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.
Author(s): Hara M(1), Ishiguro N, Katayama K, Kondo M, Sumida T, Mimori T, Soen S, Nagai K,
Yamaguchi T, Yamamoto K; Iguratimod-Clinical Study Group.
Collaborators: Katayama K, Yukawa N, Soen S, Eguchi K, Kawakami A, Ohno S,
Yoshida T, Fukuda T, Hashimoto K, Sato T, Takahashi Y, Sugiyama E, Kohriyama K,
Munakata Y, Kitamura K, Amano K, Miyashima S, Sagawa A, Sakurai T, Yamane H,
Hirose W, Nakashima H, Yoshitama T, Hirota K, Kaneko M, Matsuta K, Fujisaku A,
Mine M, Yano S, Oki I, Chijiwa T, Mukai M, Aoki K, Nakashima M, Kishi J, Kanamono
T, Ohta S, Tsukada T, Ueki Y, Tsuboi S, Takahashi H, Tsuchiya H, Izumiyama T,
Oishi Y, Hirano Y, Kato T, Yamaguchi S, Nagamine T, Furugo I, Takagi Y, Sumida T,
Kanda R, Maeda K, Tsuru T, Kondo M, Naito M, Nishinarita M, Nagashima M, Miyake
H, Ayabe T, Amma H, Oguchi T, Takahashi M, Morio H, Hiraguri M, Kurihara M,
Matsumoto H, Fujimori J, Tsurukami H, Nakamura H, Suda A, Hagiyama H, Nakashima
A, Kontani T, Kamei S, Maruyama T, Shinomiya F, Yoshizawa S, Tanimura K,
Hashimoto K, Kawamura H, Nara H, Sato H, Hidaka S, Murase K, Irahara M, Suzuki S,
Kawakami M, Shono E, Obata J, Oribe M, Uchida S, Nakajima M, Sawabe T, Ishikawa
K, Munesada S, Ohira T, Yoshida M, Matsubara T, Honjo S, Yamanishi Y.
Affiliation(s): Author information:
(1)Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
Publication date & source: 2014, Mod Rheumatol. , 24(3):410-8
OBJECTIVE: To obtain safety and efficacy data on combination treatment with
iguratimod and methotrexate (MTX) in an open-label extension study in patients
with active rheumatoid arthritis (RA).
METHODS: Following a 28-week, randomized, double-blind trial of adding iguratimod
or placebo to stable MTX therapy, patients entered a 24-week extension. Patients
randomized to the iguratimod + MTX group continued treatment. Patients treated
with placebo + MTX switched to iguratimod + MTX [the (placebo/iguratimod) + MTX
group].
RESULTS: In the iguratimod + MTX group, the rate of 20% improvement in American
College of Rheumatology criteria (ACR20) at week 52 (71.3%) was similar to that
at week 24 (69.5%). ACR50, ACR70 and Health Assessment Questionnaire Disability
Index at week 52 significantly improved compared with the values at week 24. In
the (placebo/iguratimod + MTX) group, the switch to iguratimod treatment
significantly improved ACR20 from 30.7% at week 24 to 72.1% at week 52. Frequent
adverse events for 52 weeks in the iguratimod + MTX group were nasopharyngitis,
upper respiratory tract inflammation, stomatitis, lymphocyte decrease, AST
increase, ALT increase and blood iron decrease. These adverse events were
predominantly mild or moderate in severity. No deaths occurred.
CONCLUSION: Efficacy and tolerance of iguratimod + MTX therapy was maintained to
52 weeks in patients with active RA with inadequate response to MTX.
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