Background/Purpose: The combination of methotrexate (MTX), hydroxychloroquine (HCQ) and sulfasalazine (SSZ) has been called Triple Therapy (Triple) and has been compared with a combination of TNF inhibitors and MTX (TNFi + MTX). We sought to examine the use of Triple in a large US registry and compare the clinical and sociodemographic characteristics of the patients starting either therapy to determine if there were clinically relevant differences at initiation.

Methods: All eligible initiations in the Corrona registry from 2001-2017 were considered. Initiation of Triple was defined as initiation of one or more of the three drugs resulting in the first time use of all three drugs. Initiation of TNFi+MTX was defined as the initiation of TNFi resulting in the first time use of TNFi + MTX. Initiations were in patients who were biologic/small molecule naïve. Sociodemographic, clinical and disease characteristics were compared at time of initiation between the therapies. Patients initiating Triple who later initiated TNFi+MTX were not included in the TNFi+MTX cohort. Standardized mean differences (SMDs) were used to compare patients initiating Triple vs TNFi+MTX therapy; |SMDs| >0.15 were considered clinically relevant.

Results: From 2001- 2017, we identified 3452 TNFi+MTX and 226 Triple eligible initiations. Table 1 describes patient characteristics with |SMDs|>0.15. Triple initiators were older, had longer disease duration, were more likely to have Medicare coverage, and more likely to be RF+ or CCP+. Triple initiators had a history of more comorbidities than TNFi+MTX initiators. TNFi +MTX initiators had higher disease activity measures than Triple initiators: CDAI and all its components, patient fatigue and mHAQ. There were larger differences in MD Global and joint counts (|SMDs|>0.30) than Pt Global and Pt Fatigue (|SMDs| < 0.19) At start of therapy patient pain and prednisone, analgesic and NSAID use were not different (|SMDs| <0.15).

Conclusion: Utilization of Triple was not common over a period of 16 years covered by the registry. Pts started on triple were older, had less severe RA and a higher comorbidity burden. These differences are likely to impact response to treatment as it appears that rheumatologists channeled pts with more severe RA to TNFi + MTX, while pts with a h/o comorbidities were more likely to receive Triple.

Table 1. Clinically relevant standardized differences (SMDs) between groups, all initiators

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/clinical-and-sociodemographic-characteristics-of-patients-with-rheumatoid-arthritis-ra-starting-triple-therapy-and-a-combination-of-a-tnf-inhibitor-and-methotrexate-from-a-large-us-registry/