Long-Term Safety of Upadacitinib in Patients With Inflammatory Bowel Disease: Integrated Analysis of Phase 2/3 Studies.
Remo Panaccione, Julián Panés, Laurent Peyrin-Biroulet et al.
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In 30 seconds
This integrated safety analysis pooled six phase 2/3 trials of upadacitinib in patients with ulcerative colitis or Crohn’s disease. It assessed 45 mg once-daily induction and 15 mg or 30 mg maintenance/long-term extension treatment, with adverse events reported per 100 patient-years. During maintenance/extension, cumulative upadacitinib exposure was 5149.3 patient-years. Overall adverse-event incidence was comparable with placebo, while serious or severe events and events leading to treatment discontinuation were lower with upadacitinib. The authors concluded that long-term treatment was generally well tolerated.
Key findings
- During maintenance/extension, venous thromboembolism rates were 0.3/0.4 vs 0 E/100 PY for upadacitinib 15/30 mg vs placebo.
- Gastrointestinal perforation rates were 0.4/<0.1 vs 0.8 E/100 PY for upadacitinib 15/30 mg vs placebo.
- Rates of adverse events leading to death were 0.2/<0.1 vs 0 E/100 PY for upadacitinib 15/30 mg vs placebo.
- Herpes zoster, neutropenia, lymphopenia, creatine phosphokinase elevation, hepatic disorder, and COVID-19 were more frequent across upadacitinib groups than with placebo.
Why it matters
Long-term safety information is important when considering therapies for chronic inflammatory bowel disease. These pooled trial data provide exposure-adjusted estimates for selected adverse events and suggest that overall adverse-event incidence was similar to placebo, while identifying events that occurred more often with upadacitinib and warrant attention in safety assessment.
What to keep in mind
The analysis integrates six trials with differing treatment phases and exposure durations; the abstract does not provide detailed event counts or comparative statistical estimates for the reported safety outcomes.