Reasons for Discontinuation and Adverse Effects of TNFα Inhibitors in a Cohort of Patients With Rheumatoid Arthritis and Ankylosing Spondylitis

2016 ◽  
Vol 51 (5) ◽  
pp. 388-393 ◽  
Author(s):  
María Henar García-Lagunar ◽  
María Rocío Gutiérrez-Cívicos ◽  
María Sergia García-Simón ◽  
Pablo Conesa-Zamora ◽  
Enrique Jimenez-Santos ◽  
...  

Background: The introduction of anti–tumor necrosis factor α (anti-TNFα) drugs has improved the clinical outcomes in rheumatoid arthritis (RA) and ankylosing spondylitis (AS). However, these drugs may cause adverse effects that motivate a change in or discontinuation of the treatment. Objective: To evaluate the causes of discontinuation or changes in the dosage regimen in a cohort of patients with RA and AS treated with infliximab, adalimumab, etanercept, and golimumab under clinical practice conditions. Methods: This was a retrospective observational study that included patients with RA or AS treated with anti-TNFα drugs between 2008 and 2013. Changes in the dosage regimen, reasons for treatment discontinuation, and adverse effects were recorded and analyzed. Time to discontinuation was estimated using Kaplan-Meier survival analysis. Results: A total of 123 patients with RA and 93 patients with AS were treated with anti-TNFα therapy. During the study, 55.3% of RA patients and 41.7% of AS patients had stopped the treatment. The most frequent changes were modifications in the dosing, and the most frequent adverse effects were reactions after the infusion or injection (53.8% and 66.7% in RA and AS, respectively). Drug survival of etanercept in RA (67.9%) is greater than for adalimumab and infliximab, whereas drug survival of infliximab in AS (70.0%) is greater than for etanercept and adalimumab at 5 years, although there were no significant differences ( P = 0.098 in RA and 0.194 in AS). Conclusions: The main cause of discontinuation of anti-TNFα is therapeutic failure in both diseases. Etanercept and infliximab have the best survival rates in RA and AS, respectively.

2017 ◽  
Vol 9 (8) ◽  
pp. 197-210 ◽  
Author(s):  
Valeria Rios Rodriguez ◽  
Denis Poddubnyy

Nonradiographic axial spondyloarthritis (SpA) and radiographic SpA (also known as ankylosing spondylitis) are currently considered as two stages or forms of one disease (axial SpA). The treatment with tumor necrosis factor-α (TNFα) inhibitors has been authorized for years for ankylosing spondylitis. In recent years, most of the anti-TNFα agents have also been approved for the treatment of nonradiographic axial SpA by the European Medicines Agency (EMA) and similar authorities in many countries around the world (but not in the US), increasing the number of possible therapies for this indication. Data from several clinical trials have demonstrated the good efficacy and safety profiles from those anti-TNFα agents. Presently, a large number of patients achieve a satisfactory clinical control with the current therapies, however, there remains a percentage refractory to nonsteroidal anti-inflammatory drugs (NSAIDs) and TNFα inhibitors; therefore, several new drugs are currently under investigation. In 2015, the first representative of a new class of biologics [an interleukin (IL)-17 inhibitor] secukinumab, was approved for the treatment of ankylosing spondylitis; a clinical trial in nonradiographic axial SpA is currently underway. In this review, we discuss the recent data on efficacy and safety of TNFα-inhibitors focusing on the treatment of nonradiographic axial SpA.


2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1122.1-1122
Author(s):  
M. Nguyen ◽  
K. Velthuis ◽  
J. Scholl ◽  
J. Jansen ◽  
L. Kosse ◽  
...  

Background:Treatment of rheumatoid arthritis (RA) with biologic disease-modifying antirheumatic drugs (bDMARDs) has been common practice in the last two decades. However, differences in patients experiencing adverse drug reactions (ADRs) between individual bDMARDs, such as adalimumab (ADA) and etanercept (ETN), during first time treatment has not been studied yet in real-world settings.Objectives:To compare proportions of RA patients experiencing ADRs as well as survival to first ADR and drug survival during treatment with ADA and ETN.Methods:Retrospective single centre cohort study including adult patients with RA, treated with either ADA or ETN between 1 January 2003 and 30 April 2020. The proportions of patients experiencing an ADR were compared by assessing the percentage of patients, treated with either ADA or ETN, experiencing at least one ADR during their first time treatment. Survival to first ADR and drug survival were assessed by calculating time between start of treatment and first ADR and start of treatment and discontinuation of treatment respectively. Stop and restart of treatment within 90 days was considered as continuous use. Differences in proportions were statistically tested using Fisher’s Exact Test. Differences in drug survival between ADA and ETN were tested by Kaplan-Meier analysis and Log Rank tests.Results:A total of 422 patients were included in this study (ADA 259, ETN 163). For 93 patients (21.2%) an ADR was registered during first time treatment. The proportion of patients experiencing at least one ADR during their first time treatment was 22.7% for ADA and 20.2% for ETN (p=0.628). Survival time to first ADR did not differ significantly between ADA and ETN (median survival ADA 10.34 years (95% CI [7.62-13.06], median survival ETN not reached, p=0.109, figure 1A). Median drug survival was 1.75 years for ADA (95 CI [1.38-2.11]) and 2.68 years for ETN (95% CI [1.73-3.64]). Drug survival differed significantly (p<0.001, figure 1B).Figure 1.Kaplan-Meier survival curves for adalimumab and etanercept with (a) survival to first ADR and (b) drug survival.Conclusion:Neither the proportion of patients experiencing ADRs nor survival to first ADR during first time treatment with ADA and ETN differed significantly. Drug survival of first time drug treatment of ADA was significantly lower compared to drug survival of first time drug treatment of ETN.Disclosure of Interests:My Nguyen: None declared, Kimberly Velthuis: None declared, Joep Scholl: None declared, Jurriaan Jansen: None declared, Leanne Kosse: None declared, Peter ten Klooster: None declared, Naomi Jessurun: None declared, Harald Vonkeman Consultant of: BMS, Celgene, Celltrion, Galapagos, Gilead, Janssen-Cilag, Lilly, Novartis, Pfizer, Sanofi-Genzyme, Grant/research support from: Abbvie


2015 ◽  
Vol 42 (12) ◽  
pp. 2376-2382 ◽  
Author(s):  
Justine Corli ◽  
René-Marc Flipo ◽  
Peggy Philippe ◽  
Anne Bera-Louville ◽  
Hélène Béhal ◽  
...  

Objective.The purpose of this study was to (1) evaluate baseline characteristics of nonradiographic axial spondyloarthritis (nr-axSpA) and ankylosing spondylitis (AS) treated with tumor necrosis factor-α inhibitors (TNFi), (2) assess the response to first TNFi treatment, and (3) compare drug-survival duration and rates.Methods.Inclusion criteria were patients with axSpA who initiated first TNFi treatment between April 2001 and July 2014 and were followed up for at least 3 months. Efficacy criteria were an improvement of at least 2 points (on a 0–10 scale) or a 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Baseline characteristics, responses at 12 months, and drug survival were compared between AS and nr-axSpA.Results.A total of 361 patients were included in the study (AS, n = 263 and nr-axSpA, n = 98). Patients with AS were more often men (65.02% vs 45.92%, p = 0.001) and had longer symptom duration (11.71 ± 9.52 vs 7.34 ± 9.30 yrs, p < 0.001). Median levels of acute-phase reactants (C-reactive protein and erythrocyte sedimentation rate) were significantly higher in patients with AS (p < 0.001 for both). Median BASDAI scores at first TNFi initiation were not higher in patients with nr-axSpA than in patients with AS (59, 49–70 vs 60, 50–70, p = 0.73). BASDAI 20 and BASDAI 50 response rates at 12 months were not statistically different between patients with AS and patients with nr-axSpA (74.58% vs 64.58%, p = 0.19 and 61.02% vs 50.00%, p = 0.19, respectively). No statistically significant difference in terms of survival was observed between patients with AS and nr-axSpA (p = 1.00).Conclusion.Treatment response and drug survival were similar in patients with AS and nr-axSpA after first TNFi initiation.


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