Clinical News Briefs

Randomized Trial Supports Sirolimus as Add-On Systemic Lupus Erythematosus Therapy

Adding sirolimus to standard treatment for active systemic lupus erythematosus improved disease control compared with placebo in a randomized phase 3 trial presented at the European Alliance of Associations for Rheumatology (EULAR) 2026 Annual Meeting. Patients receiving sirolimus were more likely to achieve a clinical response and showed greater improvement in disease activity and serologic markers. Treatment generally was well tolerated, although lipid abnormalities, leukopenia, and menstrual irregularities were more common. Sirolimus may become a useful oral option for refractory lupus, pending further confirmation and guidance.

Bimekizumab Trumps Risankizumab in Head-to-Head Psoriatic Arthritis Trial

Dual IL-17 blockade may offer greater joint benefit than IL-23 inhibition in psoriatic arthritis, potentially helping guide biologic selection for patients with skin and musculoskeletal disease. In the phase 3b BE BOLD trial, bimekizumab was more effective than risankizumab for joint disease, with more patients achieving a 50% improvement in American College of Rheumatology response criteria at 16 weeks. Bimekizumab also showed superior results across several secondary measures, including minimal disease activity and skin outcomes, while safety was broadly similar. The findings were presented at the EULAR 2026 Annual Meeting.

FDA Delays iPLEDGE Modifications Until November 2026

In a June 16 announcement, the US Food and Drug Administration said long-awaited modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy program for isotretinoin—originally set to take effect on August 8, 2026—will be delayed until November 15, 2026. The agency said the extra time will allow testing of the system updates, reduce technical problems, and help avoid interruptions in patient access to isotretinoin. The planned changes are intended to reduce burdens on patients, prescribers, and pharmacies while maintaining safety, and they include allowing at-home pregnancy testing in some cases. Until the new date, the Food and Drug Administration will continue enforcement discretion for pregnancy testing requirements. The update also clarifies that monthly counseling documentation for patients who cannot become pregnant will no longer be required and that pharmacy staff training must be completed annually. iPledge work group chair John Barbieri, MD, MBA, told Medscape Medical News, “It’s important to make sure any changes to the program are implemented in a way that is effective…. I would rather it be done sooner than later, but it’s important it be done right.”

Smoking May Lower Sjögren Disease Risk and Mask Pathology

New data presented at EULAR 2026 suggest that smoking may be associated with a lower likelihood of Sjögren disease and milder salivary gland inflammation, although tobacco is harmful in many autoimmune diseases. In a cohort undergoing salivary gland biopsy for sicca symptoms, current smokers were less likely to have Sjögren disease; among those with disease, smokers had less inflammation and fewer advanced germinal centers. The key takeaway is not that smoking is beneficial, but that tobacco exposure may alter disease phenotype and biopsy interpretation, potentially masking severity and affecting diagnosis.

Skin Disorders in Transgender Patients: Treatment Recommendations

Hormonal therapy in transgender patients can substantially affect skin disease patterns, particularly acne, hair loss, melasma, and possibly hidradenitis suppurativa. In transmasculine patients receiving testosterone, acne is the most common dermatologic complaint and often develops early; isotretinoin is most effective, although pregnancy potential must be considered. Testosterone also contributes to androgenetic alopecia, managed with minoxidil and sometimes finasteride. In transfeminine patients, facial hair and melasma are common concerns. Dermatologists should anticipate these effects and provide gender-affirming care with counseling, examination practices, and preventive treatment.