Session Title: Rheumatoid Arthritis - Clinical Aspects Poster Session III
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
is routinely used as the first-line drug for rheumatoid arthritis (RA). About 1
in 3 RA patients achieve excellent RA control with MTX monotherapy. Identifying
predictors of MTX response could allow treatment optimization, avoid drug
toxicities and treatment delays while saving costs.
Potential baseline clinical
predictors were studied in two cohorts: Rheumatology & Arthritis
Investigational Network (RAIN) Early Predictors Study and Treatment of Early
Aggressive Rheumatoid Arthritis (TEAR) trial. RAIN is a 16-week, open-label
study where RA patients are started on weekly po MTX 15mg and escalated to 20
mg at 8 weeks if not in remission (DAS-28 ESR< 2.6). Clinical and laboratory
parameters are collected at baseline, 8, and 16 weeks. TEAR was a randomized, double-blind
study using 4 treatment arms: two arms with immediate combination therapy and
two step-up arms. We analyzed patients from TEAR step-up arms who initially were
on po MTX monotherapy. Primary outcome was absolute change in DAS-28 (baseline
to 16 weeks for RAIN and baseline to 12 weeks for TEAR) adjusted for the baseline.
Low disease activity (LDA; DAS28 <3.2) was a secondary outcome. Data were analyzed using ordinary least squares and
(75% female, 89% white) completed the 16-week RAIN trial. Mean (SD) change in
DAS-28 from baseline to 16 weeks was -1.90 (1.50) with LDA achieved by 51%. Male
gender (p=0.015), white race (p=0.019) and lower baseline neutrophil (BNC) count
(p=0.011) were associated with significant improvement in DAS-28ESR (Table).
Male gender, higher hemoglobin and lower BNC were significantly associated with
achieving LDA (not shown).
Patients (n=297) who
received MTX monotherapy during TEAR were also analyzed (70% female, 81% white).
Mean (SD) change in DAS-28 from baseline to 12 weeks was -1.28 (1.19) with LDA achieved
by 20%. Male gender (p=0.016), lower baseline tender joint counts (p=0.037)
and lower baseline aspartate transaminase (p=0.020) were associated with
primary outcome (Table). Lower BNC showed a non-significant trend towards DAS28
improvement. Male gender, lower swollen joint count and higher hemoglobin were
associated with LDA (not shown).
In both cohorts,
male gender and white race were associated with significant improvement in
DAS28ESR with MTX monotherapy; higher baseline hemoglobin was also associated
with achieving LDA. Lower BNC was associated with good response (absolute
change and LDA) to MTX in RAIN cohort, but only showed a trend in the TEAR
cohort. Larger studies with a focus on pharmaco-genetics may be required to
identify the RA patients who are ideal candidates for MTX monotherapy.
To cite this abstract in AMA style:Danve A, Sayles H, Mikuls TR, O'Dell JR. Male Gender and Higher Hemoglobin Predict Response to Methotrexate in Rheumatoid Arthritis [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). https://acrabstracts.org/abstract/male-gender-and-higher-hemoglobin-predict-response-to-methotrexate-in-rheumatoid-arthritis/. Accessed January 26, 2022.
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