The impact of ustekinumab on extraintestinal manifestations of Crohn's disease: A post hoc analysis of the UNITI studies

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 effec...

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Bibliographic Details
Published in:United European gastroenterology journal 2021-06, Vol.9 (5), p.581-589
Main Authors: Narula, Neeraj, Aruljothy, Achuthan, Wong, Emily C. L., Homenauth, Ravi, Alshahrani, Abdul‐Aziz, Marshall, John K., Reinisch, Walter
Format: Article
Language:English
Subjects:
Adult
Anemia
Arthralgia - drug therapy
Arthralgia - etiology
Arthritis - drug therapy
Arthritis - etiology
Clinical Trials as Topic
Crohn Disease - complications
Crohn Disease - drug therapy
Crohn's disease
Crohns disease
Cytokines
Erythema Nodosum - drug therapy
Erythema Nodosum - etiology
extraintestinal manifestations
Female
Fistula
Gastrointestinal Agents - administration & dosage
Gastrointestinal Agents - therapeutic use
Humans
Induction Chemotherapy
Inflammatory Bowel Disease
Iritis - drug therapy
Iritis - etiology
Maintenance Chemotherapy
Male
Original
Pathogenesis
Psoriasis
Psoriatic arthritis
Pyoderma Gangrenosum - drug therapy
Pyoderma Gangrenosum - etiology
Remission (Medicine)
resolution
ustekinumab
Ustekinumab - administration & dosage
Ustekinumab - therapeutic use
Uveitis - drug therapy
Uveitis - etiology
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Summary: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 st
ISSN:2050-6406
2050-6414
DOI:10.1002/ueg2.12094