Background/Purpose: After more than a decade of biological agents (BA) use for the treatment of rheumatoid arthritis (RA), it is necessary a thorough knowledge of their long-term use in real life conditions, with a special emphasis in the causes leading to treatment discontinuation, in order to improve and optimize the prescription and withdrawal of these medications.  To evaluate the survival of BA and the causes of discontinuation in a cohort of patients diagnosed with RA.

Methods: We performed an observational retrospective longitudinal study from January 1^st, 2000, until December 18^th, 2012. We included subjects followed up in our outpatient clinic, diagnosed with RA, whom started treatment with a BA [etanercept (ETN), golimumab (GOLI), certolizumab (CTZ), infliximab (IFX), adalimumab (ADA), rituximab (RTX), abatacept (ABA), or tozilizumab (TZL)]. Our primary endpoint was BA discontinuation due to: a) adverse drug reaction (ADR) (including those that required hospital admission and those that resulted in patient death), b) inefficacy c) patient decision d) remission or improvement, e) other causes. Kaplan Meier curves were set to account for all drugs discontinuation. To estimate the incidence of BA suspension we used survival techniques, expressing the incidence rate (IR) per 100 patients-year with their respective 95% confidence interval (95% CI).

Results: 405 patients were included in the study, whom began 744 different courses of BA treatment, with a total follow up time of 1,612 patients-year. Of these, 81% were women with a mean age [standard deviation (SD)] at diagnosis of 52.5 (13) years and the mean time (SD) to the first BA of 5 (4.8) years. The drug most frequently used was ADA (32%), followed by ETN (25%), IFX (20.7%), RTX (13.5%), ABA (4.3%), CTZ (1.8%), TZL (1, 6%), and GOLI (1.1%). 61.3% of the BA were discontinued during the follow-up (456 suspensions in 248 patients): 45% due to inefficacy, 43.4% to ADR (including 17% of those that required hospital admission and 1.3% deaths) and 11.6% other (3.5% improvement, 5.4% patient decision and 2.7 due to other medical decision). In the first year of therapy 68% of the patients continued on BA, and the mean survival time was 2 years (95%CI 1.6-2.3). The IR of discontinuation, regardless the cause, was 28.3 per 100 patient-years (95% CI: 25-31). The IRs depending on the causes of withdrawal were 12.6 (95%CI 11.0-14.5; inefficacy); 12.3 (95%CI 10.7-14.1; all ADR); 4.8 (95%CI 3.8-6.0; severe ADR); 0.6 (95%CI 0.3-1.1; death); 0.9 (95%CI 0.6-1.6; improvement); and 1.5 (95%CI 0.9-2.2; patient decision).

Conclusion: The IR for BA suspension in RA patients was 28 per 100 patients-year, being the most common cause inefficiency, and ADR. This study contributes to increasing knowledge of the long-term survival of these drugs in real life.

 

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/survival-of-biological-therapy-in-rheumatoid-arthritis-12-years-follow-up-cohort/