AT DDW

CHICAGO (FRONTLINE MEDICAL NEWS) – The biosimilar infliximab CT-P13 is not inferior to the originator infliximab in terms of efficacy, safety, and immunogenicity in the treatment of inflammatory bowel disease (IBD), a phase IV randomized trial showed.

Patient outcomes were not compromised with the use of the biosimilar, and the cost of treatment was much lower, said lead author Kristin K. Jørgensen, MD, PhD, at Digestive Disease Week®.

“Biologics represent a substantial source of IBD expenditure,” said Dr. Jørgensen of Akershus University Hospital, Lørenskog, Norway. “The medication is expensive, patients are treated on a long-term basis, and the incidence of IBD is increasing.”

Biosimilars are biotherapeutic products that are similar in terms of quality, safety, and efficacy to the already licensed reference biologic product. “Use of biosimilars can potentially dramatically decrease costs and may lead to better patient care,” said Dr. Jørgensen. “The patient gets increased access to biologic therapy, and it is easier to intensify dosing if indicated.”

Tumor necrosis factor–inhibitors are commonly used to treat Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, and chronic plaque psoriasis, and, while they have altered the treatment paradigm, they are expensive products.

The goal of the NOR-SWITCH was to evaluate switching from originator infliximab to CT-P13, in terms of efficacy, safety, and immunogenicity.

Dr. Jørgensen and her colleagues conducted a randomized phase IV trial that enrolled 482 patients who were randomly assigned to either infliximab originator (n = 241) or CT-P13 (n = 241). The primary endpoint was disease worsening during follow-up.

Of the group, 155 patients (32%) had Crohn’s disease, 93 (19%) had ulcerative colitis, 91 (19%) had spondyloarthritis, 77 (16%) had rheumatoid arthritis, 30 (6%) had psoriatic arthritis, and 35 (7%) had chronic plaque psoriasis.

Disease worsening occurred at a similar rate in both groups. In the infliximab originator group, 53 patients (26%) experienced a worsening of their symptoms, compared with 61 patients (30%) in the CT-P13 group. The 95% confidence interval of the adjusted risk difference (−4.4%) was −12.7% to 3.9%, which fell within the prespecified noninferiority margin of 15%.

Therefore, the findings demonstrated that CT-P13 is not inferior to infliximab originator, and the adjusted relative risk of disease worsening for CT-P13 patients was 1.17 (95% CI, 0.82-1.52), compared with the infliximab originator group.

An almost equal number of patients achieved disease remission, 123 patients (61%) in the infliximab originator group and 126 patients (61%) in the CT-P13 group, and the adjusted rate difference was 0.6% (95% CI, –7.5%-8.8%; per-protocol set).

An explorative subgroup analysis that looked at patients with Crohn’s disease and ulcerative colitis showed similar findings between patients treated with either agent.

“Our results support switching from the originator to a biosimilar for nonmedical reasons,” concluded Dr. Jørgensen.

However, she urged caution in generalizing these findings to other biologic agents.

The study was funded by the Norwegian Ministry of Health and Care Services. Dr. Jorgensen reported receiving personal fees from Tillotts, Intercept, and Celltrion. Several coauthors also reported relationships with industry.

Digestive Disease Week® is jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE), and the Society for Surgery of the Alimentary Tract (SSAT).

ginews@gastro.org

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