Date: Sunday, November 5, 2017
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: More than 4 years have passed since 7 biologics became available for patients with rheumatoid arthritis (RA) in Japan, still lack reliable evidence in their differences of tolerability and discontinuation reasons.
Methods: A total of 1,037 biologics treatment courses of RA from 2009 to 2016 [female 81.8%, baseline age 59.6 y, disease duration 7.8y, bio continued duration 17.1 months, RF positivity 81.5%, ACPA positivity 86.7%, DAS28-ESR 4.4, CDAI 16.8, HAQ 1.1, Bio naïve 57.1% and switched 42.9%, methotrexate (MTX) 5.9 mg/week (limited to 16mg/week in Japan) (68.6%), prednisolone (PSL) 2.5 mg/day (43.5%), abatacept (ABT) 21.3%, tocilizumab (TCZ) 20.7%, golimumab (GLM) 16.9%, etanercept (ETN) 13.6%, adalimumab (ADA) 11.1%, infliximab (IFX) 8.5%, certolizumab pegol (CZP) 7.9%] were included in this 7-center, retrospective study. The drug tolerability and discontinuation reasons at 36 months were estimated using Kaplan-Meier method, and adjusted by potent confounders [Sex / Age / Bio started date / Disease duration / ACPA positivity / RF positivity / bio naive or switched / combined csDMARDs (MTX, tacrolimus, bucillamine, salazosulfapyridine, iguratimod) and PSL / baseline DAS28-ESR / HAQ] which may affect biologics retention rates using a Cox proportional hazards model.
Results: There were no significant differences in the baseline disease activity (DAS28-ESR and CDAI). The major causes of 7 biologics treatment discontinuation were as follows. Drug inefficacy (47.7%), other nontoxic reasons (12.3%), remission (8.6%), infection (7.5%), patients’ preference (7.5%), other adverse events such as malignant, cardiovascular, pulmonary, renal, hematologic complications (6.2%), skin or systemic reaction (5.3%), and changing hospital (5.1%). Adjusted discontinuation reasons and ratio at 36 months in each drug were as follows. Drug inefficacy (TCZ 16.1%, ABT 23.7%, ETN 28.4%, CZP 32.9%, IFX 33.3%, ADA 42.3%, and GLM 46.1%; P=0.14), remission (IFX 11.4%, ADA 2.6%, ETN 1.4%, ABT 0.5%, TCZ 0.5%, GLM 0.0%, and CZP 0.0%; P<0.001), infection (ABT 1.4%, TCZ 1.5%, GLM 2.0%, ETN 2.3%, ADA 2.5%, IFX 4.0%, and CZP 5.5%; P=0.77), other adverse events (ABT 1.2%, ETN 2.0%, CZP 4.9%, GLM 5.6%, ADA 7.2%, TCZ 8.5%, and IFX 11.7%; P=0.03), and skin or systemic reaction (ABT 0.0%, TCZ 0.5%, GLM 1.1%, ADA 1.7%, ETN 2.1%, CZP 3.7%, and IFX 4.5%; P=0.02), respectively. Adjusted total retention rates at 36 months were as follows. TCZ 58.9%, ABT 55.1%, CZP 51.4%, ETN 50.2%, GLM 37.6%, ADA 32.7%, and IFX 21.7% (P=0.006).
Conclusion: When adjusted by potent confounders, TCZ showed lowest inefficacy and highest retention rate, ABT showed lowest infection, skin or systemic reaction, or other toxic adverse events rate, and IFX showed highest remission discontinuation rate at 36 months compared to other biologics in RA.
To cite this abstract in AMA style:Ebina K, Hirao M, Hashimoto M, Furu M, Yamamoto W, Hara R, Fujimura T, Hirano T, Yoshida S, Nagai K, Amuro H, Son Y, Onishi A, Akashi K, Katayama M, Yamamoto K, Yoshikawa H. Comparison of Drug Tolerability and Discontinuation Reasons between 7 Biologics in Patients with Rheumatoid Arthritis -Results from Kansai Consortium for Well-Being of Rheumatic Disease Patients (ANSWER cohort)- [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/comparison-of-drug-tolerability-and-discontinuation-reasons-between-7-biologics-in-patients-with-rheumatoid-arthritis-results-from-kansai-consortium-for-well-being-of-rheumatic-disease-patients-answ/. Accessed October 22, 2019.
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