Effectiveness and persistence of golimumab as a second biological drug in patients with spondyloarthritis

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.

Effectiveness of Golimumab as Second Anti-TNFα Drug in Patients with Rheumatoid Arthritis, Psoriatic Arthritis and Axial Spondyloarthritis in Italy: GO-BEYOND, a Prospective Real-World Observational Study

“…This real-life prospective study specifically focused on the effectiveness of GLM in a subgroup of patients who are not normally included in clinical trials, and our findings reveal that in patients with spondyloarthropathies (axSpA and PsA) as well as RA, who need to discontinue their first anti-TNF drug, the decision to switch to GLM can be considered a suitable therapeutic choice. These findings are in agreement with results reported in other recent real-life studies [ 21 , 22 , 23 , 24 , 25 , 26 ].…”

“…However, in patients with PsA or axSpA, data on the effectiveness of GLM following the first-line anti-TNF failure are scarce [ 19 , 20 ]. To address this gap, recent real-life retrospective studies performed in Spain [ 21 ], Turkey [ 22 ], France [ 23 , 24 ], Germany [ 25 ] and Italy [ 26 ] have examined the long-term effectiveness and retention rate of GLM. The present prospective study, GO-BEYOND, was designed to evaluate the effectiveness of GLM as a second anti-TNF drug in patients with RA, axSpA or PsA who discontinued a first anti-TNF drug.…”

Long-term effectiveness and drug survival of golimumab in patients affected by psoriatic arthritis with cutaneous involvement

“…The drug survival of GLM was independent of the line of treatment used and the previous use of bDMARDs and can be considered effective both as first-line therapy and in patients with failure for one or more bDMARDs. Data from international and national registries, such as the GISEA registry or the BioRx.si, have compared the characteristics of patients starting treatment with GLM [ 11 , 18 , 19 ]. bDMARD-naïve and bDMARD-experienced patients were compared and no difference in the persistence of GLM was found.…”

“…The switch among the same group of drugs, as the TNFi family, is still a debate in PsA management and patients failing a first TNFi agent usually use a different target [ 11 ]. However, several data from the literature seem to support the efficacy of switching among TNFi in PsA [ 10 , 19 ]. The evaluation of drug persistence in our real-life experience demonstrated a good percentage (54%) of patients still on therapy after 4 years of GLM treatment.…”

“…Recently, none of the TNFi agents was found to be more persistent than others as first-line therapy, while secukinumab was found to be superior to other biologics when indicated as second-line therapy [ 23 ]. However, data from Slovenia showed a better persistence of GLM compared to other TNFis in bDMARD-experienced AS and PsA patients [ 19 ].…”