Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product.
OBJECTIVE
To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center.


METHODS
In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval.


RESULTS
Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9), mean disease duration 14.79 years (9.7), median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3) months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively). There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7%) patients discontinued the biosimilar infliximab.


CONCLUSIONS
Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost.
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Abuelmagd
A
Abdalla
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Niamh
N
Byrne
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Richard
R
Conway
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Thomas
T
Walsh
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Geraldine
G
Mannion
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Michael
M
Hanly
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Miriam
M
O'Sullivan
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
Ann Maria
AM
Curran
Department of Rheumatology, Galway University Hospitals, Galway, Ireland.
John J
JJ
Carey
adult; biologic therapy; biosimilar exchange; infliximab; rheumatic diseases