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.

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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.

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Analysis of the impact of tofacitinib treatment on weight and body mass index in patients with rheumatoid arthritis

ACR Open Rheumatology 2025;7:e70040 DOI: 10.1002/acr2.70040

Wollenhaupt et al. undertook a post-hoc analysis of data from eight Phase 3 and 3b/4 clinical trials to assess change from baseline (Δ) weight and BMI in patients with moderate to severe RA receiving TOF through 12 months. Additionally, Wollenhaupt et al. evaluated correlations between baseline/changes in disease activity, baseline CRP, and changes in lipids with Δweight and BMI. Wollenhaupt et al. showed that mean Δweight and BMI increased over time and were greater with TOF (all doses) versus placebo at Months 3 and 6, and with TOF monotherapy versus combination therapy, at Months 3, 6, and 12. The correlation and sensitivity analyses showed weak correlation between Δweight or BMI with TOF and DAS28-4(ESR), baseline CRP or lipid changes.

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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.

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Long-term safety of bimekizumab in adult patients with axial spondyloarthritis or psoriatic arthritis: pooled results from integrated phase IIb/III clinical studies

RMD Open. 2025;11:e005026. doi: 10.1136/rmdopen-2024-005026.

Mease et al. found that bimekizumab demonstrated a favourable long-term safety profile in patients with axSpA and PsA.

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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.

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March 2025

Guselkumab for the treatment of moderate-to-severe plaque psoriasis in paediatric patients: results of the phase III randomised placebo-controlled PROTOSTAR study

Br J Dermatol 2025;192:618–628 doi: 10.1093/bjd/ljae502

Prajapati et al. conducted the PROTOSTAR trial to assess guselkumab in paediatric patients with moderate-to-severe plaque psoriasis. Guselkumab significantly improved skin clearance versus placebo at Wk16, with high response rates sustained through Wk52 and a favourable safety profile.

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February 2025

Safety and efficacy of deucravacitinib in moderate to severe plaque psoriasis for up to 3 years: An open-label extension of randomized clinical trials

JAMA Dermatology 2025;161:56–66 doi: 10.1001/jamadermatol.2024.4688

Armstrong et al. evaluated the long-term safety and efficacy of deucravacitinib in patients with moderate to severe plaque psoriasis over a three-year period. The study found that exposure-adjusted incidence rates of AEs remained stable or declined over time, with no new safety signals emerging. Clinical response rates, including PASI75/90, were maintained, supporting the drug’s long-term efficacy.

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Upadacitinib in active non-radiographic axial spondyloarthritis: 2-year data from the phase 3 SELECT-AXIS 2 study

Arthritis Res Ther. 2025;27:23. doi: 10.1186/s13075-024-03441-3

Van den Bosch et al. reported that upadacitinib 15 mg once daily led to sustained improvement in nr-axSpA over two years, including disease activity, pain, and quality of life. The study reports that 57.1% achieved ASAS40 response at week 104, with no new safety signals identified.

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Achievement of endoscopic remission after induction reduces hospitalization burden in Crohn’s Disease: findings from a pooled post hoc analysis of risankizumab and upadacitinib Phase III trials

J Crohns Colitis. 2025 Feb 4;19(2):jjae128. doi: 10.1093/ecco-jcc/jjae128.

Panaccione et al. investigated the association between achievement of endoscopic remission following induction therapy and hospitalisation outcomes in Crohn’s disease. Patients achieving endoscopic remission at Week 12 experienced a 55% reduction in Crohn’s disease-related hospitalisation rates over the 52-week maintenance period. The results support endoscopic remission as an early therapeutic target.

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