DERM on RheumNow Podcast (March 2026) Save
This month: Multiple FDA regulatory decisions germane to dermatology, psoriasis and lupus; and Eosinophilic Fasciitis (EF) reminder and should you worry about fibromyalgia?
Show Notes:
1. FDA Approves Icotrokinra for Plaque Psoriasis The FDA approved an oral IL-23 inhibitor, icotrokinra (Icotyde), for use in moderate-to-severe plaque psoriasis in adults and children 12 years of age and older who are candidates for systemic therapy or phototherapy, according to a https://t.co/q5b3TceFHx
2. FDA has approved secukinumab (Cosentyx) for use pediatric patients (aged 12yrs) with moderate to severe hidradenitis suppurativa https://t.co/oX4LGU16QP
3. FDA has accepted the supplemental biologics license application for use of interleukin-23 inhibitor tildrakizumab (Ilumya; Sun Pharma) in active psoriatic arthritis (PsA) in adults. https://t.co/cwqz9DoWsL https://t.co/ut0A4MwqW7
4. TYK2 Inhibitor Deucravacitinib FDA Approved for Psoriatic Arthritis On Friday, March 6th, the FDA approved deucravacitinib (Sotyktu) for the treatment of adults with active PsA based on the results of the pivotal Phase 3 POETYK PsA-1 and POETYK PsA-2 clinical trials. https://t.co/a6rmortnoS
5.vUCB announced topline results of the BE-BOLD head-to-head study where bimekizumab (IL-17i) was superior to risankizumab (IL-23i) study; 553 active PsA in achieving an ACR50 response at 16 weeks. Enrolled PsA pts were either bilogic naïve or who had previous exposure to 1 TNFi
6. Retrospective TriNetX Network cohort study of adult PsA (N 123,031) pts, propensity- matched to non-PsA controls. PsA had signif higher CV morbidity: MACE (HR 1.74); mortality (HR 1.95); CHF (HR 1.96), MI (HR 1.71), & CVA (HR 1.49). bDMARDs reduced MACE (HR 0.95) & mortality (HR 0.92) vs csDMARDs https://t.co/bHrq9KpwBM
7. Prevalence of fibromyalgia in PsA = 18%. FM-PsA pts have higher scores Dz activity scores from FM, rather than inflammation. Fibromyalgia is assoc w/ worse disease outcomes, including failure to achieve low disease activity state and poorer response to therapy. https://t.co/utQRXPmpDs
8. JAMA Patient Education Page on JAMA Eosinophilic Fasciitis (EF). EF is rare, but begins with swelling and redness of the arms and/or legs. Later the skin thickens and develops the peau d' orange appearance. EF does not involve fingers or toes, & doesnt have Raynauds https://t.co/WEFFITtmQC
9. REVEAL, a 5-yr real-world study of 236 SLE pts initiating anifrolumab (basekbube SLEDAI-2K 7 for mucocutaneous (67%) & MSK (49%) dz. At 6 months, 26% achieved remission, 66% reached LLDAS, and 57% achieved LLDAS5. Authors claim rapid onset of action https://t.co/16OQatOcPj https://t.co/mU9aciCNcH
10. Update on FDA complete response letter to AZ regarding BLA hold for anifrolumab (Saphnelo) for SC use in SLE. CRL originally issued 10/10/25, but announced 2/3/26. FDA CRL cites critical data quality w/ key analyses in SC-TULIP study. A BLA decision expected in 1st half of 2026 https://t.co/zuwtsdL6I9
11. NEJM: Obinutuzumab in Active Systemic Lupus Erythematosus https://rheumnow.com/news/nejm-obinutuzumab-active-systemic-lupus-eryth…
Transcription
Welcome to the Derm on RheumNow podcast for March 2026. I'm doctor Jack Cush, executive editor of roomnow.com. This podcast is a monthly podcast dedicated to dermatologists and skin focused health care professionals where we discuss the intersection between rheumatology and dermatology. To do this, we curate the news and research and regulatory advances on men number disorders relevant to you, including psoriasis, psoriatic arthritis, lupus, vasculitis, hidradenitis, other connective tissue disease. We also discover and discuss the many drug similarities we have, biologics, biologics, Jack's, and other therapeutics that are really central to dermatology.
The focus is practical use, real world efficacy, knowing the side effects, knowing the advances. We hope that you can follow this news on roomnow.com. You can go there, sign up for either the daily email that we send to everyone, which has sort of five news items every day, or a weekly email, or even a topic email. This week on the podcast, many FDA regulatory decisions on psoriatic disease and lupus. A reminder about eosinophilic fasciitis, and also should you worry about fibromyalgia.
At the top of the list is the FDA approval of an oral IL-twenty three inhibitor, icotrokinra icotrokinra for plaque psoriasis. It was approved just recently this month for use in moderate to severe plaque psoriasis in adults, but also in children aged 12 and over who are at least forty kilograms in weight. To be eligible you need to be a candidate for systemic therapy or phototherapy. There's a new package insert that you can consult, and basically it tells you the drug looks pretty safe. It starts working at four weeks, it seems to have maximal responses by sixteen weeks as far as posse 90 responses.
The starting dose and usual daily dose is two hundred milligrams orally given every day and given thirty minutes before food. Looks like you need an empty stomach to get full absorption. Approval is based on four ICONIC trials, they're called the ICONIC trials, that these phase three trials showed efficacy and safety in over two thousand five hundred adults and adolescents with either active plaque psoriasis, but also there were sub studies on scalp psoriasis and genital psoriasis, and there were also two studies against other drugs, that you use, including ducravacitinib and ustekinumab. The trials basically showed that nearly seventy percent of people have, almost complete clearing of their skin, and at least fifty five percent achieve a PASI 90 by week sixteen. Major advance for you, we're waiting to see what it's going to do in psoriatic arthritis where there are trials going on right now.
FDA also active in pediatric disease by approving secukinumab for kids over the age of 12 with moderate to severe hidradenitis suppurativa. As you know, secukinumab is already approved for adults with hidradenitis. The FDA has also accepted the supplemental BLA biologics application for tildrakizumab, the IL-twenty three inhibitor for use in psoriatic arthritis. Of course it's approved already for use in psoriasis as an IL-twenty three inhibitor. A supplemental BLA biologic license application, means they want to amend their indication list and add this to the list based on the data and they're developing that data.
Also approved this month was ducravacitinib, the TYK2 inhibitor, for use in psoriatic arthritis. Currently available in psoriasis, now it's available for psoriatic arthritis. This happened on March 6. The indication is adults with active PSA based on the results of two phase three POETK PSA1, PSA2 trials showing efficacy and safety. I think this is a nice addition.
TYK2 inhibitors will sort of round out the oral options for patients with psoriatic arthritis. The other big news, at least for us rheumatologists, was UCB announcing in a press release the top line results of their B BOLD study. UCB makes bimekizumab the dual IL-seventeen inhibitor of IL-17A and F. This was a head to head trial of bimekizumab against the IL-twenty three inhibitor, rizenkizumab, five fifty three patients showing with a primary endpoint of an ACR 50, which is a pretty good response, sort of like your PASI 90, at week sixteen they had favorable results against of the bimekizumab IL-seventeen against IL-twenty three. The patients had to be either biologic naive at entry or they could have been exposed to one, but a max of one TNF inhibitor.
We don't have the details and data, but we don't have head to head trials like you do in dermatology. You guys, I think, are smarter and more aggressive in seeing who the top dog is, what's your go to drug when your first option may not work as well. Rheumatology, we have very few, you can count them on one hand, number of head to head trials, and certainly very few in psoriatic disease. This sort of is a retrospective network analysis using the Trinetix. I don't know if you're familiar with the Trinetix network.
This is a linkage of many EMRs, and they do studies that involve hundreds of thousands of patients. And they do propensity matching, and maybe they give us data that you can't get otherwise. But this is sort of simulated data, not real data. It's not a real clinical trial, it's not even a real registry. They're just finding out what's out there, and then trying to correct for it with propensity matching.
Well, anyway, in this study of one hundred and twenty three thousand adult psoriatic arthritis patients who were matched against non PSA controls, also twenty three one hundred and twenty three thousand, they showed what you already know: that psoriatic disease is associated with a significantly higher cardiovascular morbidity and mortality. MACE events are seventy four percent higher mortality is a doubling of events. Heart failure almost a doubling of events. MI seventy one percent higher. CVA forty nine percent higher.
And this was all in psoriatic arthritis patients, not psoriasis, where maybe the inflammation burden might be even higher. The other thing that was important about this analysis was that when they compared patients treated with biologic DMARDs versus conventional oral DMARDs, like methotrexate or guess aprimolast, that biologics significantly reduced both MACI events and mortality events somewhere between five and ten percent. And that was a significant reduction when you consider it's hundreds of thousands of patients. But is it real? Again, sometimes when you can't do the real trial, you do the best you can with either meta analyses, or registries, or even this sort of, you know, TriNetX EHR kind of study.
But in fact, these are not grade A evidence. These are like grade C evidence, and at best these are data that are supportive of a hypothesis upon which you should design a larger trial. I know you don't talk a lot about, or don't even want to think about fibromyalgia. We see a lot of it in rheumatology. I put up a report this week that said amongst the psoriatic arthritis patients, fibromyalgia is seen, according to systematic reviews eighteen percent of the time.
There's a range of, you know, ten to sixty percent, but the sort of the median seems to be eighteen percent. And you know what? You're going to see that in psoriasis as well. Why is this important? Well, if the psoriatic patient also has fibromyalgia, they have higher disease activity scores related to the fibromyalgia more so than inflammation.
If you have fibromyalgia, there's worse disease outcomes, there's poorer response to systemic therapies, they're unable to achieve your superlative disease activity states, and it's just a bad contributor. Fibromyalgia you would identify as someone who has a lot of complaints, widespread pain, and problems with sleep. You can refer them to a rheumatologist for further documentation of the diagnosis and how to treat that, because it's going to screw up your clinical results in practice and what you're trying to do to control their psoriasis. JAMA this week put out, or this month put out, a patient education page on eosinophilic fasciitis. I think it's a nice resource that you can have and hand out to your patients.
This is rare, you know, I haven't seen an EF patient in about five years, But it's in the differential diagnosis of skin thickening, as you know. It starts out with both swelling and redness in the limbs, arms and legs. Later that swelling or edema becomes thickening of skin and, you know, leathery skin. But it's got that peau de orange, that stippled orange peel like appearance. And the other distinguishing feature of this, they do not have Raynaud's, and that really doesn't involve this fingers or toes like scleroderma and scleroderma variants will.
Obviously the diagnosis is often made by you when we send them to you for a full thickness skin biopsy. A number of reports on lupus reveal. Last week we talked last year, last month, our last podcast we talked about the SC Tulip trial, which was subcutaneous anifrolumab being used in lupus, and in skin lupus, it seemed to work very well. This is another study, a real world study, called the REVEAL study of two thirty six lupus patients who initiated anifrolumab. Half the patients had musculoskeletal complaints, but two thirds had mucocutaneous disease.
Going in, they had a SLEDAI score of seven By six months twenty six percent achieved remission, two thirds had, low disease activity state called an LL DOS, and this seems to have a rapid onset of action. Why is this important? Because anifrolimab seems to be great in cutaneous lupus, may also be great in cutaneous dermatomyositis. But and it's an alpha interferon inhibitor, given as an infusion. As you remember last month, we told you about the FDA issuing a complete response letter, CRL, to AstraZeneca, the manufacturer of anifrolumab, but all that means is it says halt, and they were slowing down the BLA application for approval of anifrolumab, also called safnello, for use as a subcutaneous administration in lupus.
Interesting that the FDA has done that, while the EMA in Europe has already approved it. But further news on this complete response letter, which doesn't mean complete response, it means hold on, we're gonna reanalyze your data, It actually was issued to the company back in October '25. It wasn't announced until February, and the FDA was citing critical quality data, especially data on safety from that SC Tulip trial. Nonetheless, they do expect a decision on this BLA, an extended indication, sometime in the 2026. Another last key study, that's relevant to, you is a New England Journal published the Obenetuzumab inactive non renal lupus in the New England Journal, this past month.
This was a study of three zero three lupus patients who did not have glomerulonephritis, and many of them had active skin and musculoskeletal disease. The endpoint in this trial was an SRI-four response, that includes the sleet eye, and other measures. Obinutuzumab, the IL-twenty intravenous IL- I'm sorry, not IL-twenty. The intravenous anti CD20 B cell depleter showed an efficacy of seventy seven percent, placebo response rate of fifty four percent, a twenty three percent delta or treatment effect difference that was highly significant. Both the primary and secondary endpoints all favored obinutuzumab, that included the Bicla, reduction of steroid dose, sustained SRI4 responses, SRI6 responses, and also flare rates.
So again this is another option in the management of non renal lupus which could include problematic skin disease relevant to what we all do. That's it for this week on the Derm on RheumNow podcast. Please give us a good review, Please sign up at, roomnow.com to receive our news either weekly or daily, or you can sign up for the psoriatic, news that would come to you once a week and or the lupus news that would also come come to you once a week. Go to rheumnow.com and sign up. Take care.
We'll talk next month.
The focus is practical use, real world efficacy, knowing the side effects, knowing the advances. We hope that you can follow this news on roomnow.com. You can go there, sign up for either the daily email that we send to everyone, which has sort of five news items every day, or a weekly email, or even a topic email. This week on the podcast, many FDA regulatory decisions on psoriatic disease and lupus. A reminder about eosinophilic fasciitis, and also should you worry about fibromyalgia.
At the top of the list is the FDA approval of an oral IL-twenty three inhibitor, icotrokinra icotrokinra for plaque psoriasis. It was approved just recently this month for use in moderate to severe plaque psoriasis in adults, but also in children aged 12 and over who are at least forty kilograms in weight. To be eligible you need to be a candidate for systemic therapy or phototherapy. There's a new package insert that you can consult, and basically it tells you the drug looks pretty safe. It starts working at four weeks, it seems to have maximal responses by sixteen weeks as far as posse 90 responses.
The starting dose and usual daily dose is two hundred milligrams orally given every day and given thirty minutes before food. Looks like you need an empty stomach to get full absorption. Approval is based on four ICONIC trials, they're called the ICONIC trials, that these phase three trials showed efficacy and safety in over two thousand five hundred adults and adolescents with either active plaque psoriasis, but also there were sub studies on scalp psoriasis and genital psoriasis, and there were also two studies against other drugs, that you use, including ducravacitinib and ustekinumab. The trials basically showed that nearly seventy percent of people have, almost complete clearing of their skin, and at least fifty five percent achieve a PASI 90 by week sixteen. Major advance for you, we're waiting to see what it's going to do in psoriatic arthritis where there are trials going on right now.
FDA also active in pediatric disease by approving secukinumab for kids over the age of 12 with moderate to severe hidradenitis suppurativa. As you know, secukinumab is already approved for adults with hidradenitis. The FDA has also accepted the supplemental BLA biologics application for tildrakizumab, the IL-twenty three inhibitor for use in psoriatic arthritis. Of course it's approved already for use in psoriasis as an IL-twenty three inhibitor. A supplemental BLA biologic license application, means they want to amend their indication list and add this to the list based on the data and they're developing that data.
Also approved this month was ducravacitinib, the TYK2 inhibitor, for use in psoriatic arthritis. Currently available in psoriasis, now it's available for psoriatic arthritis. This happened on March 6. The indication is adults with active PSA based on the results of two phase three POETK PSA1, PSA2 trials showing efficacy and safety. I think this is a nice addition.
TYK2 inhibitors will sort of round out the oral options for patients with psoriatic arthritis. The other big news, at least for us rheumatologists, was UCB announcing in a press release the top line results of their B BOLD study. UCB makes bimekizumab the dual IL-seventeen inhibitor of IL-17A and F. This was a head to head trial of bimekizumab against the IL-twenty three inhibitor, rizenkizumab, five fifty three patients showing with a primary endpoint of an ACR 50, which is a pretty good response, sort of like your PASI 90, at week sixteen they had favorable results against of the bimekizumab IL-seventeen against IL-twenty three. The patients had to be either biologic naive at entry or they could have been exposed to one, but a max of one TNF inhibitor.
We don't have the details and data, but we don't have head to head trials like you do in dermatology. You guys, I think, are smarter and more aggressive in seeing who the top dog is, what's your go to drug when your first option may not work as well. Rheumatology, we have very few, you can count them on one hand, number of head to head trials, and certainly very few in psoriatic disease. This sort of is a retrospective network analysis using the Trinetix. I don't know if you're familiar with the Trinetix network.
This is a linkage of many EMRs, and they do studies that involve hundreds of thousands of patients. And they do propensity matching, and maybe they give us data that you can't get otherwise. But this is sort of simulated data, not real data. It's not a real clinical trial, it's not even a real registry. They're just finding out what's out there, and then trying to correct for it with propensity matching.
Well, anyway, in this study of one hundred and twenty three thousand adult psoriatic arthritis patients who were matched against non PSA controls, also twenty three one hundred and twenty three thousand, they showed what you already know: that psoriatic disease is associated with a significantly higher cardiovascular morbidity and mortality. MACE events are seventy four percent higher mortality is a doubling of events. Heart failure almost a doubling of events. MI seventy one percent higher. CVA forty nine percent higher.
And this was all in psoriatic arthritis patients, not psoriasis, where maybe the inflammation burden might be even higher. The other thing that was important about this analysis was that when they compared patients treated with biologic DMARDs versus conventional oral DMARDs, like methotrexate or guess aprimolast, that biologics significantly reduced both MACI events and mortality events somewhere between five and ten percent. And that was a significant reduction when you consider it's hundreds of thousands of patients. But is it real? Again, sometimes when you can't do the real trial, you do the best you can with either meta analyses, or registries, or even this sort of, you know, TriNetX EHR kind of study.
But in fact, these are not grade A evidence. These are like grade C evidence, and at best these are data that are supportive of a hypothesis upon which you should design a larger trial. I know you don't talk a lot about, or don't even want to think about fibromyalgia. We see a lot of it in rheumatology. I put up a report this week that said amongst the psoriatic arthritis patients, fibromyalgia is seen, according to systematic reviews eighteen percent of the time.
There's a range of, you know, ten to sixty percent, but the sort of the median seems to be eighteen percent. And you know what? You're going to see that in psoriasis as well. Why is this important? Well, if the psoriatic patient also has fibromyalgia, they have higher disease activity scores related to the fibromyalgia more so than inflammation.
If you have fibromyalgia, there's worse disease outcomes, there's poorer response to systemic therapies, they're unable to achieve your superlative disease activity states, and it's just a bad contributor. Fibromyalgia you would identify as someone who has a lot of complaints, widespread pain, and problems with sleep. You can refer them to a rheumatologist for further documentation of the diagnosis and how to treat that, because it's going to screw up your clinical results in practice and what you're trying to do to control their psoriasis. JAMA this week put out, or this month put out, a patient education page on eosinophilic fasciitis. I think it's a nice resource that you can have and hand out to your patients.
This is rare, you know, I haven't seen an EF patient in about five years, But it's in the differential diagnosis of skin thickening, as you know. It starts out with both swelling and redness in the limbs, arms and legs. Later that swelling or edema becomes thickening of skin and, you know, leathery skin. But it's got that peau de orange, that stippled orange peel like appearance. And the other distinguishing feature of this, they do not have Raynaud's, and that really doesn't involve this fingers or toes like scleroderma and scleroderma variants will.
Obviously the diagnosis is often made by you when we send them to you for a full thickness skin biopsy. A number of reports on lupus reveal. Last week we talked last year, last month, our last podcast we talked about the SC Tulip trial, which was subcutaneous anifrolumab being used in lupus, and in skin lupus, it seemed to work very well. This is another study, a real world study, called the REVEAL study of two thirty six lupus patients who initiated anifrolumab. Half the patients had musculoskeletal complaints, but two thirds had mucocutaneous disease.
Going in, they had a SLEDAI score of seven By six months twenty six percent achieved remission, two thirds had, low disease activity state called an LL DOS, and this seems to have a rapid onset of action. Why is this important? Because anifrolimab seems to be great in cutaneous lupus, may also be great in cutaneous dermatomyositis. But and it's an alpha interferon inhibitor, given as an infusion. As you remember last month, we told you about the FDA issuing a complete response letter, CRL, to AstraZeneca, the manufacturer of anifrolumab, but all that means is it says halt, and they were slowing down the BLA application for approval of anifrolumab, also called safnello, for use as a subcutaneous administration in lupus.
Interesting that the FDA has done that, while the EMA in Europe has already approved it. But further news on this complete response letter, which doesn't mean complete response, it means hold on, we're gonna reanalyze your data, It actually was issued to the company back in October '25. It wasn't announced until February, and the FDA was citing critical quality data, especially data on safety from that SC Tulip trial. Nonetheless, they do expect a decision on this BLA, an extended indication, sometime in the 2026. Another last key study, that's relevant to, you is a New England Journal published the Obenetuzumab inactive non renal lupus in the New England Journal, this past month.
This was a study of three zero three lupus patients who did not have glomerulonephritis, and many of them had active skin and musculoskeletal disease. The endpoint in this trial was an SRI-four response, that includes the sleet eye, and other measures. Obinutuzumab, the IL-twenty intravenous IL- I'm sorry, not IL-twenty. The intravenous anti CD20 B cell depleter showed an efficacy of seventy seven percent, placebo response rate of fifty four percent, a twenty three percent delta or treatment effect difference that was highly significant. Both the primary and secondary endpoints all favored obinutuzumab, that included the Bicla, reduction of steroid dose, sustained SRI4 responses, SRI6 responses, and also flare rates.
So again this is another option in the management of non renal lupus which could include problematic skin disease relevant to what we all do. That's it for this week on the Derm on RheumNow podcast. Please give us a good review, Please sign up at, roomnow.com to receive our news either weekly or daily, or you can sign up for the psoriatic, news that would come to you once a week and or the lupus news that would also come come to you once a week. Go to rheumnow.com and sign up. Take care.
We'll talk next month.



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