Impact of Treatment Response on Risk of Serious Infections in Patients with Crohn’s Disease: Secondary Analysis of the PYRAMID Registry
Abstract
Background and Aims: Traditional risk factors for serious infections with advanced therapies in patients with Crohn’s disease (CD) have been assessed at baseline prior to starting therapy. We evaluated the impact of treatment response on the risk of serious infections in adalimumab-treated patients with CD through secondary analysis of the PYRAMID registry (NCT00524537). Methods: We included patients with CD who initiated adalimumab and classified them as treatment responders (achieved steroid-free clinical remission based on patient-reported outcomes) vs. non-responders (not in steroid-free clinical remission) at 6m after treatment initiation (landmark). We compared the risk of serious infections between responders vs. non-responders between 6–36m after treatment initiation, through stabilized inverse probability of treatment weighted (IPW) Cox proportional hazards model. Results: Of 1515 adalimumab-treated patients, 763 (50.4%) were classified as responders at 6m (37±13y, 56% female, disease duration, 9.5±8.5y). Compared with non-responders, responders were less likely to have moderate to severe symptoms (55.6% vs. 33%), require steroids (45.5% vs. 17.3%) or opiates (6.6% vs. 1.3%) at baseline, without any differences in disease location, perianal disease, and prior CD complications. During follow-up, using stabilized IPW, responders were 34% less likely to experience serious infections compared with non-responders (HR,0.66; 95% CI,0.46–0.96). Risk of gastrointestinal and…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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