Sustained Remission Shown In Ankylosing Spondylitis In Those Switched From Reference Infliximab To Its Biosimilar

July 2019

A recent Greek cohort study reported that Ankylosing Spondylitis (AS) patients in remission remained in remission after switching from the originator biologic, reference infliximab (Remicade®) to the biosimilar infliximab, (Inflectra®, Remsima®). The 18-month long, open label, observational study found no difference in disease activity, efficacy, or safety in those switched to the biosimilar medication.

Methodology:

Among 88 total participants – all being AS patients in clinical remission for approximately three years – 45 (test group) were switched from reference infliximab (Remicade®) to biosimilar infliximab (Inflectra®, Remsima®), while 43 (control group) continued receiving the originator biologic. Disease activity was measured using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)¹, and the Ankylosing Spondylitis Disease Activity Score using the C-reactive protein (ASDAS-CRP)², both being evaluation tools in which patients rate their symptom severity on a 1-10 scale. The researchers tracked all participants for 18 months, then compared the findings from the two groups.

Results:

During the follow up period, five patients from the test group and three from the control group withdrew from the study. At the end of the 18-month study all remaining participants in both groups remained in clinical remission, with low BASDAI, low ASDAS, and low inflammatory markers in the blood (low ESR and CRP scores.)

The authors concluded that the biosimilar infliximab was found equivalent to the originator, reference infliximab in sustaining clinical remission in AS. They note that long-term data is missing, and as such long-term effects have not yet been studied.

Full study can be found here: MDPI

Read more about biosimilars in SAA’s Spondylitis Plus magazine – Biosimilars

[1] The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is an established self-administered diagnostic test which allows a physician to determine the effectiveness of a current drug therapy by measuring severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness. Scores range from 0 (best) to 10 (worst); a score >4 indicates active disease.

[2] The Ankylosing Spondylitis Disease Activity Score (ASDAS) is used to assess disease activity in the participants, which is defined as a decrease of at least two points from baseline (ASDAS-MI: ≥2.0) or lowest possible score (0.6).

References:

• • Kaltsonoudis, Evripidis, et al. “Maintained Clinical Remission in Ankylosing Spondylitis Patients Switched from Reference Infliximab to Its Biosimilar: An 18-Month Comparative Open-Label Study.” MDPI, Multidisciplinary Digital Publishing Institute, 2 July 2019, www.mdpi.com/2077-0383/8/7/956.
  • “In a Single-Center Study, Patients With AS Remained in Remission After a Switch to CT-P13.” Center for Biosimilars, The Center for Biosimilars Staff, 14 July 2019, www.centerforbiosimilars.com/news/in-a-singlecenter-study-patients-with-as-remained-in-remission-after-a-switch-to-ctp13.