Study Finds that CT-P13 May Be Effective in Takayasu Arteritis

Researchers recently sought to evaluate the efficacy and safety of infliximab biosimilar CT-P13 in the treatment of Takayasu arteritis (TAK), a granulomatous inflammatory vasculitis that affects the aorta and can cause aneurysms to form. Some patients with TAK benefit from corticosteroids or second-line, small-molecule immunosuppressive agents, but there is a demand for more effective therapeutic options.

Investigators designed a single-center, prospective, open-label study that enrolled 12 patients with TAK who received the infliximab biosimilar. One patient was excluded for analysis due to a protocol violation. All participants were female with a mean age of 46.8 years. The trial enrolled patients who had taken a daily dose of 10 mg of prednisolone (or its equivalent), and the dose was maintained for at least 2 weeks prior to the initiation of treatment with CT-P13 and throughout the study.

Patients received intravenous infusions of biosimilar infliximab at a starting dose of 5 mg/kg at weeks 0, 2, and 6, and then every 8 weeks up to week 46. Patients whose erythrocyte sedimentation rate (ESR) had not improved by 50% or more at week 14 were required to increase the dose of CT-P13 by 1.5 mg/kg. Patients were followed to week 54.

The primary endpoint was the achievement of either partial or complete remission by week 30, and secondary endpoints included changes in modified Indian Takayasu Clinical Activity Score (ITAS-A) and serum levels of acute phase reactants at week 30 from baseline.

At week 30, 3 (27.3%) of the 11 patients treated with CT-P13 achieved complete remission, while 6 (54.5%) patients achieved partial remission. Researchers noted that the therapy failed in 2 patients.

Both sustained clinical and serologic response was seen in 4 (44.4%) of the patients who initially achieved either complete or partial remission. The other 3 patients (33.3%) included in the study maintained clinical response but had abnormalities of acute phase reactants, wrote the study authors.

The researchers found that, during the treatment period, no adverse events (AEs) or serious AEs occurred that would call for a discontinuation of treatment. In general, minor infection events were the most frequently reported adverse event, including upper respiratory tract infection and viral keratitis.

Though the trial had a relatively small number of patients, and no definitive conclusions could be drawn regarding the efficacy of infliximab for the treatment of TAK, the researchers said that the findings set a basis for future studies. “This prospective open-label trial of…CT-P13 suggests that CT-P13 therapy may lead to remission or improvement with lower glucocorticoid requirement in TAK. Randomized controlled studies are warranted to assess the long-term efficacy and safety of infliximab and propose precise treatment guidelines for infliximab in TAK,” wrote the investigators.

Reference

Hye Park E, Young Lee E, Jong Lee Y, et al. Infliximab biosimilar CT-P13 therapy in patients with Takayasu arteritis with low dose of glucocorticoids: a prospective single-arm study. Rheumatol Int. 2018; 38(12): 2233-2242. ncbi.nlm.nih.gov/pmc/articles/PMC6223861/. Accessed January 17, 2018.