Session Information
Date: Tuesday, November 10, 2015
Title: Rheumatoid Arthritis-Small Molecules, Biologics and Gene Therapy VI: Strategies
Session Type: ACR Concurrent Abstract Session
Session Time: 4:30PM-6:00PM
Background/Purpose: Recently published randomized
controlled trials (RCTs) have demonstrated similar outcomes in rheumatoid
arthritis (RA) patients treated with triple therapy [methotrexate (MTX),
sulfasalazine (SUL) and hydroxychloroquine (HCQ)] in comparison to patients
receiving MTX plus etanercept, a tumor necrosis factor inhibitor (TNFi).
Competing strategies examined in RCTs have included the addition of TNFi or
concomitant SUL/HCQ to MTX in patients experiencing suboptimal improvement in
MTX alone. This study aims to compare adherence and persistence rates
between combination treatments in US Veterans who added TNFi or concomitant
SUL/HCQ to MTX.
Methods: Veteran’s Affairs clinical and
administrative data from January 1, 2006 to December 31, 2012 was used for this
retrospective cohort study. Veterans with ICD-9-CM codes for RA transitioning
from MTX monotherapy to MTX-TNFi or triple therapy, the latter characterized by
simultaneous addition of HCQ/SUL, were examined for the 12-month period
following combination initiation. For the primary outcome, persistence required
that all drugs in each treatment be continued over the 12-month period without
a ≥90 day gap in refilling of any drug. Two alternative outcomes
were examined: 1) allowed discontinuation of any one DMARD in triple therapy or
MTX in the MTX-TNFi group, provided no new DMARDs were initiated or 2)
permitted switching between drugs within the TNFi class and non-biologic DMARD.
Adherence was calculated using proportion of days covered (PDC), defined as PDC
≥ 80% at 12 months.
Results: The MTX-TNFi patients (n=2,125) had higher
adherence and persistence compared to triple therapy patients (n=171)
(p<0.001 for all outcomes). The primary persistence outcome demonstrated
that 45% were persistent on MTX-TNFi and 18% were persistent on triple therapy
(p<0.001) (Figure, Table). 12 month adherence (PDC) was higher for the
MTX-TNFi group (26%) than the triple therapy group (11%). While the relatively
small sample size of the triple therapy group made controlling for all
potential confounders difficult, adjustment for observed covariates did not
significantly alter persistence and adherence.
Conclusion: Real-world persistence and adherence in
VA patients were higher in RA patients receiving MTX-TNFi therapy compared to
triple therapy. Findings were robust to varying outcome definitions and
controlling for potential confounders. While potential effects of channeling
bias cannot be excluded, these findings suggest that the patterns and benefits
of use of triple therapy in clinical practice may be different than that seen
in RCTs.
To cite this abstract in AMA style:
Erhardt D, Sauer B, Teng CC, Mikuls TR, Curtis JR, Tang D, Stolshek BS, Cannon GW. Clinical Practice Experience in Rheumatoid Arthritis Patients Treated with Triple Therapy and Methotrexate-Tumor Necrosis Factor Inhibition Differs from That of Randomized Controlled Trials [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/clinical-practice-experience-in-rheumatoid-arthritis-patients-treated-with-triple-therapy-and-methotrexate-tumor-necrosis-factor-inhibition-differs-from-that-of-randomized-controlled-trials/. Accessed .« Back to 2015 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/clinical-practice-experience-in-rheumatoid-arthritis-patients-treated-with-triple-therapy-and-methotrexate-tumor-necrosis-factor-inhibition-differs-from-that-of-randomized-controlled-trials/