Ревматология: текущие исследования
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Metothrexate Plus Leflunomide Step-Up Therapy in Early Rheumatoid Arthritis Patients with Non-Response to Initial Methotrexate Monotherapy

Carlevaris L, Citera G, Soriano ER, Pellet C, Manzano M, Amaya CG, Martire MV, Bennasar G, Secco A, Landi M, Del Para F, Waimann CA, Ceccato F, Paira S, Caeiro F, Salinas HMJ, Benzaquen N, Pirola J, Bertiller E, Rosa J, Marcos J, García MA, Costi AC, Munoz MA, Rillo O, Berman H, Berman A, Colombres F, Velozo EJ, Juarez V0, Crespo M0, Quinteros A, Leal M, Salvatierra G, Ledesma C, Sacnun M, Quintana R, Abdala M

Methods: We included a cohort of patients with diagnosis of early RA of less than 2 years of disease duration who not respond to MTX monotherapy, according to medical judgment, and added step-up combination with LEF. Data were collected every 3 months, including sociodemographic characteristics, functional status, disease activity and treatment. The primary outcome was the time to remission with the combined therapy, defined according to disease activity index of 28 joints (DAS28). Combination treatment failure was defined as not achieving remission. Time of outcome was assessed from date of the start of MTX plus LEF combination to date of remission or last follow-up. The Kaplan-Meier product limit method was used to estimate the probability of each outcome.

Results: A total of 106 patients were included. The median disease duration was 4 (IQR 2-8) months. Median followup was 34 ± 18 months (300 patients-year). Mean age was 50 ± 12 years and 83% were female. At the time of LEF addition, 95 (90%) of patients were not in remission. During follow-up, 47 (50%) achieved clinical remission at a median time of 8 months. The rest of the patients failed to achieve remission. The overall probability of remission per patients-months of follow-up was 0.49. Twenty seven out of 47 patients (58%) were still in remission at the last follow up visit (median follow-up after first remission=19 months).

Conclusion: In early RA patients with non-response to MTX monotherapy, the addition of LEF allowed to achieve remission in 50% of patients, at a median time of 8 months. Six out of ten of these patients were still in remission after almost 2 years of follow-up.