Therapeutic effects of the combination of methotrexate and bucillamine in early rheumatoid arthritis: A multicenter, double-blind, randomized controlled study

Yoichi Ichikawa, Terunobu Saito, Haisashi Yamanaka, Masashi Akizuki, Hirobumi Kondo, Shigeto Kobayashi, Hisaji Oshima, Shinichi Kawai, Nobuaki Hama, Hidehiro Yamada, Tsuneyo Mimori, Koichi Amano, Yasushi Tanaka, Yasuo Matsuoka, Sumiki Yamamoto, Tsukasa Matsubara, Norikazu Murata, Tomiaki Asai, Yasuo Suzuki, Yutaka OkanoTouru Akaboshi, Takao Fujii, Michito Hirakata, Takahiro Suzuki, Nobuo Takubo, Yasuyuki Miyata, Yukio Sato, Norihiro Nishimoto, Eizo Saito, Shigemasa Sawada, Akira Rikimaru, Hajime Yamagata, Shigeto Toma, Katsumi Ito, Katsumi Yoshida

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36 Citations (Scopus)

Abstract

Disease-modifying antirheumatic drug (DMARD) combination therapies are used widely, but there have been few reports clearly demonstrating that combination therapy is more effective than DMARD monotherapy. We conducted a multicenter, double-blind controlled trial in order to clarify that the combination of methotrexate and bucillamine is more effective than either alone. The subjects of this study were 71 patients with active rheumatoid arthritis within 2 years of onset. Dosages were 8mg methotrexate with 5 mg folic acid per week (MTX group), 200 mg bucillamine per day (BUC group), or both MTX and BUC (combination group). Clinical effects and adverse reactions were observed for 96 weeks. The ACR 20 response rate was 79.2% in the combination group, significantly higher than the rates of 43.5% for the MTX group (P = 0.008) and 45.8% for the BUC group (P = 0.0178). The cumulative survival curve of maintaining the ACR 20 response was significantly higher in the combination group than in the MTX and BUC groups (P = 0.0123 and P = 0.0088, respectively). The mean increase in the total Sharp score over 96 weeks was 12.6 ± 9.0 in the combination group, significantly lower (P = 0.0468) than the value of 28.0 ± 28.3 for the single DMARD (combined MTX and BUC) group. The incidence of adverse reactions did not differ significantly between the three groups. It was concluded that the combination therapy with MTX and BUC showed significantly higher clinical efficacy than either of the single DMARD therapies.

Original languageEnglish
Pages (from-to)323-328
Number of pages6
JournalModern rheumatology
Volume15
Issue number5
DOIs
Publication statusPublished - 2005 Oct 1

Keywords

  • Bucillamine
  • Combination therapy
  • Methotrexate
  • Rheumatoid arthritis

ASJC Scopus subject areas

  • Rheumatology

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    Ichikawa, Y., Saito, T., Yamanaka, H., Akizuki, M., Kondo, H., Kobayashi, S., Oshima, H., Kawai, S., Hama, N., Yamada, H., Mimori, T., Amano, K., Tanaka, Y., Matsuoka, Y., Yamamoto, S., Matsubara, T., Murata, N., Asai, T., Suzuki, Y., ... Yoshida, K. (2005). Therapeutic effects of the combination of methotrexate and bucillamine in early rheumatoid arthritis: A multicenter, double-blind, randomized controlled study. Modern rheumatology, 15(5), 323-328. https://doi.org/10.1007/s10165-005-0420-z