Study Finds Strong Retention at 4 Years for Patients With AS Treated With CT-P13

Data continue to accrue on the use of biosimilar infliximab, CT-P13 (Inflectra, Remsima), in a variety of disease states, and a recent study among patients with ankylosing spondylitis (AS) who were treated with the biosimilar demonstrated infrequent discontinuation of therapy.

The study relied on the Korean College of Rheumatology biologics registry, or KOBIO, a prospective, observational registry that gathers data on patients with inflammatory diseases who are treated with biologics. Researchers assessed data from 224 patients with AS who were treated with CT-P13 and enrolled in the registry between 2012 and 2017. In total, 83.2% of these patients received the biosimilar as a first-line therapy.

Overall, disease activity decreased markedly from baseline and remained stable during follow-up. In total, 56.5% and 82.2% of patients had major or clinically important improvement, respectively, as measured by Ankylosing Spondylitis Disease Activity Score.

Data on retention were available for 208 of the patients (173 of whom were receiving the biosimilar as a first-line treatment). Overall retention at 4 years was 66%. The overall median duration of CT-P13 treatment was 2.05 years (range, 0.04-4.18). The median treatment duration in patients receiving first-line treatment was 2.09 years (range, 0.04-4.18), versus 1.11 years (range, 0.04-4.01) in patients for whom the biosimilar was a subsequent line of therapy.

Overall, 15.6% of patients switched from CT-P13 to a different therapy (most frequently to golimumab or adalimumab), and 13.1% discontinued all biologic treatment. Lack of efficacy was cited by 13.9% of patients as a reason for a change to treatment, while a total of 5 patients, all of whom were receiving first-line CT-P13, cited clinical remission as a reason for discontinuation.

Overall, 48.4% of patients reported 313 adverse events (AEs). In total, 72 of these AEs were considered to be related to CT-P13 treatment. The most common AEs that resulted in changes to treatment were infusion-site reactions, skin rash, and uveitis.

According to the authors, the 4-year follow-up in this analysis offers important insight into treatment with CT-P13, and that “CT-P13 demonstrated encouraging drug retention rates and retention times, as well as reasonable long-term efficacy and safety.”

Reference

Kim HA, Lee E, Lee SK, et al. Retention rate and long-term safety of biosimilar CT-P13 in patients with ankylosing spondylitis: data from the Korean College of Rheumatology biologics registry [published online July 19, 2019]. Clin Exp Rheumatol. clinexprheumatol.org/article.asp?a=13765.