PANTS Study Supports Effectiveness, Safety, and Immunogenicity of Biosimilar Infliximab

Today, at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO), researchers released 12-month data from the Personalized Anti—Tumor Necrosis Factor (anti-TNF) Therapy in Crohn Disease (CD) Study (PANTS). The real-world data indicate that the clinical effectiveness, safety, and immunogenicity of the biosimilar infliximab CT-P13 (Inflectra, Remsima) in patients with CD is comparable with both the reference infliximab (Remicade) and adalimumab (Humira).

The PANTS study, conducted in the United Kingdom, was a 3-year, prospective, observational study that investigated primary non-response, loss of response, and adverse drug reactions to infliximab.

The study included 1601 patients with CD who had active disease and no prior therapy with anti-TNF agents. Primary non-response was defined as either a need for ongoing steroids at week 12 to week 14, or a failure of the patient’s Harvey-Bradshaw Index (HBI) score to fall by 3 or more points together with the failure of C-reactive protein to fall by 50% (or to 3 mg/l or below). Remission was defined at weeks 14 and 54 as an HBI score of 3 points or fewer, and CRP at 3 mg/l or below with no concomitant steroid use.

In total, 751 patients received reference infliximab, 200 received biosimilar infliximab, and 650 received adalimumab.

At week 12 to week 14, the rate of primary nonresponse was 21% in the reference infliximab group, 21% in the biosimilar infliximab group, and 26% in the adalimumab group, and was associated with older age, higher body mass index, and low drug levels.

At week 54, the remission rate was 40% in the reference infliximab group, 40% in the biosimilar infliximab group, and 34% in the adalimumab group, and the immunogenicity rate for the 3 groups was 26%, 28%, and 11%, respectively.

Immunogenicity was associated with non-remission at week 54 for all groups, but the use of immunomodulators reduced the risk of immunogenicity for both infliximab groups (Hazard Ratio [HR], 0.37; P <.0001) and for the adalimumab group ADL (HR, 0.34; P <.0001)

Overall, 140 patients (9%) withdrew from the study for serious adverse events. Five patients died, 3 from CD and 2 from possibly drug-related acute respiratory illness.

PANTS study investigator Tariq Ahmad, MRCP, DPhil, MB, ChB, head of the inflammatory bowel disease and pharmacogenetics research group at the University of Exeter, and Consultant Gastroenterologist at the Royal Devon and Exeter Hospital, United Kingdom, said in a statement, “We strongly believe that this type of research is essential to developing cost effective treatment strategies for patients with inflammatory bowel disease in order to maximize benefit. The results from PANTS suggest there are opportunities to optimize the management of anti-TNF therapies and to prevent treatment failure.”

“The PANTS results clearly show that the careful optimization of CT-P13, reference infliximab, and adalimumab as part of routine care may make these treatments more effective for patients with inflammatory bowel disease,” added Man Hoon Kim, president and CEO of Celltrion Healthcare, maker of the biosimilar infliximab, in a statement. Therefore, given the significant cost savings in using CT-P13, this treatment has the potential to play a huge role in increasing patient access to biological treatment and improving outcomes.”