Insights into the efficacy of golimumab plus methotrexate in patients with active rheumatoid arthritis who discontinued prior anti-tumour necrosis factor therapy

Post-hoc analyses from the GO-AFTER study

Josef S. Smolen, Jonathan Kay, Eric Lawrence Matteson, Robert Landewé, Elizabeth C. Hsia, Stephen Xu, Yiying Zhou, Mittie K. Doyle

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

Objective Evaluate golimumab in patients with active rheumatoid arthritis (RA) and previous tumour necrosis factor-a (TNF) inhibitor use. Methods Patients (n=461) previously receiving =1 TNF inhibitor were randomised to subcutaneous injections of placebo, golimumab 50 mg or golimumab 100 mg q4 weeks. Primary endpoint (=20% improvement in American College of Rheumatology (ACR20) criteria at week 14) findings have been reported for all patients in the trial. Reported herein are further assessments of efficacy/safety among patients receiving golimumab +methotrexate (MTX). Results Among efficacy-evaluable patients who received MTX at baseline, more receiving golimumab +MTX (n=201) than placebo+MTX (n=103) achieved ACR20 (40.8% vs 14.6%), ACR50 (20.9% vs 3.9%), and ACR70 (11.4% vs 2.9%) responses at week 24. Among the 137 patients who had received only one prior TNF inhibitor (adalimumab, n=33; etanercept, n=47; and infliximab, n=57), week 24 ACR20 rates were 30.3%, 46.8% and 50.9%, respectively, and thus lowest among those who previously used adalimumab. ACR20 response rates were 44.5% (61/137), 36.2% (17/47) and 23.5% (4/17) among patients who had received one, two or three TNF inhibitors, respectively. Adverse event (AE) rates were comparable across type/number of prior anti-TNF agents, but appeared somewhat higher among patients who discontinued previous TNF inhibitor(s) due to intolerance (37/49, 75.5%) versus lack of efficacy (LOE, 113/191, 59.2%). Conclusions Patients with active RA previously treated with =1 TNF inhibitor had clinically relevant improvement with golimumab+MTX, which appeared somewhat enhanced among those who received only etanercept or infliximab as their prior TNF inhibitor. Golimumab+MTX safety appeared similar across patients, regardless of TNF inhibitor(s) previously used, with fewer AEs occurring among patients who discontinued prior therapy for LOE.

Original languageEnglish (US)
JournalAnnals of the Rheumatic Diseases
DOIs
StateAccepted/In press - Jul 29 2013

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Methotrexate
Rheumatoid Arthritis
Tumor Necrosis Factor-alpha
Therapeutics
Placebos
golimumab
Subcutaneous Injections
Patient Safety
Safety

ASJC Scopus subject areas

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

Cite this

Insights into the efficacy of golimumab plus methotrexate in patients with active rheumatoid arthritis who discontinued prior anti-tumour necrosis factor therapy : Post-hoc analyses from the GO-AFTER study. / Smolen, Josef S.; Kay, Jonathan; Matteson, Eric Lawrence; Landewé, Robert; Hsia, Elizabeth C.; Xu, Stephen; Zhou, Yiying; Doyle, Mittie K.

In: Annals of the Rheumatic Diseases, 29.07.2013.

Research output: Contribution to journalArticle

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title = "Insights into the efficacy of golimumab plus methotrexate in patients with active rheumatoid arthritis who discontinued prior anti-tumour necrosis factor therapy: Post-hoc analyses from the GO-AFTER study",
abstract = "Objective Evaluate golimumab in patients with active rheumatoid arthritis (RA) and previous tumour necrosis factor-a (TNF) inhibitor use. Methods Patients (n=461) previously receiving =1 TNF inhibitor were randomised to subcutaneous injections of placebo, golimumab 50 mg or golimumab 100 mg q4 weeks. Primary endpoint (=20{\%} improvement in American College of Rheumatology (ACR20) criteria at week 14) findings have been reported for all patients in the trial. Reported herein are further assessments of efficacy/safety among patients receiving golimumab +methotrexate (MTX). Results Among efficacy-evaluable patients who received MTX at baseline, more receiving golimumab +MTX (n=201) than placebo+MTX (n=103) achieved ACR20 (40.8{\%} vs 14.6{\%}), ACR50 (20.9{\%} vs 3.9{\%}), and ACR70 (11.4{\%} vs 2.9{\%}) responses at week 24. Among the 137 patients who had received only one prior TNF inhibitor (adalimumab, n=33; etanercept, n=47; and infliximab, n=57), week 24 ACR20 rates were 30.3{\%}, 46.8{\%} and 50.9{\%}, respectively, and thus lowest among those who previously used adalimumab. ACR20 response rates were 44.5{\%} (61/137), 36.2{\%} (17/47) and 23.5{\%} (4/17) among patients who had received one, two or three TNF inhibitors, respectively. Adverse event (AE) rates were comparable across type/number of prior anti-TNF agents, but appeared somewhat higher among patients who discontinued previous TNF inhibitor(s) due to intolerance (37/49, 75.5{\%}) versus lack of efficacy (LOE, 113/191, 59.2{\%}). Conclusions Patients with active RA previously treated with =1 TNF inhibitor had clinically relevant improvement with golimumab+MTX, which appeared somewhat enhanced among those who received only etanercept or infliximab as their prior TNF inhibitor. Golimumab+MTX safety appeared similar across patients, regardless of TNF inhibitor(s) previously used, with fewer AEs occurring among patients who discontinued prior therapy for LOE.",
author = "Smolen, {Josef S.} and Jonathan Kay and Matteson, {Eric Lawrence} and Robert Landew{\'e} and Hsia, {Elizabeth C.} and Stephen Xu and Yiying Zhou and Doyle, {Mittie K.}",
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T2 - Post-hoc analyses from the GO-AFTER study

AU - Smolen, Josef S.

AU - Kay, Jonathan

AU - Matteson, Eric Lawrence

AU - Landewé, Robert

AU - Hsia, Elizabeth C.

AU - Xu, Stephen

AU - Zhou, Yiying

AU - Doyle, Mittie K.

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N2 - Objective Evaluate golimumab in patients with active rheumatoid arthritis (RA) and previous tumour necrosis factor-a (TNF) inhibitor use. Methods Patients (n=461) previously receiving =1 TNF inhibitor were randomised to subcutaneous injections of placebo, golimumab 50 mg or golimumab 100 mg q4 weeks. Primary endpoint (=20% improvement in American College of Rheumatology (ACR20) criteria at week 14) findings have been reported for all patients in the trial. Reported herein are further assessments of efficacy/safety among patients receiving golimumab +methotrexate (MTX). Results Among efficacy-evaluable patients who received MTX at baseline, more receiving golimumab +MTX (n=201) than placebo+MTX (n=103) achieved ACR20 (40.8% vs 14.6%), ACR50 (20.9% vs 3.9%), and ACR70 (11.4% vs 2.9%) responses at week 24. Among the 137 patients who had received only one prior TNF inhibitor (adalimumab, n=33; etanercept, n=47; and infliximab, n=57), week 24 ACR20 rates were 30.3%, 46.8% and 50.9%, respectively, and thus lowest among those who previously used adalimumab. ACR20 response rates were 44.5% (61/137), 36.2% (17/47) and 23.5% (4/17) among patients who had received one, two or three TNF inhibitors, respectively. Adverse event (AE) rates were comparable across type/number of prior anti-TNF agents, but appeared somewhat higher among patients who discontinued previous TNF inhibitor(s) due to intolerance (37/49, 75.5%) versus lack of efficacy (LOE, 113/191, 59.2%). Conclusions Patients with active RA previously treated with =1 TNF inhibitor had clinically relevant improvement with golimumab+MTX, which appeared somewhat enhanced among those who received only etanercept or infliximab as their prior TNF inhibitor. Golimumab+MTX safety appeared similar across patients, regardless of TNF inhibitor(s) previously used, with fewer AEs occurring among patients who discontinued prior therapy for LOE.

AB - Objective Evaluate golimumab in patients with active rheumatoid arthritis (RA) and previous tumour necrosis factor-a (TNF) inhibitor use. Methods Patients (n=461) previously receiving =1 TNF inhibitor were randomised to subcutaneous injections of placebo, golimumab 50 mg or golimumab 100 mg q4 weeks. Primary endpoint (=20% improvement in American College of Rheumatology (ACR20) criteria at week 14) findings have been reported for all patients in the trial. Reported herein are further assessments of efficacy/safety among patients receiving golimumab +methotrexate (MTX). Results Among efficacy-evaluable patients who received MTX at baseline, more receiving golimumab +MTX (n=201) than placebo+MTX (n=103) achieved ACR20 (40.8% vs 14.6%), ACR50 (20.9% vs 3.9%), and ACR70 (11.4% vs 2.9%) responses at week 24. Among the 137 patients who had received only one prior TNF inhibitor (adalimumab, n=33; etanercept, n=47; and infliximab, n=57), week 24 ACR20 rates were 30.3%, 46.8% and 50.9%, respectively, and thus lowest among those who previously used adalimumab. ACR20 response rates were 44.5% (61/137), 36.2% (17/47) and 23.5% (4/17) among patients who had received one, two or three TNF inhibitors, respectively. Adverse event (AE) rates were comparable across type/number of prior anti-TNF agents, but appeared somewhat higher among patients who discontinued previous TNF inhibitor(s) due to intolerance (37/49, 75.5%) versus lack of efficacy (LOE, 113/191, 59.2%). Conclusions Patients with active RA previously treated with =1 TNF inhibitor had clinically relevant improvement with golimumab+MTX, which appeared somewhat enhanced among those who received only etanercept or infliximab as their prior TNF inhibitor. Golimumab+MTX safety appeared similar across patients, regardless of TNF inhibitor(s) previously used, with fewer AEs occurring among patients who discontinued prior therapy for LOE.

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