healio.com
No new safety risks for upadacitinib in IBD at 3 years; uptick in herpes zoster in Crohn’s
This analysis summarizes longer-term safety data for upadacitinib (Rinvoq) in people with moderate to severe ulcerative colitis and Crohn’s disease.
If you or a clinician are weighing benefits and risks of JAK inhibitor therapy, these pooled trial data highlight overall tolerability and a noted increase in shingles risk.
Adults with moderate-to-severe UC or Crohn’s disease considering or taking upadacitinib, clinicians who manage IBD, and researchers following long-term safety of JAK inhibitors.
What To Know
Key finding: An integrated analysis of six clinical trials found no new safety risks for upadacitinib over up to about 3 years of follow-up overall, but there was an increased rate of herpes zoster (shingles), particularly at higher doses and among patients with Crohn’s disease.
The analysis pooled induction and maintenance/long-term-extension data and reported adverse events as events per 100 patient-years. Serious events such as adjudicated major adverse cardiac events (MACE), malignancy and venous thromboembolism were rare in the pooled IBD trial data.
Common adverse events included acne, nasopharyngitis, neutropenia/lymphopenia, transient liver enzyme elevations and COVID-19 during the pandemic period. Herpes zoster cases were generally described as mild and localized and occurred most often in unvaccinated patients.
What this does not say: The article summarizes a post hoc pooled safety analysis and notes limitations, including differing exposure times between placebo and upadacitinib groups and a trial population with few comorbidities.
It does not provide guidance to change individual treatment; vaccine history and individual risks should be discussed with a clinician. Where the data came from: Healio’s report summarizes an integrated analysis published in Clinical Gastroenterology and Hepatology by Panaccione and colleagues and commentary by Rubin and coauthors.
This is a pooled, post hoc clinical-trial safety analysis (not a randomized long-term head-to-head safety trial or real-world registry). Reported herpes zoster increases were more common at higher doses and among unvaccinated patients. The article notes limited comorbidity representation and shorter placebo exposure, so real-world studies may provide additional information.
