Background/Purpose: The order of use of biologic agents after failing a TNF inhibitor is still a question for debate. Phase III trial data in TNF-IR patients show comparable efficacy results across biologic agents and limited head-to-head studies have been published. Prospective registries offer a unique opportunity to observe the effectiveness (combined evaluation of efficacy and safety profile over time) of these agents in a real world clinical setting where all patients with a specific diagnosis and treated in the center are included. We report here a sixth year follow-up analysis. Our aim is to evaluate if patients with rheumatoid arthritis (RA) treated with rituximab (RIT) after failing a first or a second anti-TNF agents (TNF-IR) have different six-year  retention rate than patients similarly prescribed anti-TNF agents (pooled adalimumab, etanercept or infliximab) and compare the treatment strategies of using RIT as second or third biologic treatment .

Methods: Data from TNF-IR RA patients prescribed adalimumab (ADA), etanercept (ETA), infliximab (INF) or rituximab (RIT) as second or third biologic agents on or after January 1^st2007 was extracted and subjects taking either ADA, ETA or INF were pooled to form the anti-TNF cohort. Baseline demographics included age, disease duration, HAQ-DI, fatigue and pain visual analog scale evaluations (VAS), TJC, SJC, DAS 28 ESR and SDAI. Six-year drug retention rates were estimated and compared using Kaplan-Meier survival estimates. Statistical analysis was performed using SAS version 9.3. RHUMADATA® is a clinical database and registry used in daily clinical practice at the IRRM and CORQ. All patients with RA are followed over time irrespective of their treatment.

Results: The data from 231 RA patients were extracted, 155 and 76 having respectively failed a first and a second anti-TNF agent. No clinically significant differences in baseline variables were observed between treatment groups in second and third intention. The 6 year retention rates of second line RIT and anti-TNF use were 80.1% and 19.1% respectively (Log-rank p< 0.0001). In patients having failed two anti-TNF, subsequent use of RIT and anti-TNF agents respectively demonstrated 6 year retention rates of 53.6% and 37.2% (Log-rank p=0.0473).  Second versus third line use was numerically (80.1% vs 53.6%)   and statistically superior (Log-rank p=0.0029). 

Conclusion:

As second and third line agent, in TNF-IR RA patients, RIT demonstrates a better 6 year retention rate than anti-TNF agents. Second line use demonstrated a statistically better retention rate than third line use. This suggest that using rituximab as a second agent after failing a first  anti-TNF agent is a better strategy than waiting to use it after two different anti-TNF failure.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/use-of-rituximab-compared-to-anti-tnf-agents-as-second-and-third-line-therapy-in-patients-with-rheumatoid-arthritis-6-year-follow-up-report-from-the-rhumadata-clinical-database-and-registry/