Session Information
Date: Sunday, November 5, 2017
Title: Rheumatoid Arthritis – Clinical Aspects Poster I: Treatment Patterns and Response
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Methotrexate (MTX) is recommended as part of initial therapy in early RA, but practices range widely. The objective of this analysis was to describe MTX treatment in an early RA cohort, beginning with initial therapy and assessing time to treatment failure across various treatment strategies.
Methods: We studied adult patients from a prospective multicenter early arthritis cohort (enrolled 2007-2017 within one year of symptom onset) who fulfilled ACR/EULAR RA criteria. RA patients were eligible for our analyses if they initiated MTX (+/-other DMARDs) within 90 days of cohort entry. The first analyses determined time until ‘failure’ of that initial MTX-based therapy, from the time of first initiation, left-censored at cohort entry. Treatment failure definition included: change of route for MTX monotherapy, adding or stopping a DMARD/biologic, and changing dose/frequency of a DMARD or biologic, due to inefficacy or a serious adverse event.
Results: We studied 1,484 early RA patients, the majority initiating either MTX monotherapy (oral or subcutaneous) or MTX plus a second agent (Table 1). At the time of entry into the early arthritis cohort, their mean (standard deviation, SD) age was 54 (15) years, their mean symptom duration was 5.6 months (2.8), their mean DAS28 scores were 5.3 (1.4), and one third (38%) were on oral steroids. Overall, 911/1464 (61%) had a treatment failure, primarily due to inefficacy (Table 1).
Table 1: Distribution of initial treatment and reasons for treatment failure
Treatment |
Frequency |
% |
Length of time remaining on initial treatment (months)* |
Any Failure |
Drug stopped due to inefficacy
|
Serious adverse effect
|
Any side effect§
|
|
Median |
Range |
|||||||
Oral MTX monotherapy |
398 |
26.8 |
6.0 |
0.3 to 95.9 |
313 (79%) |
13 (3.3%) |
0 (0%) |
70 (17.6%) |
Subcutaneous MTX monotherapy |
328 |
22.1 |
13.1 |
0.4 to 106.1 |
146 (45%) |
1 (0.3%) |
0 (0%) |
61 (18.6%) |
MTX plus a second DMARD |
642 |
43.3 |
9.3 |
0.3 to 107.8 |
375 (58%) |
23 (3.6%) |
0 (0%) |
168 (26.2%) |
MTX-HQN-SSZ |
116 |
7.8 |
9.8 |
0.3 to 96.8 |
77 (66%) |
7 (6.0%) |
1 (0.9%) |
58 (50.0%) |
Total |
1484 |
100.0 |
9.0 |
0.3 to 107.8 |
911 (61%) |
44 (3.0%) |
1 (0.1%) |
357 (24.1%) |
§ The variable reason to stop, serious adverse events and any side effects are MD recorded.
The multivariate cox regression (Table 2) for the first analyses showed that, compared to oral MTX monotherapy, all MTX strategies had longer time to failure.
Table 2: Adjusted hazard rations (HR) for drug changes after time zero* compared to oral MTX monotherapy (the reference)
Treatment at time zero |
Adjusted HR |
95% CI |
MTX subcutaneous monotherapy |
0.91 |
0.61, 1.35 |
MTX + another DMARD |
0.87 |
0.62 1.22 |
MTX+SSZ+HCQ |
0.64 |
0.44, 0.94 |
Biologics+/- DMARDs including MTX |
0.31 |
0.20, 0.49 |
Non MTX DMARDs only |
1.26 |
0.89, 1.77 |
*Adjusting for baseline characteristics: age, sex, co-morbidities, symptom duration, race, education, smoking, erosions, DAS-28, disease activity, corticosteroids, NSAIDs, and COXIBs.
Conclusion: Our data in early RA patients initially exposed to MTX suggest that compared to oral MTX, all other MTX strategies had longer time to failure. These data do not confirm clear differences in outcomes with respect to methotrexate DMARD combinations, as the width of confidence intervals precludes definitive conclusions in this regard.
To cite this abstract in AMA style:
Bernatsky S, Schieir O, Moura CS, Valois MF, Bartlett SJ, Hitchon CA, Pope JE, Boire G, Haraoui B, Keystone EC, Tin D, Thorne C, Bykerk VP. Methotrexate Treatment Strategies in an Early Rheumatoid Arthritis Cohort [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/methotrexate-treatment-strategies-in-an-early-rheumatoid-arthritis-cohort/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/methotrexate-treatment-strategies-in-an-early-rheumatoid-arthritis-cohort/