Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2026
EFFICACY AND SAFETY OF ADVANCED THERAPIES AS INDUCTION THERAPY FOR ULCERATIVE COLITIS: AN UPDATED SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS.
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Olivera Pablo A, Lasa Juan S, Singh Siddharth, Jairath Vipul, Fumery Mathurin, Sands Bruce E, Danese Silvio, Peyrin-Biroulet Laurent
Аннотация
BACKGROUND & AIMS: Advanced therapies (ATs) are central to the management of moderate-to-severe ulcerative colitis (UC). The expanding therapeutic landscape and limited head-to-head trials necessitate updated comparative effectiveness analyses. We performed a systematic review and network meta-analysis (NMA) to assess the efficacy and safety of ATs as induction therapy for UC.
METHODS: We searched MEDLINE, Embase, and Cochrane CENTRAL. We included phase 3 randomized controlled trials evaluating approved ATs or agents in late-stage development for induction therapy in moderate-to-severe UC. Pairwise meta-analyses and NMA were conducted using a frequentist random-effects model. Confidence was evaluated using the CINeMA framework. The primary outcome was clinical remission; secondary outcomes included endoscopic improvement, serious adverse events (SAEs), adverse events leading to discontinuation (AELDs), and serious infections. Analyses were stratified by prior exposure to ATs.
RESULTS: Thirty-three induction trials involving 17 therapies, were included. Upadacitinib demonstrated the highest relative efficacy for clinical remission (RR 6.90; 95% CI 3.54-12.45; P-score 0.95; high confidence) and endoscopic improvement (RR 5.29; 95% CI 3.38-8.28; P-score 0.97; moderate confidence). In AT-naïve patients, obefazimod and upadacitinib showed the highest efficacy, whereas in AT-experienced patients, upadacitinib, ustekinumab, and tofacitinib ranked highest. Anti-p19 inhibitors, including risankizumab, subcutaneous guselkumab, and mirikizumab, were associated with the most favorable safety profiles for SAEs and AELDs, although confidence in safety estimates was lower.
CONCLUSIONS: Upadacitinib has high efficacy for induction of clinical remission and endoscopic improvement in AT-naïve and AT-experienced patients. Novel therapies, like obefazimod and guselkumab subcutaneous, may represent highly effective alternatives. Anti-p19 inhibitors offer a favorable safety profile.
METHODS: We searched MEDLINE, Embase, and Cochrane CENTRAL. We included phase 3 randomized controlled trials evaluating approved ATs or agents in late-stage development for induction therapy in moderate-to-severe UC. Pairwise meta-analyses and NMA were conducted using a frequentist random-effects model. Confidence was evaluated using the CINeMA framework. The primary outcome was clinical remission; secondary outcomes included endoscopic improvement, serious adverse events (SAEs), adverse events leading to discontinuation (AELDs), and serious infections. Analyses were stratified by prior exposure to ATs.
RESULTS: Thirty-three induction trials involving 17 therapies, were included. Upadacitinib demonstrated the highest relative efficacy for clinical remission (RR 6.90; 95% CI 3.54-12.45; P-score 0.95; high confidence) and endoscopic improvement (RR 5.29; 95% CI 3.38-8.28; P-score 0.97; moderate confidence). In AT-naïve patients, obefazimod and upadacitinib showed the highest efficacy, whereas in AT-experienced patients, upadacitinib, ustekinumab, and tofacitinib ranked highest. Anti-p19 inhibitors, including risankizumab, subcutaneous guselkumab, and mirikizumab, were associated with the most favorable safety profiles for SAEs and AELDs, although confidence in safety estimates was lower.
CONCLUSIONS: Upadacitinib has high efficacy for induction of clinical remission and endoscopic improvement in AT-naïve and AT-experienced patients. Novel therapies, like obefazimod and guselkumab subcutaneous, may represent highly effective alternatives. Anti-p19 inhibitors offer a favorable safety profile.