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Efficacy of biological therapies and small molecules in moderate to severe ulcerative colitis: systematic review and
Nicholas E Burr1,2, David J Gracie2, Christopher J Black2
1Department of Gastroenterology, Mid Yorkshire Hospitals NHS Trust, Wakefield, UK.
Objective:
Biological therapies and small molecules continue to be evaluated in moderate to severely active ulcerative colitis, but are often studied in placebo-controlled trials, meaning their relative efficacy and safety is unknown. We examined this in a network meta-analysis.
Design:
We searched the literature to October 2021 to identify eligible trials. We judged efficacy using clinical remission, endoscopic improvement, or clinical response, and according to previous exposure or non-exposure to antitumour necrosis factor (TNF)-α therapy. We also assessed safety. We used a random effects model and reported data as pooled relative risks (RRs) with 95% CIs. Interventions were ranked according to their P-score.
Results:
We identified 28 trials (12 504 patients). Based on failure to achieve clinical remission, upadacitinib 45 mg once daily ranked first versus placebo (RR 0.73; 95% CI 0.68 to 0.80, P-score 0.98), with infliximab 5 mg/kg and 10 mg/kg second and third, respectively. Upadacitinib ranked first for clinical remission in both patients naïve to anti-TNF-α drugs (RR 0.69; 95% CI 0.61 to 0.78, P-score 0.99) and previously exposed (RR 0.78; 95% CI 0.72 to 0.85, P-score 0.99). Upadacitinib was superior to almost all other drugs in these analyses. Based on failure to achieve endoscopic improvement infliximab 10 mg/kg ranked first (RR 0.61; 95% CI 0.51 to 0.72, P-score 0.97), with upadacitinib 45 mg once daily, second, and infliximab 5 mg/kg third. Upadacitinib was more likely to lead to adverse events, but serious adverse events were no more frequent, and withdrawals due to adverse events were significantly lower than with placebo. Infections were significantly more likely with tofacitinib than placebo (RR 1.41; 95% CI 1.03 to 1.91).
Conclusion:
In a network meta-analysis, upadacitinib 45 mg once daily ranked first for clinical remission in all patients, patients naïve to anti-TNF-α drugs and patients previously exposed. Infliximab 10 mg/kg ranked first for endoscopic improvement. Most drugs were safe and well tolerated.
Insights
Upadacitinib 45 mg once daily demonstrated superior clinical remission rates in ulcerative colitis patients compared to placebo. Infliximab 10 mg/kg was most effective for endoscopic improvement, with most treatments showing good safety profiles.
Area of Science:
- Gastroenterology
- Immunology
- Pharmacology
Background:
- Ulcerative colitis treatments like biological therapies and small molecules are under evaluation.
- Direct comparisons of their efficacy and safety are limited due to reliance on placebo-controlled trials.
Purpose of the Study:
- To conduct a network meta-analysis comparing the relative efficacy and safety of various treatments for moderate to severe ulcerative colitis.
- To rank interventions based on clinical remission, endoscopic improvement, and safety outcomes.
Main Methods:
- A systematic literature search identified eligible randomized controlled trials up to October 2021.
- Efficacy was assessed by clinical remission, endoscopic improvement, and clinical response, stratified by prior anti-tumour necrosis factor (TNF)-α exposure.
- Safety outcomes, including adverse events and withdrawals, were evaluated using a random-effects model.
Main Results:
- Upadacitinib 45 mg once daily ranked highest for clinical remission in all patient groups (naïve and previously exposed to anti-TNF-α therapy).
- Infliximab 10 mg/kg ranked highest for endoscopic improvement.
- While upadacitinib increased the likelihood of adverse events, serious adverse events and withdrawals due to adverse events were not significantly higher than placebo. Tofacitinib showed a higher incidence of infections.
Conclusions:
- Upadacitinib 45 mg once daily is a leading option for achieving clinical remission in ulcerative colitis patients.
- Infliximab 10 mg/kg is highly effective for endoscopic improvement.
- The majority of evaluated treatments demonstrated acceptable safety and tolerability profiles.
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