Vedolizumab, adalimumab, and golimumab compared

In real-life Italian data comparing clinical effectiveness of vedolizumab, adalimumab, and golimumab in ulcerative colitis (UC) patients, vedolizumab was superior to both anti-TNF agents in achieving clinical benefit at 52 weeks, and also in terms of treatment persistence [1].

The clinical endpoints were steroid-free clinical remission (partial Mayo score <2 without steroid use) and clinical response (reduction of the partial Mayo score ≥2 points with a concomitant decrease of steroid dosage compared with baseline). A total of 463 patients were included (vedolizumab, n=187; adalimumab, n=168; golimumab, n=108). Median follow-up was 47.6 weeks.

After 8 weeks, a clinical benefit was achieved in 70.6%, 68.5%, and 67.6% of patients in the vedolizumab, adalimumab, and golimumab group, respectively. After 52 weeks, vedolizumab showed better rates of clinical benefit than adalimumab (71.6% vs 47.5; P<0.001) and golimumab (71.6% vs 40.2%; P<0.001); there was no significant difference between adalimumab and golimumab. In the vedolizumab group, the risk of treatment discontinuation was lower than in the adalimumab group (HR 0.42; P<0.001) and golimumab (HR 0.30; P<0.001). Post-treatment mucosal healing rate was non-significantly better in the vedolizumab group (48.1%) versus the adalimumab and golimumab groups (38.0% and 34.6%, respectively).

Another Italian real-life study also compared efficacy of vedolizumab, adalimumab, and golimumab, but they added infliximab originator (IFX-O) as well as infliximab biosimilar (CTP-13) [2]. The primary endpoint was relapse-free, optimisation-free, steroid-free remission at 1 year, defined as Mayo partial score ≤2, with bleeding subscore 0, no relapse after first clinical remission and no optimisation with dose intensification or steroid courses. A total of 492 patients were included.

Overall, 65% achieved clinical remission during follow-up, with infliximab originator performing better than golimumab and vedolizumab. Relapse rate was lowest in the vedolizumab group. Based on the strict definition of clinical remission, all biologics appeared equally effective at 1 year, except when comparing golimumab with infliximab originator. Infliximab originator also appeared more effective in other clinical outcomes (see Table). CTP-13 had more frequent adverse events (mainly infusion reactions) than the other drugs. The authors claimed that infliximab originator should be used as the reference drug in head-to-head, controlled, comparison trials of biologicals in UC.

Table. Primary and secondary outcomes [2]

1. 
   
   1. Macaluso FS, et al. ECCO-IBD 2020, P690.
   2. Cassinotti A, et al. ECCO-IBD 2020, P566.

 



Posted on 14 April, 202012 November, 2020