Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: Results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks

Tsutomu Takeuchi, Masayoshi Harigai, Yoshiya Tanaka, Hisashi Yamanaka, Naoki Ishiguro, Kazuhiko Yamamoto, Nobuyuki Miyasaka, Takao Koike, Minoru Kanazawa, Takuya Oba, Toru Yoshinari, Daniel Baker

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Abstract

Objective: To evaluate the efficacy and safety of golimumab 50 and 100 mg monotherapy in Japanese patients with active rheumatoid arthritis (RA) despite treatment with disease-modifying antirheumatic drugs (DMARDs). Methods: A total of 316 patients were randomised to receive subcutaneous injections every 4 weeks of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3); group 1 crossed over to golimumab 50 mg at week 16. The primary end point was the proportion of patients achieving ≥20% improvement in the American College of Rheumatology criteria (ACR20) at week 14. ACR50 and ACR70 response rates were also measured. Adverse events (AEs) were monitored throughout the study. Results: Demographics were similar across groups; the mean age was 52 years and 81.8% of patients (252/308) were female. Week 14 ACR20 response rates were significantly greater in groups 2 (51/101 (50.5%)) and 3 (60/102 (58.8%)) than in group 1 (20/105 (19.0%); p<0.0001 for both), as were ACR50 and ACR70 response rates. After placebo crossover at week 16, week 24 ACR response rates were similar in groups 1 and 2. Through week 16, 63.8% of patients in group 1, 62.4% in group 2 and 60.8% in group 3 had AEs and 1.9%, 1.0% and 2.0% had serious AEs. After week 16, one malignancy was reported (breast cancer, group 3). Infections were the most common AEs. No deaths or cases of tuberculosis were reported through week 24. Conclusions: Golimumab monotherapy (50 and 100 mg) was effective in reducing the signs and symptoms of RA in Japanese patients with active disease despite DMARD treatment.

Original languageEnglish
Pages (from-to)1488-1495
Number of pages8
JournalAnnals of the Rheumatic Diseases
Volume72
Issue number9
DOIs
Publication statusPublished - 2013 Sep

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Antirheumatic Agents
Rheumatoid Arthritis
Placebos
Drug therapy
Therapeutics
Subcutaneous Injections
Signs and Symptoms
golimumab
Tuberculosis
Demography
Safety
Infection
Neoplasms

ASJC Scopus subject areas

  • Rheumatology
  • Immunology
  • Biochemistry, Genetics and Molecular Biology(all)
  • Immunology and Allergy

Cite this

Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs : Results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. / Takeuchi, Tsutomu; Harigai, Masayoshi; Tanaka, Yoshiya; Yamanaka, Hisashi; Ishiguro, Naoki; Yamamoto, Kazuhiko; Miyasaka, Nobuyuki; Koike, Takao; Kanazawa, Minoru; Oba, Takuya; Yoshinari, Toru; Baker, Daniel.

In: Annals of the Rheumatic Diseases, Vol. 72, No. 9, 09.2013, p. 1488-1495.

Research output: Contribution to journalArticle

Takeuchi, Tsutomu ; Harigai, Masayoshi ; Tanaka, Yoshiya ; Yamanaka, Hisashi ; Ishiguro, Naoki ; Yamamoto, Kazuhiko ; Miyasaka, Nobuyuki ; Koike, Takao ; Kanazawa, Minoru ; Oba, Takuya ; Yoshinari, Toru ; Baker, Daniel. / Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs : Results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. In: Annals of the Rheumatic Diseases. 2013 ; Vol. 72, No. 9. pp. 1488-1495.
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abstract = "Objective: To evaluate the efficacy and safety of golimumab 50 and 100 mg monotherapy in Japanese patients with active rheumatoid arthritis (RA) despite treatment with disease-modifying antirheumatic drugs (DMARDs). Methods: A total of 316 patients were randomised to receive subcutaneous injections every 4 weeks of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3); group 1 crossed over to golimumab 50 mg at week 16. The primary end point was the proportion of patients achieving ≥20{\%} improvement in the American College of Rheumatology criteria (ACR20) at week 14. ACR50 and ACR70 response rates were also measured. Adverse events (AEs) were monitored throughout the study. Results: Demographics were similar across groups; the mean age was 52 years and 81.8{\%} of patients (252/308) were female. Week 14 ACR20 response rates were significantly greater in groups 2 (51/101 (50.5{\%})) and 3 (60/102 (58.8{\%})) than in group 1 (20/105 (19.0{\%}); p<0.0001 for both), as were ACR50 and ACR70 response rates. After placebo crossover at week 16, week 24 ACR response rates were similar in groups 1 and 2. Through week 16, 63.8{\%} of patients in group 1, 62.4{\%} in group 2 and 60.8{\%} in group 3 had AEs and 1.9{\%}, 1.0{\%} and 2.0{\%} had serious AEs. After week 16, one malignancy was reported (breast cancer, group 3). Infections were the most common AEs. No deaths or cases of tuberculosis were reported through week 24. Conclusions: Golimumab monotherapy (50 and 100 mg) was effective in reducing the signs and symptoms of RA in Japanese patients with active disease despite DMARD treatment.",
author = "Tsutomu Takeuchi and Masayoshi Harigai and Yoshiya Tanaka and Hisashi Yamanaka and Naoki Ishiguro and Kazuhiko Yamamoto and Nobuyuki Miyasaka and Takao Koike and Minoru Kanazawa and Takuya Oba and Toru Yoshinari and Daniel Baker",
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T2 - Results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks

AU - Takeuchi, Tsutomu

AU - Harigai, Masayoshi

AU - Tanaka, Yoshiya

AU - Yamanaka, Hisashi

AU - Ishiguro, Naoki

AU - Yamamoto, Kazuhiko

AU - Miyasaka, Nobuyuki

AU - Koike, Takao

AU - Kanazawa, Minoru

AU - Oba, Takuya

AU - Yoshinari, Toru

AU - Baker, Daniel

PY - 2013/9

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N2 - Objective: To evaluate the efficacy and safety of golimumab 50 and 100 mg monotherapy in Japanese patients with active rheumatoid arthritis (RA) despite treatment with disease-modifying antirheumatic drugs (DMARDs). Methods: A total of 316 patients were randomised to receive subcutaneous injections every 4 weeks of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3); group 1 crossed over to golimumab 50 mg at week 16. The primary end point was the proportion of patients achieving ≥20% improvement in the American College of Rheumatology criteria (ACR20) at week 14. ACR50 and ACR70 response rates were also measured. Adverse events (AEs) were monitored throughout the study. Results: Demographics were similar across groups; the mean age was 52 years and 81.8% of patients (252/308) were female. Week 14 ACR20 response rates were significantly greater in groups 2 (51/101 (50.5%)) and 3 (60/102 (58.8%)) than in group 1 (20/105 (19.0%); p<0.0001 for both), as were ACR50 and ACR70 response rates. After placebo crossover at week 16, week 24 ACR response rates were similar in groups 1 and 2. Through week 16, 63.8% of patients in group 1, 62.4% in group 2 and 60.8% in group 3 had AEs and 1.9%, 1.0% and 2.0% had serious AEs. After week 16, one malignancy was reported (breast cancer, group 3). Infections were the most common AEs. No deaths or cases of tuberculosis were reported through week 24. Conclusions: Golimumab monotherapy (50 and 100 mg) was effective in reducing the signs and symptoms of RA in Japanese patients with active disease despite DMARD treatment.

AB - Objective: To evaluate the efficacy and safety of golimumab 50 and 100 mg monotherapy in Japanese patients with active rheumatoid arthritis (RA) despite treatment with disease-modifying antirheumatic drugs (DMARDs). Methods: A total of 316 patients were randomised to receive subcutaneous injections every 4 weeks of placebo (group 1), golimumab 50 mg (group 2) or golimumab 100 mg (group 3); group 1 crossed over to golimumab 50 mg at week 16. The primary end point was the proportion of patients achieving ≥20% improvement in the American College of Rheumatology criteria (ACR20) at week 14. ACR50 and ACR70 response rates were also measured. Adverse events (AEs) were monitored throughout the study. Results: Demographics were similar across groups; the mean age was 52 years and 81.8% of patients (252/308) were female. Week 14 ACR20 response rates were significantly greater in groups 2 (51/101 (50.5%)) and 3 (60/102 (58.8%)) than in group 1 (20/105 (19.0%); p<0.0001 for both), as were ACR50 and ACR70 response rates. After placebo crossover at week 16, week 24 ACR response rates were similar in groups 1 and 2. Through week 16, 63.8% of patients in group 1, 62.4% in group 2 and 60.8% in group 3 had AEs and 1.9%, 1.0% and 2.0% had serious AEs. After week 16, one malignancy was reported (breast cancer, group 3). Infections were the most common AEs. No deaths or cases of tuberculosis were reported through week 24. Conclusions: Golimumab monotherapy (50 and 100 mg) was effective in reducing the signs and symptoms of RA in Japanese patients with active disease despite DMARD treatment.

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