IBD Journal Scan
Key articles from high impact journals in last month
Editorial Recommendations
SEP-2025
VARSITY - Vedolizumab vs Adalimumab in UC
Biologic therapies are central to ulcerative colitis (UC) management, yet head-to-head comparisons remain scarce. This phase 3b, double-blind, randomized trial across 245 global centers evaluated vedolizumab versus adalimumab in adults with moderately to severely active UC. A total of 769 patients received either vedolizumab infusions or adalimumab injections over 52 weeks. The primary endpoint was clinical remission, defined by Mayo score criteria. At week 52, vedolizumab demonstrated superior efficacy: 31.3% achieved remission versus 22.5% with adalimumab. Endoscopic improvement also favored vedolizumab (39.7% vs. 27.7%). Corticosteroid-free remission was slightly higher with adalimumab, though differences were not statistically robust. Infection rates were lower with vedolizumab, including fewer serious infections. Overall, vedolizumab provided greater remission and mucosal healing, supporting its role as a first-line biologic option in UC.
GALAXI-2 and GALAXI-3 - Ustekinumab vs Guselkumab in CD
Suboptimal control remains a challenge in Crohn’s disease despite biologics. The phase 3 GALAXI-2 and GALAXI-3 trials evaluated guselkumab in 1,048 adults with moderately to severely active Crohn’s disease across 40 countries. Patients received intravenous induction followed by subcutaneous guselkumab (200 mg every 4 weeks or 100 mg every 8 weeks), ustekinumab, or placebo for 48 weeks. Guselkumab significantly outperformed placebo for both co-primary endpoints: clinical response at week 12 and clinical remission at week 48, as well as clinical response at week 12 and endoscopic response at week 48. Response rates reached up to 55% versus 12–13% with placebo. Safety outcomes were favorable, with lower rates of serious adverse events than placebo or ustekinumab. These findings support guselkumab as an effective long-term therapy for Crohn’s disease.
SEAVUE - Ustekinumab vs Adalimumab in Bio-Naive CD
Head-to-head biologic trials guide therapeutic choice in Crohn’s disease. The phase 3b SEAVUE trial compared ustekinumab and adalimumab monotherapy in biologic-naive adults with moderately to severely active Crohn’s disease. Conducted at 121 sites across 18 countries, 386 patients were randomized to ustekinumab (intravenous induction, then subcutaneous every 8 weeks) or adalimumab (standard dosing every 2 weeks) for 52 weeks. The primary endpoint was clinical remission (CDAI <150) at week 52. Remission was achieved by 65% of ustekinumab patients versus 61% with adalimumab (difference 4%, 95% CI –6 to 14; p=0.42). Safety profiles were consistent, with low rates of serious infections (2% vs 3%) and no deaths. Both therapies proved effective and well tolerated, with no statistically significant difference, offering patients two strong treatment options.
SEQUENCE - Ustekinumab vs Risankizumab in CD
Direct biologic comparisons are vital in Crohn’s disease management. This phase 3b, randomized, controlled trial compared risankizumab and ustekinumab in patients with moderate-to-severe Crohn’s disease who previously had inadequate response or intolerance to anti-TNF therapy. A total of 520 patients were randomized to receive standard dosing for 48 weeks, with blinded endpoint assessment. At week 24, risankizumab achieved noninferiority to ustekinumab for clinical remission (58.6% vs 39.5%; adjusted difference 18.4%, 95% CI 6.6– 30.3). At week 48, risankizumab was superior for endoscopic remission (31.8% vs 16.2%; difference 15.6%, 95% CI 8.4–22.9; P<0.001). Completion rates were higher with risankizumab (90.2% vs 72.8%), and adverse event incidence was similar between groups. These findings highlight risankizumab as a more effective alternative to ustekinumab for Crohn’s disease
VIVID 1 - Ustekinumab vs Mirkizumab in CD
The phase 3 VIVID-1 trial evaluated mirikizumab, an IL-23p19 inhibitor, in adults with moderately-toseverely active Crohn’s disease across 33 countries. A total of 1,150 patients were randomized to mirikizumab, ustekinumab, or placebo, with 1,065 included in the efficacy population. Patients received intravenous induction followed by subcutaneous maintenance therapy for 52 weeks. Both coprimary endpoints were met: endoscopic response-composite occurred in 38.0% of patients on mirikizumab versus 9.0% with placebo, while CDAI clinical remission-composite was achieved in 45.4% versus 19.6%, respectively (both p<0.0001). Safety was favorable, with adverse events and discontinuations lower than placebo, and serious events comparable to ustekinumab. COVID-19 was the most frequent event. Three deaths occurred, none treatment-related. Overall, mirikizumab demonstrated robust efficacy and a consistent safety profile, establishing it as an effective therapy for Crohn’s disease.
HIBISCUS - Ertolizumab vs Adalimumab or Placebo in UC
The phase 3 HIBISCUS I and II trials evaluated etrolizumab, a gut-targeted anti-β7 integrin antibody, in biologic-naive adults with moderately to severely active ulcerative colitis. Across 716 patients enrolled, participants were randomized to etrolizumab, adalimumab, or placebo. At week 10, etrolizumab showed superiority over placebo in HIBISCUS I (19.4% vs 6.9% remission; p=0.017) but not in HIBISCUS II (18.2% vs 11.1%; p=0.17). Pooled analyses demonstrated that etrolizumab was not superior to adalimumab for remission, clinical response, or endoscopic endpoints, though outcomes were numerically similar. Safety profiles were consistent across groups, with ulcerative colitis flare as the most common event. Serious adverse events were comparable between etrolizumab and placebo and slightly lower with adalimumab. Two deaths occurred in the etrolizumab arm, neither considered treatment-related
GARDENIA - Ertolizumab vs Infliximab in UC
The phase 3 GARDENIA trial compared etrolizumab, a gut-targeted anti-β7 integrin antibody, with infliximab in biologic-naive adults with moderately to severely active ulcerative colitis. Conducted across 114 global centers, 397 patients were randomized to etrolizumab or infliximab for 52 weeks. The primary endpoint required both clinical response at week 10 and clinical remission at week 54. Outcomes were similar between groups: 18.6% with etrolizumab versus 19.7% with infliximab (difference –0.9%, p=0.81). Adverse events were reported in 77% of etrolizumab patients and 76% with infliximab, with ulcerative colitis flare being most frequent. Serious adverse events, including infections, occurred more often with etrolizumab (16% vs 10%). One death occurred in the infliximab arm, unrelated to treatment. Overall, etrolizumab did not demonstrate superiority to infliximab, with comparable efficacy but slightly higher serious adverse events.