Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: An open-label extension of a randomized, double-blind, placebo-controlled trial

2013 ◽  
Vol 24 (3) ◽  
pp. 410-418 ◽  
Author(s):  
Masako Hara ◽  
Naoki Ishiguro ◽  
Kou Katayama ◽  
Masakazu Kondo ◽  
Takayuki Sumida ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Combination Therapy ◽  
Active Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Inadequate Response ◽  
Open Label ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
Open Label Extension

scholarly journals AB0350 EFFICACY OF ADDING IGURATIMOD THERAPY IN RHEUMATOID ARTHRITIS PATIENTS WHO HAD INADEQUATE RESPONSE TO BIOLOGIC DMARDS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1474.2-1474
Author(s):  
T. Miyamoto ◽  
K. Yamazaki
Keyword(s):  
Rheumatoid Arthritis ◽  
Controlled Trial ◽  
Previous Treatment ◽  
Inadequate Response ◽  
Open Label ◽  
Double Blind ◽  
Biologic Dmards ◽  
Duration Of Illness ◽  
Remission Rates ◽  
Open Label Extension

Background:Iguratimod (IGU) was newly approved in Japan in June 2012 and recommended by JCR guideline 2014 in the treatment of rheumatoid arthritis (RA). Although there have been efficacy of monotherapy and concomitant MTX in clinical trials, however, there have been no reports of concomitant biologic DMARDs (Bio).Objectives:we investigated efficacy of concomitant IGU therapy in RA patients who had inadequate response to Bio at the author’s institution.Methods:Subjects were 107 patients adding IGU who had inadequate response to Bio from Janually 2014 to October 2018. Previous treatment Bio. was ADA. And baseline mean concomitant MTX was 12.3 mg/week). And baseline characteristics were Mean age 53.8 years, mean duration of illness 5.5 years, corticosteroid use 9.3%(mean 3.1mg/day).The course of DAS28, SDAI, CDAI and remission rates were analyzed.Results:Mean DAS28-ESR, SDAI, CDAI were significantly decreased from the initiation of IGU treatment at 24 weeks (3.1→2.3, 7.1→2.7, 6.5→2.4), at 52 weeks (2.1, 2.4, 2.0). Remission rates of DAS28-ESR, SDAI, CDAI were 69.2%, 68.2%, 70.1% at 24 weeks, 74.8%, 78.5%, 79.4% at 52 weeks. There were no side-effect that must be stopped after adding IGU.Conclusion:IGU might be a new RA treatment option for aiming remission in patients who had inadequate response to Bio.References:[1]Hara M et al: Safety and efficacy of combination therapy of iguratimod with methotrexate for patients with active rheumatoid arthritis with an inadequate response to methotrexate: an open-label extension of a randomized, double-blind, placebo-controlled trial. Mod Rheumatol. 2014; 24: 410—418.Disclosure of Interests:None declared

scholarly journals Subcutaneous Abatacept for the Treatment of Rheumatoid Arthritis: Longterm Data from the ACQUIRE Trial

2014 ◽  
Vol 41 (4) ◽  
pp. 629-639 ◽  
Author(s):  
Mark C. Genovese ◽  
César Pacheco Tena ◽  
Arturo Covarrubias ◽  
Gustavo Leon ◽  
Eduardo Mysler ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Severe Disease ◽  
Incidence Rates ◽  
Phase Iii ◽  
Inadequate Response ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Link Type

Objective.Assess longterm tolerability, safety, and efficacy of subcutaneous (SC) abatacept (ABA) in methotrexate-refractory patients with rheumatoid arthritis (RA).Methods.The phase III, multinational Abatacept Comparison of Sub[QU]cutaneous Versus Intravenous in Inadequate Responders to MethotrexatE (ACQUIRE) trial comprised a 6-month, randomized, double-blind (DB) period, in which patients received intravenous (IV) or SC ABA, plus MTX, followed by an open-label, longterm extension (LTE), in which patients received SC ABA, 125 mg/week. Safety and efficacy from the LTE (∼3.5 yrs of exposure) are reported.Results.Patients who completed the DB period (1372/1385, 99.1%) entered the LTE; 1134 patients (82.7%) kept taking the treatment at time of reporting. Mean (SD) was 31.9 months (6.8); median (range) exposure was 33.0 (8–44) months. Patients entering the LTE had longstanding, moderate-to-severe disease [mean 7.6 (7.9) yrs and DAS28 (C-reactive protein) 6.2 (0.9)]. Incidence rates (events/100 patient-yrs) were reported for serious adverse events (8.76, 95% CI 7.71, 9.95), infections (44.80, 95% CI 41.76, 48.01), serious infections (1.72, 95% CI 1.30, 2.27), malignancies (1.19, 95% CI 0.86, 1.66), and autoimmune events (1.31, 95% CI 0.95, 1.79). Twenty-seven patients (2%) experienced injection-site reactions; all except 1 were mild. American College of Rheumatology 20, 50, and 70 responses achieved during the DB period were maintained through the LTE, and on Day 981 were 80.2% (95% CI 77.2, 83.2), 63.5% (95% CI 58.2, 68.9), and 39.5% (95% CI 34.0, 44.9) for patients who kept taking SC ABA, and 80.0% (95% CI 77.0, 83.0), 63.2% (95% CI 57.8, 68.7), and 39.2% (95% CI 33.7, 44.7) for those who switched from IV to SC ABA.Conclusion.These findings support SC ABA as a well-tolerated and efficacious longterm treatment for patients with RA and inadequate response to MTX (ClinicalTrials.gov identifier NCT00559585).

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