Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors: Results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160

Josef S. Smolen, Jonathan Kay, Robert B M Landewé, Eric Lawrence Matteson, Norman Gaylis, Jurgen Wollenhaupt, Frederick T. Murphy, Yiying Zhou, Elizabeth C. Hsia, Mittie K. Doyle

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Abstract

Objective: The aim of this study was to assess long-term golimumab therapy in patients with rheumatoid arthritis (RA) who discontinued previous tumour necrosis factor alpha (TNFα) inhibitor(s) for any reason. Methods: Results through week 24 of this multicentre, randomised, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) were previously reported. Patients received placebo (Group 1), 50 mg golimumab (Group 2) or 100 mg golimumab (Group 3) subcutaneous injections every 4 weeks. Patients from Groups 1 and 2 with <20% improvement in tender/swollen joints at week 16 early escaped to golimumab 50 mg and 100 mg, respectively. At week 24, Group 1 patients crossed over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status and Group 3 maintained dosing. Data through week 160 are reported. Results: 459 of the 461 randomised patients were treated; 236/459 (51%) continued treatment through week 160. From week 24 to week 100, ACR20 (≥20% improvement in American College of Rheumatology criteria) response and ≥0.25 unit HAQ (Health Assessment Questionnaire) improvement were sustained in 70-73% and 75-81% of responding patients, respectively. Overall at week 160, 63%, 67% and 57% of patients achieved ACR20 response and 59%, 65% and 64% had HAQ improvement ≥0.25 unit in Groups 1, 2 and 3, respectively. Adjusted for follow-up duration, adverse event incidences (95% CI) per 100 patient-years among patients treated with golimumab 50 mg and 100 mg were 4.70 (2.63 to 7.75) and 8.07 (6.02 to 10.58) for serious infection, 0.95 (0.20 to 2.77) and 2.04 (1.09 to 3.49) for malignancy and 0.00 (0.00 to 0.94) and 0.62 (0.17 to 1.59) for death, respectively. Conclusion: In patients with active RA who discontinued previous TNF-antagonist treatment, golimumab 50 and 100 mg injections every 4 weeks yielded sustained improvements in signs/symptoms and physical function in ∼57-67% of patients who continued treatment. Golimumab safety was consistent with other anti-TNF agents, although definitive conclusions regarding long-term safety require further monitoring.

Original languageEnglish (US)
Pages (from-to)1671-1679
Number of pages9
JournalAnnals of the Rheumatic Diseases
Volume71
Issue number10
DOIs
StatePublished - Oct 2012

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Rheumatoid Arthritis
Tumor Necrosis Factor-alpha
Placebos
Health
golimumab
Joints
Safety
Subcutaneous Injections
Therapeutics
Signs and Symptoms
Monitoring
Injections
Incidence
Infection

ASJC Scopus subject areas

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

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Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors : Results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160. / Smolen, Josef S.; Kay, Jonathan; Landewé, Robert B M; Matteson, Eric Lawrence; Gaylis, Norman; Wollenhaupt, Jurgen; Murphy, Frederick T.; Zhou, Yiying; Hsia, Elizabeth C.; Doyle, Mittie K.

In: Annals of the Rheumatic Diseases, Vol. 71, No. 10, 10.2012, p. 1671-1679.

Research output: Contribution to journalArticle

Smolen, Josef S. ; Kay, Jonathan ; Landewé, Robert B M ; Matteson, Eric Lawrence ; Gaylis, Norman ; Wollenhaupt, Jurgen ; Murphy, Frederick T. ; Zhou, Yiying ; Hsia, Elizabeth C. ; Doyle, Mittie K. / Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors : Results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160. In: Annals of the Rheumatic Diseases. 2012 ; Vol. 71, No. 10. pp. 1671-1679.
@article{1763468b39a44dcf82957a3652d94b75,
title = "Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors: Results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160",
abstract = "Objective: The aim of this study was to assess long-term golimumab therapy in patients with rheumatoid arthritis (RA) who discontinued previous tumour necrosis factor alpha (TNFα) inhibitor(s) for any reason. Methods: Results through week 24 of this multicentre, randomised, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) were previously reported. Patients received placebo (Group 1), 50 mg golimumab (Group 2) or 100 mg golimumab (Group 3) subcutaneous injections every 4 weeks. Patients from Groups 1 and 2 with <20{\%} improvement in tender/swollen joints at week 16 early escaped to golimumab 50 mg and 100 mg, respectively. At week 24, Group 1 patients crossed over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status and Group 3 maintained dosing. Data through week 160 are reported. Results: 459 of the 461 randomised patients were treated; 236/459 (51{\%}) continued treatment through week 160. From week 24 to week 100, ACR20 (≥20{\%} improvement in American College of Rheumatology criteria) response and ≥0.25 unit HAQ (Health Assessment Questionnaire) improvement were sustained in 70-73{\%} and 75-81{\%} of responding patients, respectively. Overall at week 160, 63{\%}, 67{\%} and 57{\%} of patients achieved ACR20 response and 59{\%}, 65{\%} and 64{\%} had HAQ improvement ≥0.25 unit in Groups 1, 2 and 3, respectively. Adjusted for follow-up duration, adverse event incidences (95{\%} CI) per 100 patient-years among patients treated with golimumab 50 mg and 100 mg were 4.70 (2.63 to 7.75) and 8.07 (6.02 to 10.58) for serious infection, 0.95 (0.20 to 2.77) and 2.04 (1.09 to 3.49) for malignancy and 0.00 (0.00 to 0.94) and 0.62 (0.17 to 1.59) for death, respectively. Conclusion: In patients with active RA who discontinued previous TNF-antagonist treatment, golimumab 50 and 100 mg injections every 4 weeks yielded sustained improvements in signs/symptoms and physical function in ∼57-67{\%} of patients who continued treatment. Golimumab safety was consistent with other anti-TNF agents, although definitive conclusions regarding long-term safety require further monitoring.",
author = "Smolen, {Josef S.} and Jonathan Kay and Landew{\'e}, {Robert B M} and Matteson, {Eric Lawrence} and Norman Gaylis and Jurgen Wollenhaupt and Murphy, {Frederick T.} and Yiying Zhou and Hsia, {Elizabeth C.} and Doyle, {Mittie K.}",
year = "2012",
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doi = "10.1136/annrheumdis-2011-200956",
language = "English (US)",
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pages = "1671--1679",
journal = "Annals of the Rheumatic Diseases",
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T1 - Golimumab in patients with active rheumatoid arthritis who have previous experience with tumour necrosis factor inhibitors

T2 - Results of a long-term extension of the randomised, double-blind, placebo-controlled GO-AFTER study through week 160

AU - Smolen, Josef S.

AU - Kay, Jonathan

AU - Landewé, Robert B M

AU - Matteson, Eric Lawrence

AU - Gaylis, Norman

AU - Wollenhaupt, Jurgen

AU - Murphy, Frederick T.

AU - Zhou, Yiying

AU - Hsia, Elizabeth C.

AU - Doyle, Mittie K.

PY - 2012/10

Y1 - 2012/10

N2 - Objective: The aim of this study was to assess long-term golimumab therapy in patients with rheumatoid arthritis (RA) who discontinued previous tumour necrosis factor alpha (TNFα) inhibitor(s) for any reason. Methods: Results through week 24 of this multicentre, randomised, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) were previously reported. Patients received placebo (Group 1), 50 mg golimumab (Group 2) or 100 mg golimumab (Group 3) subcutaneous injections every 4 weeks. Patients from Groups 1 and 2 with <20% improvement in tender/swollen joints at week 16 early escaped to golimumab 50 mg and 100 mg, respectively. At week 24, Group 1 patients crossed over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status and Group 3 maintained dosing. Data through week 160 are reported. Results: 459 of the 461 randomised patients were treated; 236/459 (51%) continued treatment through week 160. From week 24 to week 100, ACR20 (≥20% improvement in American College of Rheumatology criteria) response and ≥0.25 unit HAQ (Health Assessment Questionnaire) improvement were sustained in 70-73% and 75-81% of responding patients, respectively. Overall at week 160, 63%, 67% and 57% of patients achieved ACR20 response and 59%, 65% and 64% had HAQ improvement ≥0.25 unit in Groups 1, 2 and 3, respectively. Adjusted for follow-up duration, adverse event incidences (95% CI) per 100 patient-years among patients treated with golimumab 50 mg and 100 mg were 4.70 (2.63 to 7.75) and 8.07 (6.02 to 10.58) for serious infection, 0.95 (0.20 to 2.77) and 2.04 (1.09 to 3.49) for malignancy and 0.00 (0.00 to 0.94) and 0.62 (0.17 to 1.59) for death, respectively. Conclusion: In patients with active RA who discontinued previous TNF-antagonist treatment, golimumab 50 and 100 mg injections every 4 weeks yielded sustained improvements in signs/symptoms and physical function in ∼57-67% of patients who continued treatment. Golimumab safety was consistent with other anti-TNF agents, although definitive conclusions regarding long-term safety require further monitoring.

AB - Objective: The aim of this study was to assess long-term golimumab therapy in patients with rheumatoid arthritis (RA) who discontinued previous tumour necrosis factor alpha (TNFα) inhibitor(s) for any reason. Methods: Results through week 24 of this multicentre, randomised, double-blind, placebo-controlled study of active RA (≥4 tender, ≥4 swollen joints) were previously reported. Patients received placebo (Group 1), 50 mg golimumab (Group 2) or 100 mg golimumab (Group 3) subcutaneous injections every 4 weeks. Patients from Groups 1 and 2 with <20% improvement in tender/swollen joints at week 16 early escaped to golimumab 50 mg and 100 mg, respectively. At week 24, Group 1 patients crossed over to golimumab 50 mg, Group 2 continued golimumab 50/100 mg per escape status and Group 3 maintained dosing. Data through week 160 are reported. Results: 459 of the 461 randomised patients were treated; 236/459 (51%) continued treatment through week 160. From week 24 to week 100, ACR20 (≥20% improvement in American College of Rheumatology criteria) response and ≥0.25 unit HAQ (Health Assessment Questionnaire) improvement were sustained in 70-73% and 75-81% of responding patients, respectively. Overall at week 160, 63%, 67% and 57% of patients achieved ACR20 response and 59%, 65% and 64% had HAQ improvement ≥0.25 unit in Groups 1, 2 and 3, respectively. Adjusted for follow-up duration, adverse event incidences (95% CI) per 100 patient-years among patients treated with golimumab 50 mg and 100 mg were 4.70 (2.63 to 7.75) and 8.07 (6.02 to 10.58) for serious infection, 0.95 (0.20 to 2.77) and 2.04 (1.09 to 3.49) for malignancy and 0.00 (0.00 to 0.94) and 0.62 (0.17 to 1.59) for death, respectively. Conclusion: In patients with active RA who discontinued previous TNF-antagonist treatment, golimumab 50 and 100 mg injections every 4 weeks yielded sustained improvements in signs/symptoms and physical function in ∼57-67% of patients who continued treatment. Golimumab safety was consistent with other anti-TNF agents, although definitive conclusions regarding long-term safety require further monitoring.

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