July 2025

Roflumilast foam, 0.3%, for psoriasis of the scalp and body the ARRECTOR Phase 3 randomized clinical trial

JAMA Dermatol 2025;7:698–706 doi: 10.1001/jamadermatol.2025.1136

Gooderham et al. observed that roflumilast foam, 0.3%, improved signs and symptoms of PsO on the scalp and body, including pruritus, with low rates of AEs in patients ≥12 years of age. Authors assessed efficacy and safety of roflumilast foam, 0.3%, versus vehicle administered QD for 8 weeks in patients with PsO of the scalp and body.

Keywords:

A randomized Phase II study of efmarodocokin alfa, an interleukin-22 agonist, versus vedolizumab in patients with ulcerative colitis

Clinical Gastroenterology and Hepatology 2025;23:1387–1397 doi: 10.1016/j.cgh.2024.11.013

Danese et al. observed that efmarodocokin alfa did not demonstrate efficacy compared to the PBO, and this Phase II study ended early for futility; however, there was evidence of target engagement (skin AEs, regenerating islet derived protein 3-alpha).

Keywords:

Benefit–risk analysis of upadacitinib versus adalimumab in patients with rheumatoid arthritis and higher or lower risk of cardiovascular disease

RMD Open 2025;11:e005371 doi: 10.1136/rmdopen-2024-005371

Burmester et al. provide insights into the benefit–risk profiles of UPA and adalimumab in patients with varying cardiovascular (CV) risks, suggesting that UPA may offer efficacy advantages over adalimumab irrespective of baseline CV risk, with generally similar rates of AEs. To better understand the benefits and risks of RA treatments in patients with different background CV risk, Burmester et al. assessed the short-term and long-term benefit–risk profiles of UPA and adalimumab in patients enrolled in SELECT-COMPARE.

Keywords:

June 2025

Obefazimod in patients with moderate-to-severely active ulcerative colitis: efficacy and safety analysis from the 96-week open-label maintenance phase 2b study

Journal of Crohn's and Colitis 2025;19:jjaf074 doi: 10.1093/ecco-jcc/jjaf074

Vermeire et al. provides data that supports the long-term efficacy and safety of obefazimod 50mg QD, with a substantial proportion of patients achieving clinical remission at Weeks 48 and 96. Vermeire et al. evaluated the 2-year outcome data of an OLM study, which assessed the long-term safety and efficacy of obefazimod 50mg QD.

Keywords:

Long-term efficacy and safety of upadacitinib in patients with moderately to severely active ulcerative colitis: an interim analysis of the phase 3 U-ACTIVATE long-term extension study

Lancet Gastroenterol Hepatol 2025;10:507–19 doi: 10.1016/S2468-1253(25)00017-2

This interim analysis by Panaccione et al. supports the positive long–term risk–benefit profile for UPA 15mg and 30mg among patients with moderately to severely active UC. U–ACTIVATE is a Phase 3 LTE study evaluating the long-term safety and efficacy of UPA in patients with moderately to severely active UC who enrolled in the preceding induction and maintenance studies. Panaccione et al. reported the interim results from the U-ACTIVATE study after approximately 3 years of total treatment, showing that the risk–benefit profile of UPA in patients with moderately to severely active UC is favourable.

Keywords:

Upadacitinib as monotherapy in patients with rheumatoid arthritis and prior inadequate response to methotrexate: results at 260 weeks from the SELECT-MONOTHERAPY randomised study

RMD Open 2025;11:e005051 DOI: 10.1136/rmdopen-2024-005051

The SELECT-MONOTHERAPY study evaluated the safety and efficacy of UPA monotherapy through 260 weeks of treatment, in patients with RA who had prior inadequate response to MTX. No new safety signals were observed with long-term exposure to UPA, and results were consistent with prior findings and the established safety profile of UPA across indications. These data support the potential of UPA as a treatment option for patients with moderate to severe active RA who have responded inadequately to MTX.

Keywords:

May 2025

Efficacy and safety of zimlovisertib, ritlecitinib and tofacitinib, alone and in combination, in patients with moderate to severe rheumatoid arthritis and an inadequate response to methotrexate

Arthritis Rheumatol. 2025 doi: 10.1002/art.43184 Epub ahead of print

Phase 2 study data show that zimlovisertib + tofacitinib was more effective than tofacitinib alone, in patients with moderate-to-severe RA and an inadequate response to MTX.

Keywords:

April 2025

Efficacy and safety of tildrakizumab for the treatment of moderate-to-severe plaque psoriasis of the scalp: Week 52 results from a phase 3b, randomized, double-blind, placebo-controlled trial

J Am Acad Dermatol. 2025;92(4):816-824 doi: 10.1016/j.jaad.2024.12.018

The efficacy and safety of tildrakizumab for the treatment of scalp psoriasis are maintained for up to 52 weeks of treatment in a clinical trial setting.

Keywords:

Corticosteroid-sparing effects of risankizumab efficacy and safety in patients with moderately to severely active ulcerative colitis

J Crohns Colitis. 2025;19(4):jjaf025 doi: 10.1093/ecco-jcc/jjaf025

Reinisch W, et al. report that the efficacy of RZB induction therapy is independent of CS use, with high rates of CS-free outcomes observed in the overall population and among patients with baseline CS use.

Keywords: