There are no significant differences in efficacy between ustekinumab and vedolizumab for treating extraintestinal manifestations (EIM) in patients with inflammatory bowel disease (IBD), according to study findings in Digestive and Liver Disease.
Researchers conducted a retrospective cohort study in adult patients diagnosed with Crohn disease or ulcerative colitis (UC) treated with either vedolizumab or ustekinumab and who had developed EIM before treatment. For the analysis, researchers gathered demographic data, IBD phenotype, information on previous treatments, and duration of disease. Harvey-Bradshaw Index (HBI), Simple Clinical Colitis Activity Index, C-reactive protein levels, and calprotectin values were also collected.
EIM was characterized by the following: arthralgia or arthritis, back pain and sacroiliitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, uveitis, or episcleritis. Clinical response was defined as improvement or remission of EIM symptoms, subjectively described by the patient or from physician assessment.
The primary outcome was a clinical response to treatment at weeks 26 to 52. Secondary outcomes were steroid-free clinical response and clinical response of arthralgia at weeks 26 to 52.
Of 565 patients identified, researchers included 111 (ustekinumab, n=53; vedolizumab, n=58) in the study.
Patients in the ustekinumab and vedolizumab groups had a mean age (SD) of 28 and 33 years and had 60% and 50% women, respectively.
In the study population, patients treated with ustekinumab were more likely to be anti-TNF-experienced (96%) compared with patients treated with vedolizumab (58%; P <.0001 for both groups).
There were more patients with UC in the vedolizumab vs ustekinumab group (20% vs 2%; P <.002).
The clinical response of disease was similar between the study groups throughout the trial. After 26 weeks of treatment, clinical response rates between the ustekinumab and vedolizumab groups were 41% and 50%, respectively. At week 52, clinical response was observed in 44% and 42% of patients in the ustekinumab and vedolizumab groups, respectively.
EIM improvement at 26 weeks in the ustekinumab and vedolizumab groups was 33% and 39% (P =.5 for both groups). There were no significant differences in EIM improvement at 52 weeks between the ustekinumab (36%) and vedolizumab groups (34%; P =.9 for both groups).
There were no differences between vedolizumab and ustekinumab in achieving steroid-free clinical response at week 26 (37.5% vs 23%, respectively (P =.1). At 52 weeks, 30% vs 28% achieved steroid-free clinical response between the vedolizumab and ustekinumab groups, respectively (P =.8).
In the vedolizumab group, 8 patients (15%) experienced non-IBD associated arthralgia (fibromyalgia) compared with 7 patients (13%) in the ustekinumab group (P =.7).
Of the patients treated with ustekinumab, 7 patients (13%) experienced primary treatment failure resulting in therapy change, 2 patients discontinued treatment according to their own discretion, 2 patients received surgical procedures due to an IBD exacerbation, 1 patient developed colorectal carcinoma, and 1 patient died from a non-IBD related cause.
Among the patients treated with vedolizumab, 7 patients (12%) were unresponsive to treatment, 2 patients developed adverse effects, 2 patients stopped at their own discretion, and 1 patient was lost to follow-up.
Study limitations include a small cohort size, missing data, bias towards severe and unresponsive patients, and a negative bias towards ustekinumab treatment.
“There was no difference between vedolizumab and ustekinumab regarding their effect on EIM,” the study authors noted. “Both treatments showed promising good results in patients with EIM, especially with articular complaints with the exception of axial spondylarthritis.”
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Livne-Margolin M, Ling D, Attia-Konyo S, et al. Ustekinumab and vedolizumab for extraintestinal manifestations in inflammatory bowel disease-a retrospective study. Dig Liver Dis. Published online October 11, 2022. doi:10.1016/j.dld.2022.09.009