In a Single-Center Study, Patients With AS Remained in Remission After a Switch to CT-P13

As more health systems seek to make use of the cost savings associated with biosimilars, data continue to accrue to support switching patients to these products. One recent paper, published in The Journal of Clinical Medicine, reported that, after a switch from reference infliximab to biosimilar CT-P13 (Inflectra, Remsima), patients with ankylosing spondylitis (AS) who switched to the biosimilar remained in remission at 18 months post-switch.

The study, conducted at a single center in Greece, included 88 infliximab-treated patients with AS who were in clinical remission. All patients were naïve to previous biologics before starting infliximab, and all were provided with education about the switch. In total, 45 patients were switched to the biosimilar, while 43 patients continued to receive the reference infliximab. Clinical, laboratory, and demographic parameters were similar between the 2 groups.

At the end of the 18 months of follow-up, write the investigators, all patients in both groups remained in clinical remission as determined by the Bath Ankylosing Spondylitis Activity Index and the Ankylosing Spondylitis Activity Score using C-reactive protein, and no significant adverse events or comorbidities were observed in either group.

In total, 4 patients who had switched to the biosimilar reported what the investigators call “subjective complaints,” including somnolence and headache. These patients were deemed to have nocebo effects and were switched back to the reference, and 1 was switched to a different agent, all with good results. In the reference group, 2 patients had respiratory tract infections and 1 patient experience a disease flare. These patients were also switched to a different agent and had good results.

“Our findings are in line with the PLANETAS study despite the fact that they used different tools in assessing disease activity,” write the authors, who add that the success of the switch may be linked with patient education and its ability to reduce the nocebo effect.

While the study is limited by the small number of patients, it offers, according to the authors, the longest comparative data on a switch to biosimilar infliximab in patients with AS.

Reference

Kaltsonoudis, Pelechas E, Voulgari PV, Drososo AA. Maintained clinical remission in ankylosing spondylitis patients switched from reference infliximab to its biosimilar: an 18-month comparative open-label study [published online July 2, 2019]. J Clin Med.