Prospective Study Finds Adalimumab Biosimilars Effective in IBD, but Fall Short of Infliximab Product

A study published in Plos One finds that approved adalimumab biosimilars, Hulio and Hyrimoz, were safe and effective in treating patients with inflammatory bowel disease. (IBD).

Although they found the pair of biosimilars performed as well as others that have been evaluated in IBD, they concluded that the adalimumab biosimilars were less effective in IBD than an infliximab biosimilar previously studied.

Hulio, by Viatris, and Hyrimoz, by Sandoz, are approved in both the European Union and the United States, referenced to AbbVie’s Humira, although they are not scheduled to launch in the United States until 2023. According to the authors, adalimumab is used in multiple inflammatory conditions, but “Relatively few prospective studies with biosimilar adalimumab in patients with IBD have been published.”

The study examined use of the 2 biosimilars in 34 patients with Crohn disease (CD) and 16 with ulcerative colitis (UC), before and after 12 weeks of treatment. Investigators also logged weight changed, laboratory tests, and any adverse events (AEs). Therapy effectiveness was scored using the Crohn’s Disease Activity Index (CDAI) or the Mayo Scoring System (MSS), respectively.

During the study, 22 patients received Hulio and 28 received Hyrimoz subcutaneously, in what the investigators called a “classical” dosing scheme: week 0 (160 mg), week 2 (80 mg), week 4 (40 mg), week 6 (40 mg), week 8 (40 mg), week 10 (40 mg) and week 12 (40 mg).

Effectiveness

Among the CD patients, 25 (73.5%) were deemed in remission and 4 patients (11.8%) had a partial response after 12 weeks. Four patients (11.8%) were classified as nonresponders, and 1 discontinued prior to week 12 due to an AE (paraesthesia of all extremities). Median CDAI value prior to therapy was 216.0, which decreased to 110.0 (P < .0001) after 12 weeks of treatment.

Among the UC patients, 3 (18.8%) achieved remission, 7 (43.8%) had partial responses at 12 weeks, 4 (25%) had no response, and 2 discontinued therapy, due to allergic reaction. Median MSS value in the UC group before therapy was 8.0, which decreased to 4.0 (P = .0003) after 12 weeks.

In the discussion, the authors stated that these results were consistent with effectiveness of other adalimumab biosimilars in CD and UB, including Exemptia. There was no statistical difference between the 2 biosimilars within the study, the authors reported.

Comparison with infliximab biosimilar

Then, the authors compared results for the new study of the adalimumab biosimilars with their prior study of the infliximab biosimlar, CT-P13, approved by the FDA as Inflectra and referenced to Remicade. Because of the similarity in design between the 2 studies, they said such as comparison in evaluating effectiveness in IBD would be “highly interesting.”

The study with infliximab biosimilar Inflectra had found that in patients with CD, at 14 weeks, “remission was achieved in 50.0% of cases with partial response in the remaining 50.0%.”

In UC, the infliximab biosimilar had produced remission in 40.9% at 14 weeks, and a partial response in 54.5%.

“Based on these results, induction therapy with biosimilar infliximab CT-P13 appears to be more effective in inducing remission in patients with both CD and UC rather than induction therapy with biosimilar adalimumab. To the best of our knowledge, this seems to be the first comparison of biosimilar infliximab and biosimilar adalimumab in induction remission.”

Reference

Wasserbauer M, Hlava S, Drabek J, Stovicek J, Minarikova P, Nedbalova L, et al. Adalimumab biosimilars in the therapy of Crohn´s disease and ulcerative colitis: Prospective multicentric clinical monitoring. PLoS ONE. 2022;17(8):e0271299. doi:10.1371/journal.pone.0271299