Vedolizumab–tofacitinib combo induces response in refractory UC

Patients with ulcerative colitis (UC) refractory to anti-TNF and second-line therapies appear to benefit from combination therapy with vedolizumab plus tofacitinib, with many of them achieving clinical remission, as shown in a study.

The study included 91 patients with moderate-to-severe disease activity (Mayo score 6–12). These patients were randomly assigned to receive vedolizumab (n=38) or tofacitinib (n=40), and those who showed no response were given the combination therapy. All of them were followed for 24 weeks.

The primary endpoint was a combined clinical response and corticosteroid-free remission at week 24. Clinical response and remission at week 8, endoscopic remission at week 24, and incidence and severity of treatment-related adverse events were also evaluated as secondary outcomes.

Nonresponse occurred in 14 patients in the vedolizumab group and 15 in the tofacitinib group. Of these, 24 received combination therapy with vedolizumab plus tofacitinib with a mean follow-up of 34 weeks. The median duration of second-line therapy before the combination was 21 weeks. Five patients showed no response to the combination and received alternative interventions or were lost to follow-up.

At week 8, 17 patients achieved clinical response and five achieved remission with the combination. Colectomy was performed in three patients. At week 24, response and corticosteroid-free remission occurred in 17 and 14 patients, respectively, including seven who achieved endoscopic remission.

The combination also resulted in significant improvement in Mayo scores (mean difference, 5.33; p<0.01). Pseudomembranous colitis occurred in two patients, but these cases were resolved with vancomycin. None of the patients had severe adverse events.