Abstract
Summary
This post hoc analysis of the UNITI studies found ustekinumab (UST) did not significantly improve overall extraintestinal manifestations (EIMs) of Crohn's disease compared to placebo‐treated patients at weeks 6 and 52.
Background and Aims
The UNITI trials demonstrated that UST was effective in inducing and maintaining clinical remission in Crohn's disease (CD). However, limited data exists regarding its effectiveness for treatment of EIMs. This post hoc analysis evaluated the efficacy of UST in treatment of EIMs.
Methods
Data from UNITI‐1/2 and IM‐UNITI (NCT01369329, NCT01369342, NCT01369355) were obtained from the Yale Open Data Access Project (2019‐4104). Nine hundred and fourty‐one patients eligible for UST induction and 263 patients eligible for maintenance UST were included. The primary outcome of interest was EIM resolution at Week 6 in UST and placebo‐treated patients using the chi‐square test. EIM resolution at Week 52 was also assessed. McNemar's test was used to compare the proportion of patients who reported active EIMs at weeks 6 and 52 versus baseline.
Results
From 941 UST‐treated patients in UNITI‐1/2, 504 had 527 EIMs at baseline. Overall, there was no significant difference in EIM resolution observed in UST‐treated patients (186/504, 36.9%) compared to placebo (90/230, 39.1%; p = 0.564) at Week 6. Patients treated with continuous UST (91/119, 76.4%) had no significant difference in overall EIMs resolved at Week 52 compared to placebo (72/90, 80.0%; p = 0.542). Although many EIMs demonstrated reduction in prevalence compared to baseline at initiation of UST, only erythema nodosum was more likely to improve at Week 52 on treatment versus placebo.
Conclusion
Overall, UST did not lead to significant resolution of EIMs for CD compared to placebo at weeks 6 and 52.
Key Summary
Summarise the established knowledge on this subject
Summarise the established knowledge on this subject
In a systematic review, ustekinumab was found to be effective in treating
dermatologic manifestations such as psoriasis, pyoderma gangrenosum and erythema nodosum, and rheumatologic manifestations such as arthralgias and psoriatic arthritis in IBD
However, existing evidence is limited due to retrospective evaluations, small sample sizes and lack of comparator groups
Overall, there is a paucity of data regarding the effectiveness of ustekinumab for treatment of extraintestinal manifestations in Crohn's disease
What are the significant and/or new findings of this study?
Patients with Crohn's disease treated with ustekinumab had overall no significant resolution of EIMs as compared to those treated with placebo at week 6 and week 52
Among individual EIMs, only erythema nodosum was significantly reduced in patients treated with ustekinumab at week 52 compared to placebo‐treated patients