the effects of weight loss in obese patients with higher baseline PASI scores, the dermatologist said.

The study was funded by the Danish Academy of Dermatology and various research foundations. Dr. Jensen reported having no financial conflicts.

[email protected]

COPENHAGEN – Long-term weight loss achieved by obese patients with psoriasis provides long-lasting reductions in psoriasis severity, Dr. Peter Jensen reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a prospective 64-week observational study that was a follow-up to his earlier 16-week randomized, controlled clinical trial. The earlier study (JAMA Dermatol. 2013 Jul;149[7]:795-801) generated enormous interest because it provided the first level I evidence that weight loss by obese psoriasis patients brings clinically meaningful improvement in their skin disease as well as achieving well-established metabolic and cardiovascular risk reduction benefits.

Bruce Jancin/Frontline Medical News

In the randomized trial, 60 consecutive obese patients with psoriasis and a mean baseline Psoriasis Area and Severity Index (PASI) of 5.4 and a body mass index of 34.4 kg/m² were assigned to a dietary intervention or given general advice to eat healthy foods. The intervention entailed 8 weeks of a low-energy liquid diet featuring a daily total nutrition intake of 800-1,000 kcal in the form of fortified drinks and soups. This was followed by 8 weeks in which regular foods were reintroduced at 1,200 kcal/day. At week 16, the intervention group had lost an average of 15.4 kg more body weight than controls. Their mean PASI was 2.0 points lower as well, according to Dr. Jensen, a dermatologist at the University of Copenhagen.

In the observational follow-up study, the original control group was offered the opportunity to participate in the 16-week weight loss intervention. All patients were then prospectively followed for 48 weeks after completing the dietary intervention. Psoriasis medications weren’t changed during the study period. The questions Dr. Jensen and coinvestigators sought to answer through the follow-up study were, first, can patients keep the weight off long term without a structured maintenance program and, if so, do their PASI scores stay low or do they creep back up?

Only 32 of the original 60 patients completed the full 64-week study. Among the completers, as is typical in weight loss studies, there was a gradual weight regain. Nonetheless, at 64 weeks, patients still maintained a mean 10-kg weight loss, compared with baseline, or two-thirds of the weight loss achieved during the 16-week dietary intervention.

Most importantly from a dermatologic perspective, the positive effect upon disease severity was maintained despite the regain of one-third of the initial weight loss, with patients showing a clinically important mean 3-point reduction in PASI, compared with baseline, Dr. Jensen noted.

Audience members were enthusiastic about the study findings but asked if the results are widely applicable. In other words, was this an unusually highly motivated group of patients?

“Our experience is that people really would like to try this. It was no problem to get participation,” according to Dr. Jensen.

Study limitations included the small sample size and the fact that this was a patient cohort with relatively mild psoriasis. In the future, it would be informative to study the effects of weight loss in obese patients with higher baseline PASI scores, the dermatologist said.

The study was funded by the Danish Academy of Dermatology and various research foundations. Dr. Jensen reported having no financial conflicts.

[email protected]

COPENHAGEN – Long-term weight loss achieved by obese patients with psoriasis provides long-lasting reductions in psoriasis severity, Dr. Peter Jensen reported at the annual congress of the European Academy of Dermatology and Venereology.

He presented a prospective 64-week observational study that was a follow-up to his earlier 16-week randomized, controlled clinical trial. The earlier study (JAMA Dermatol. 2013 Jul;149[7]:795-801) generated enormous interest because it provided the first level I evidence that weight loss by obese psoriasis patients brings clinically meaningful improvement in their skin disease as well as achieving well-established metabolic and cardiovascular risk reduction benefits.

Bruce Jancin/Frontline Medical News

In the randomized trial, 60 consecutive obese patients with psoriasis and a mean baseline Psoriasis Area and Severity Index (PASI) of 5.4 and a body mass index of 34.4 kg/m² were assigned to a dietary intervention or given general advice to eat healthy foods. The intervention entailed 8 weeks of a low-energy liquid diet featuring a daily total nutrition intake of 800-1,000 kcal in the form of fortified drinks and soups. This was followed by 8 weeks in which regular foods were reintroduced at 1,200 kcal/day. At week 16, the intervention group had lost an average of 15.4 kg more body weight than controls. Their mean PASI was 2.0 points lower as well, according to Dr. Jensen, a dermatologist at the University of Copenhagen.

In the observational follow-up study, the original control group was offered the opportunity to participate in the 16-week weight loss intervention. All patients were then prospectively followed for 48 weeks after completing the dietary intervention. Psoriasis medications weren’t changed during the study period. The questions Dr. Jensen and coinvestigators sought to answer through the follow-up study were, first, can patients keep the weight off long term without a structured maintenance program and, if so, do their PASI scores stay low or do they creep back up?

Only 32 of the original 60 patients completed the full 64-week study. Among the completers, as is typical in weight loss studies, there was a gradual weight regain. Nonetheless, at 64 weeks, patients still maintained a mean 10-kg weight loss, compared with baseline, or two-thirds of the weight loss achieved during the 16-week dietary intervention.

Most importantly from a dermatologic perspective, the positive effect upon disease severity was maintained despite the regain of one-third of the initial weight loss, with patients showing a clinically important mean 3-point reduction in PASI, compared with baseline, Dr. Jensen noted.

Audience members were enthusiastic about the study findings but asked if the results are widely applicable. In other words, was this an unusually highly motivated group of patients?

“Our experience is that people really would like to try this. It was no problem to get participation,” according to Dr. Jensen.

Study limitations included the small sample size and the fact that this was a patient cohort with relatively mild psoriasis. In the future, it would be informative to study the effects of weight loss in obese patients with higher baseline PASI scores, the dermatologist said.

The study was funded by the Danish Academy of Dermatology and various research foundations. Dr. Jensen reported having no financial conflicts.

[email protected]

At the Rheumatic Skin Disease Clinic in Manhasset, N.Y., dermatologist Dr. Amit Garg regularly discusses patient cases and develops care plans alongside rheumatologists after each specialist separately visits the same patient. The dual dermatology-rheumatology clinic has led to countless benefits, including improved quality of care for patients and multi-discipline training for new and veteran physicians, said Dr. Garg, clinic codirector and chair of the dermatology department at North Shore–Long Island Jewish Health System in New York.

Perhaps the greatest advantage of the combined clinic, however, is the research inspiration generated by the collaboration. “Working closely with colleagues in another discipline makes the environment really ripe for new ideas based on observations we may see in the patients we’re treating,” Dr. Garg said in an interview. “It’s amazing how when you’re thinking through a patient’s care together, how quickly you appreciate where the gaps are in our understanding of disease and evaluation and management of disease. From there, you take it to the next step of planning research projects or protocols to essentially fill those gaps in knowledge.”

Dr. Garg’s clinic is one of a growing number at U.S. academic medical centers that combine dermatologic and rheumatologic care for the management of psoriatic arthritis (PsA) and other interrelated skin and musculoskeletal diseases. Clinic operations vary from virtual consults, to simultaneous assessments, to sequential patient visits, but all focus on collaborative care and disease management. The institutions using such models recently united to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network, a national organization that develops research initiatives and assists other centers in creating similar programs. At least 10 institutions are now participating in the network, including NYU Langone Medical Center, New York; Harvard University’s Brigham and Women’s Hospital, Boston; and the National Psoriasis Foundation, Portland, Ore.

Combining dermatology and rheumatology care through a dual clinic follows an ongoing trend by academic medical centers to integrate specialties that treat overlapping conditions, said Dr. Alexis R. Ogdie-Beatty, a rheumatologist at the University of Pennsylvania Health System in Philadelphia and director of the Penn Psoriatic Arthritis Program.

“It was kind of a natural thing for rheumatic disease because our diseases are multisystem in nature in most cases,” Dr. Ogdie-Beatty said in an interview. “I think the increasing knowledge of the need for communication [between specialists] drove this.”

Dr. Ogdie-Beatty leads a virtual rheumatology-dermatology clinic at the University of Pennsylvania where she meets weekly with two dermatologists to discuss research studies, shared patients, and case management. The physicians primarily see patients separately, but occasionally will visit patients at the same time, she said. In addition, dermatologists on the team immediately contact Dr. Ogdie-Beatty if they are seeing a patient who might benefit from an assessment by the rheumatologist and vice versa, she said.

“One of our favorite parts is learning from each other,” Dr. Ogdie-Beatty said in an interview. “I’ve learned a lot about skin disease and psoriasis, and they’ve learned about inflammatory arthritis and management. The ultimate impact for the patient is to have more well rounded care so that both the skin disease and the arthritis are being taken care of in a comprehensive way.”

©Jay Omobono

Dermatology and rheumatology medical students and residents exposed to such clinics have the unique opportunity to learn about disease overlap and strengthen their understanding of the other’s specialty, added Dr. Joseph F. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. Dr. Merola’s center also has created a fellowship program in which either a dermatologist or rheumatologist can spend 1 year training at the clinic.

Research opportunities abound at the combined clinics, physicians said. At the Center for Skin and Related Musculoskeletal Diseases for example, physicians have developed new outcome metrics for measuring psoriasis and screening for PsA, Dr. Merola said. Physicians also commonly refer clinic patients for clinical trials, he said.

“It’s a great place for patients who have been through many other therapies,” said Dr. Merola, who practices dermatology and rheumatology. “If they are at the end of the line, we have a number of clinical trials that we can offer them. Because it tends to be a referral center, these are patients who have more complex disease, so being able to offer them clinical trials and multiple opinions has been really key.”

Dr. Ogdie-Beatty’s clinic is participating in a variety of research studies, including an analysis of vascular inflammation in psoriasis patients. The study is examining markers of early joint inflammation among psoriasis patients who don’t have symptoms of joint pain. Another initiative focuses on how to implement psoriasis and PsA disease activity measures into the medical record, Dr. Ogdie-Beatty said.

At a combined dermatology-rheumatology clinic within the University Health Network, Toronto, doctors are studying the incidence of arthritis and comorbidities in patients with psoriasis, said Dr. Vinod Chandran, a rheumatologist at the University of Toronto. Another ongoing study focuses on identifying risk factors for PsA in patients with psoriasis. The Toronto clinic is participating in the studies as part of the International Psoriasis and Arthritis Research Team.

“There are a number of research opportunities in the combined clinic since a detailed clinical evaluation is extremely important in biomarker and translational studies,” said Dr. Chandran, who codirects the psoriatic arthritis program at the Centre for Prognosis Studies in the Rheumatic Diseases, Toronto. “The clinic also provides an opportunity to participate in phase II and III clinical trials.”

Managing the combined derm-rheum clinics does come with challenges, doctors said. The obstacles are primarily logistical, and include identifying the space, time, and scheduling for the clinic, Dr. Garg said. Other challenges revolve around reimbursement, such as figuring out the best payment structure and ensuring that insurers will cover the simultaneous care, Dr. Merola said. Generally, it also takes longer to see the patient, and physicians may not be able to see as many patients together per day as they could alone, he added. However, physicians stress that the benefits of the combined clinics far outweigh the negatives.

“We’ve always felt the value has been there because we feel the patients really appreciate the service,” he said. “And we think the quality of care around what we do is better.”

[email protected]

On Twitter@legal_med

At the Rheumatic Skin Disease Clinic in Manhasset, N.Y., dermatologist Dr. Amit Garg regularly discusses patient cases and develops care plans alongside rheumatologists after each specialist separately visits the same patient. The dual dermatology-rheumatology clinic has led to countless benefits, including improved quality of care for patients and multi-discipline training for new and veteran physicians, said Dr. Garg, clinic codirector and chair of the dermatology department at North Shore–Long Island Jewish Health System in New York.

Perhaps the greatest advantage of the combined clinic, however, is the research inspiration generated by the collaboration. “Working closely with colleagues in another discipline makes the environment really ripe for new ideas based on observations we may see in the patients we’re treating,” Dr. Garg said in an interview. “It’s amazing how when you’re thinking through a patient’s care together, how quickly you appreciate where the gaps are in our understanding of disease and evaluation and management of disease. From there, you take it to the next step of planning research projects or protocols to essentially fill those gaps in knowledge.”

Dr. Garg’s clinic is one of a growing number at U.S. academic medical centers that combine dermatologic and rheumatologic care for the management of psoriatic arthritis (PsA) and other interrelated skin and musculoskeletal diseases. Clinic operations vary from virtual consults, to simultaneous assessments, to sequential patient visits, but all focus on collaborative care and disease management. The institutions using such models recently united to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network, a national organization that develops research initiatives and assists other centers in creating similar programs. At least 10 institutions are now participating in the network, including NYU Langone Medical Center, New York; Harvard University’s Brigham and Women’s Hospital, Boston; and the National Psoriasis Foundation, Portland, Ore.

Combining dermatology and rheumatology care through a dual clinic follows an ongoing trend by academic medical centers to integrate specialties that treat overlapping conditions, said Dr. Alexis R. Ogdie-Beatty, a rheumatologist at the University of Pennsylvania Health System in Philadelphia and director of the Penn Psoriatic Arthritis Program.

“It was kind of a natural thing for rheumatic disease because our diseases are multisystem in nature in most cases,” Dr. Ogdie-Beatty said in an interview. “I think the increasing knowledge of the need for communication [between specialists] drove this.”

Dr. Ogdie-Beatty leads a virtual rheumatology-dermatology clinic at the University of Pennsylvania where she meets weekly with two dermatologists to discuss research studies, shared patients, and case management. The physicians primarily see patients separately, but occasionally will visit patients at the same time, she said. In addition, dermatologists on the team immediately contact Dr. Ogdie-Beatty if they are seeing a patient who might benefit from an assessment by the rheumatologist and vice versa, she said.

“One of our favorite parts is learning from each other,” Dr. Ogdie-Beatty said in an interview. “I’ve learned a lot about skin disease and psoriasis, and they’ve learned about inflammatory arthritis and management. The ultimate impact for the patient is to have more well rounded care so that both the skin disease and the arthritis are being taken care of in a comprehensive way.”

©Jay Omobono

Dermatology and rheumatology medical students and residents exposed to such clinics have the unique opportunity to learn about disease overlap and strengthen their understanding of the other’s specialty, added Dr. Joseph F. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. Dr. Merola’s center also has created a fellowship program in which either a dermatologist or rheumatologist can spend 1 year training at the clinic.

Research opportunities abound at the combined clinics, physicians said. At the Center for Skin and Related Musculoskeletal Diseases for example, physicians have developed new outcome metrics for measuring psoriasis and screening for PsA, Dr. Merola said. Physicians also commonly refer clinic patients for clinical trials, he said.

“It’s a great place for patients who have been through many other therapies,” said Dr. Merola, who practices dermatology and rheumatology. “If they are at the end of the line, we have a number of clinical trials that we can offer them. Because it tends to be a referral center, these are patients who have more complex disease, so being able to offer them clinical trials and multiple opinions has been really key.”

Dr. Ogdie-Beatty’s clinic is participating in a variety of research studies, including an analysis of vascular inflammation in psoriasis patients. The study is examining markers of early joint inflammation among psoriasis patients who don’t have symptoms of joint pain. Another initiative focuses on how to implement psoriasis and PsA disease activity measures into the medical record, Dr. Ogdie-Beatty said.

At a combined dermatology-rheumatology clinic within the University Health Network, Toronto, doctors are studying the incidence of arthritis and comorbidities in patients with psoriasis, said Dr. Vinod Chandran, a rheumatologist at the University of Toronto. Another ongoing study focuses on identifying risk factors for PsA in patients with psoriasis. The Toronto clinic is participating in the studies as part of the International Psoriasis and Arthritis Research Team.

“There are a number of research opportunities in the combined clinic since a detailed clinical evaluation is extremely important in biomarker and translational studies,” said Dr. Chandran, who codirects the psoriatic arthritis program at the Centre for Prognosis Studies in the Rheumatic Diseases, Toronto. “The clinic also provides an opportunity to participate in phase II and III clinical trials.”

Managing the combined derm-rheum clinics does come with challenges, doctors said. The obstacles are primarily logistical, and include identifying the space, time, and scheduling for the clinic, Dr. Garg said. Other challenges revolve around reimbursement, such as figuring out the best payment structure and ensuring that insurers will cover the simultaneous care, Dr. Merola said. Generally, it also takes longer to see the patient, and physicians may not be able to see as many patients together per day as they could alone, he added. However, physicians stress that the benefits of the combined clinics far outweigh the negatives.

“We’ve always felt the value has been there because we feel the patients really appreciate the service,” he said. “And we think the quality of care around what we do is better.”

[email protected]

On Twitter@legal_med

At the Rheumatic Skin Disease Clinic in Manhasset, N.Y., dermatologist Dr. Amit Garg regularly discusses patient cases and develops care plans alongside rheumatologists after each specialist separately visits the same patient. The dual dermatology-rheumatology clinic has led to countless benefits, including improved quality of care for patients and multi-discipline training for new and veteran physicians, said Dr. Garg, clinic codirector and chair of the dermatology department at North Shore–Long Island Jewish Health System in New York.

Perhaps the greatest advantage of the combined clinic, however, is the research inspiration generated by the collaboration. “Working closely with colleagues in another discipline makes the environment really ripe for new ideas based on observations we may see in the patients we’re treating,” Dr. Garg said in an interview. “It’s amazing how when you’re thinking through a patient’s care together, how quickly you appreciate where the gaps are in our understanding of disease and evaluation and management of disease. From there, you take it to the next step of planning research projects or protocols to essentially fill those gaps in knowledge.”

Dr. Garg’s clinic is one of a growing number at U.S. academic medical centers that combine dermatologic and rheumatologic care for the management of psoriatic arthritis (PsA) and other interrelated skin and musculoskeletal diseases. Clinic operations vary from virtual consults, to simultaneous assessments, to sequential patient visits, but all focus on collaborative care and disease management. The institutions using such models recently united to form the Psoriasis and Psoriatic Arthritis Clinics Multicenter Advancement Network, a national organization that develops research initiatives and assists other centers in creating similar programs. At least 10 institutions are now participating in the network, including NYU Langone Medical Center, New York; Harvard University’s Brigham and Women’s Hospital, Boston; and the National Psoriasis Foundation, Portland, Ore.

Combining dermatology and rheumatology care through a dual clinic follows an ongoing trend by academic medical centers to integrate specialties that treat overlapping conditions, said Dr. Alexis R. Ogdie-Beatty, a rheumatologist at the University of Pennsylvania Health System in Philadelphia and director of the Penn Psoriatic Arthritis Program.

“It was kind of a natural thing for rheumatic disease because our diseases are multisystem in nature in most cases,” Dr. Ogdie-Beatty said in an interview. “I think the increasing knowledge of the need for communication [between specialists] drove this.”

Dr. Ogdie-Beatty leads a virtual rheumatology-dermatology clinic at the University of Pennsylvania where she meets weekly with two dermatologists to discuss research studies, shared patients, and case management. The physicians primarily see patients separately, but occasionally will visit patients at the same time, she said. In addition, dermatologists on the team immediately contact Dr. Ogdie-Beatty if they are seeing a patient who might benefit from an assessment by the rheumatologist and vice versa, she said.

“One of our favorite parts is learning from each other,” Dr. Ogdie-Beatty said in an interview. “I’ve learned a lot about skin disease and psoriasis, and they’ve learned about inflammatory arthritis and management. The ultimate impact for the patient is to have more well rounded care so that both the skin disease and the arthritis are being taken care of in a comprehensive way.”

©Jay Omobono

Dermatology and rheumatology medical students and residents exposed to such clinics have the unique opportunity to learn about disease overlap and strengthen their understanding of the other’s specialty, added Dr. Joseph F. Merola, codirector of the Center for Skin and Related Musculoskeletal Diseases, a combined clinic at Brigham and Women’s Hospital in Boston. Dr. Merola’s center also has created a fellowship program in which either a dermatologist or rheumatologist can spend 1 year training at the clinic.

Research opportunities abound at the combined clinics, physicians said. At the Center for Skin and Related Musculoskeletal Diseases for example, physicians have developed new outcome metrics for measuring psoriasis and screening for PsA, Dr. Merola said. Physicians also commonly refer clinic patients for clinical trials, he said.

“It’s a great place for patients who have been through many other therapies,” said Dr. Merola, who practices dermatology and rheumatology. “If they are at the end of the line, we have a number of clinical trials that we can offer them. Because it tends to be a referral center, these are patients who have more complex disease, so being able to offer them clinical trials and multiple opinions has been really key.”

Dr. Ogdie-Beatty’s clinic is participating in a variety of research studies, including an analysis of vascular inflammation in psoriasis patients. The study is examining markers of early joint inflammation among psoriasis patients who don’t have symptoms of joint pain. Another initiative focuses on how to implement psoriasis and PsA disease activity measures into the medical record, Dr. Ogdie-Beatty said.

At a combined dermatology-rheumatology clinic within the University Health Network, Toronto, doctors are studying the incidence of arthritis and comorbidities in patients with psoriasis, said Dr. Vinod Chandran, a rheumatologist at the University of Toronto. Another ongoing study focuses on identifying risk factors for PsA in patients with psoriasis. The Toronto clinic is participating in the studies as part of the International Psoriasis and Arthritis Research Team.

“There are a number of research opportunities in the combined clinic since a detailed clinical evaluation is extremely important in biomarker and translational studies,” said Dr. Chandran, who codirects the psoriatic arthritis program at the Centre for Prognosis Studies in the Rheumatic Diseases, Toronto. “The clinic also provides an opportunity to participate in phase II and III clinical trials.”

Managing the combined derm-rheum clinics does come with challenges, doctors said. The obstacles are primarily logistical, and include identifying the space, time, and scheduling for the clinic, Dr. Garg said. Other challenges revolve around reimbursement, such as figuring out the best payment structure and ensuring that insurers will cover the simultaneous care, Dr. Merola said. Generally, it also takes longer to see the patient, and physicians may not be able to see as many patients together per day as they could alone, he added. However, physicians stress that the benefits of the combined clinics far outweigh the negatives.

“We’ve always felt the value has been there because we feel the patients really appreciate the service,” he said. “And we think the quality of care around what we do is better.”

[email protected]

On Twitter@legal_med