August 2025

Efficacy of risankizumab across GRAPPA domains in psoriatic arthritis: A pooled analysis of patients from the Phase 3 KEEPsAKE 1 and 2 studies

RMD Open 2025;11:e005522 Doi:10.1136/rmdopen-2025-005522

Treatment with risankizumab provides durable improvement in the signs and symptoms of PsA across all the GRAPPA disease domains and related conditions. This post hoc analysis by Coates et al. aimed to assess the efficacy of long-term treatment with risankizumab across the updated GRAPPA domains and key related conditions of PsA.

Keywords:

Comparative effectiveness and safety of adalimumab, secukinumab, and upadacitinib in psoriatic arthritis: A prospective cohort study based on PARWCH cohort

J Dermatol 2025 Doi: 10.1111/1346-8138.17906 Epub ahead of print

Wang et al. validated the effectiveness and safety of UPA in this real-world study of Chinese PsA patients. UPA demonstrated comparable effectiveness to secukinumab (SEC) in psoriatic lesion improvement while showing comparable joint symptom relief compared with adalimumab (ADA), coupled with a favourable safety profile.

Keywords:

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:

Anti-TL1A antibody, afimkibart, in moderately-to-severely active ulcerative colitis (TUSCANY-2): A multicentre, double-blind, treat-through, multi-dose, randomised, placebo-controlled, Phase 2b trial

Lancet Gastroenterol Hepatol 2025;10:882–95 Doi: 10.1016/S2468-1253(25)00129-3

Danese et al. report that in the TUSCANY-2 study, afimkibart showed a favourable
benefit–risk profile with clinically meaningful improvements and early onset of response during induction, sustained through maintenance, and an acceptable safety profile with no safety signals. Danese et al. describe results from the Phase 2b TUSCANY-2 trial that evaluated the safety and efficacy of 50mg, 150mg, and 450mg doses of afimkibart in adults with moderately-to-severely active UC.

Keywords:

Efficacy and safety of upadacitinib for patients with immune-mediated inflammatory diseases: a systematic review and meta-analysis

Front Immunol 2025;16:1586792 doi: 10.3389/fimmu.2025.1586792

UPA has shown effectiveness in treating IMIDs like RA, axSpA, PsA, CD, and UC. Chai et al. evaluated evidence from a synthesis of RCTs and provided insights that may guide clinical decision-making and improve treatment outcomes for IMIDs. UPA effectively alleviated symptoms, reduced disease activity, and showed notable benefits in improving quality of life.

Keywords:

June 2025

Clinical trial: Association between early disease clearance and long-term outcomes—4-year results from the Phase 3 UNIFI study of ustekinumab in ulcerative colitis

Alimentary Pharmacology & Therapeutics 2025;62:483–492 Doi: 10.1111/apt.70264

Danese et al. showed that patients who achieved disease clearance 8 weeks after ustekinumab induction were more likely to be in long-term clinical, symptomatic and quality of life remission with ustekinumab maintenance treatment than patients who did not. Authors evaluated disease clearance in the Phase 3 UNIFI program and its association with long-term outcomes.

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: