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-erythematosus
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