Effectiveness and persistence of golimumab as a second biological drug in patients with spondyloarthritis: A retrospective study.

Abstract: This observational, longitudinal retrospective, noncomparative study was designed to assess the persistence and effectiveness of golimumab as a second anti-tumor necrosis factor (TNF) drug in patients with spondyloarthritis requiring discontinuation from a first anti-TNF drug.Data were collected retrospectively for all patients with axial spondyloarthritis or psoriatic arthritis from 20 rheumatology clinics in Spain who started golimumab as a second anti-TNF drug between January 2013 and December 2015. Golimumab persistence was assessed with Kaplan-Meier survival analysis, and associated factors were assessed with Cox regression analysis.210 patients started golimumab as a second anti-TNF drug: 131 with axial spondyloarthritis and 79 with psoriatic arthritis. In axial spondyloarthritis patients, the mean (standard deviation) Bath Ankylosing Spondylitis Disease Activity Index score at baseline was 5.5 (2.1), decreasing to 3.9 (2.0) at month 3 and 3.5 (2.0) at year 1, and remaining stable thereafter. In psoriatic arthritis patients, mean (standard deviation) baseline Disease Activity Score was 4.0 (1.3), reducing to 2.5 (1.2) at month 3 and to 2.2 (1.3) at year 1. Corresponding improvements were recorded from baseline in C-reactive protein levels and erythrocyte sedimentation rates. The probability of persistence of treatment with golimumab was 80% at year 1, 70% at year 2 and 65% at years 3 and year 4, and was similar in those who had stopped the first anti-TNF due to loss of efficacy or other reasons. Cox regression analysis showed that the probability of survival with golimumab was higher in patients with higher erythrocyte sedimentation rate, in patients with axial spondyloarthritis than with psoriatic arthritis, and in those who had discontinued adalimumab as first anti-TNF. Seventy-two patients (34.3%) discontinued golimumab during follow-up, 50 of them due to lack of efficacy.In patients with spondyloarthritis requiring discontinuation from a first anti-TNF drug, treatment with golimumab was effective and showed a high probability of persistence up to 4 years of treatment.
Competing Interests: Conflict of interest: Juan J Alegre-Sancho: speaker for MSD; Xavier Juanola: no conflicts of interest; José M Rodríguez-Heredia: board membership for Janssen, Sandoz and Sanofi, and speaker for BMS, UCB, Pfizer, Janssen, Novartis and Celgene; Javier Manero: no conflicts of interest; Ignacio Villa-Blanco: no conflicts of interest; Ana Laiz: board membership for Janssen, Novartis and Celgene, and speaker for Lilly, MSD, Janssen, Novartis and Celgene; María J Arteaga: full-time employee of Merck Sharp & Dohme Spain; Luis Cea-Calvo: full-time employee of Merck Sharp & Dohme Spain; Carlos M González: consultancy for MSD, Gilead, Pfizer, Roche, Novartis and Janssen, speaker for Roche, Novartis and Celgene, and travel and accommodation costs for meetings from Janssen, Pfizer and Roche.
(Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.)