Background/Purpose:

According to clinical practice guidelines for patients with rheumatoid arthritis (RA), after failure to a c-DMARD (conventional disease modifying antirheumatic drug) can be chosen either by the combination with another c-DMARD, or by the addition of b-DMARD (biological) or ts-DMARD (target synthetic). The most frequent c-DMARD combination therapy in our country is methotrexate (MTX) plus lefunomide (LEF).

The objective is to compare the survival and safety of treatment between two cohorts of patients with RA who have failed to c-DMARD monotherapy: one with combination of MTX + LEF (cohort A) and the other with the first b-DMARD (cohort B).

Methods:

Patients ≥18 years old with RA (ACR 1987 or ACR/EULAR 2010 criteria), who received treatment with MTX plus LEF or with the first b-DMARD therapy after failing c-DMARD monotherapy were included. Sociodemographic, clinical and therapeutic variables were recorded. Disease activity was assessed by DAS28. The adverse events (AE) that occurred during the treatment, the severity of them, as well as, the interruptions of the treatment were consigned. The causes of discontinuation and survival of both types of treatment were evaluated. Statistical analysis: Descriptive statistics. Chi ² test, Student’s T test and/or Mann Whitney test. Multiple logistic regression analysis. Kaplan Meier curves and Log Rank test for survival analysis.

Results:

202 patients were included, median age was 58 years old (IQR 50.7-65), 86.6% were female and the median disease duration was 15 years (IQR 9-22). 69.8% had associated comorbidities. 100 patients (49.5%) were in cohort A and 102 (50.5%) were in cohort B. No baseline differences were found related to the clinical characteristics, except for the prevalence of previous tuberculosis (Cohort A 5.2% vs cohort B 0%, p= 0.02) and heart failure (Cohort A 7.4% vs cohort B 1%, p= 0.03). We did not observe differences in treatment survival between both cohorts [Cohort A: mean 121.2 months (95%CI: 100.3-142) and cohort B: mean 77.1 months (95%CI 63.3-91), p = 0.2]. 47.6% of cohort A permanently or temporarily suspended therapy vs 52.4% of cohort B (p = 0.67), being the most frequent causes of discontinuation: for cohort A inefficacy (31.1%) and AE for cohort B (55.8%). 56.9% suffered at least one AE and 60% of them were receiving concomitant corticosteroids. The infections were more frequent in cohort B 39.7% vs cohort A 19.6% (p = 0.02). In multivariate analysis, adjusting for age and disease duration, corticosteroid treatment was associated with the presence of AE (OR: 19.8, 95% CI: 6.23-57.6, p <0.001) regardless of the type of treatment, and the use of biological therapy was associated with higher risk of infections (OR 2.7, 95%CI: 1.15-6.34, p = 0.02) regardless of the use of concomitant corticosteroids.

Conclusion:

Treatment survival in both cohorts was comparable. The frequency of infections was higher in cohort with b-DMARD. Concomitant treatment with steroids increased the risk of AE, regardless of the type of treatment.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/comparison-of-adverse-events-and-survival-of-treatment-in-patients-with-rheumatoid-arthritis-receiving-combined-treatment-of-methotrexate-and-leflunomide-versus-those-receiving-biological-therapy/