Maxime R Dougados1, Désirée M van der Heijde2, Yves Brault2, Andrew S Koenig2, Isabelle S Logeart2. 1. From Paris-Descartes University and the Rheumatology B Department, Cochin Hospital, Paris, France; the Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Pfizer France, Paris, France; and Pfizer Inc., Collegeville, Pennsylvania, USA.M.R. Dougados, MD, Professor of Rheumatology, Paris-Descartes University and Rheumatology B Department, Cochin Hospital; D.M. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; Y. Brault, MS, Director of Biostatistics, Pfizer France; A.S. Koenig, DO, Inflammation and Immunology Group Lead, North America Medical Affairs, Pfizer Inc.; I.S. Logeart, MD, Medical Director, Inflammation Europe, Pfizer France. maxime.dougados@cch.aphp.fr. 2. From Paris-Descartes University and the Rheumatology B Department, Cochin Hospital, Paris, France; the Department of Rheumatology, Leiden University Medical Center, Leiden, The Netherlands; Pfizer France, Paris, France; and Pfizer Inc., Collegeville, Pennsylvania, USA.M.R. Dougados, MD, Professor of Rheumatology, Paris-Descartes University and Rheumatology B Department, Cochin Hospital; D.M. van der Heijde, MD, PhD, Professor of Rheumatology, Leiden University Medical Center; Y. Brault, MS, Director of Biostatistics, Pfizer France; A.S. Koenig, DO, Inflammation and Immunology Group Lead, North America Medical Affairs, Pfizer Inc.; I.S. Logeart, MD, Medical Director, Inflammation Europe, Pfizer France.
Abstract
OBJECTIVE: The objective of these posthoc analyses was to evaluate short-term clinical outcomes as predictors of poor response after 1 year of treatment with combination etanercept/methotrexate (ETN/MTX) therapy versus MTX monotherapy in patients with early rheumatoid arthritis (RA). METHODS:Participants with moderate to severe RA [28-joint Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) ≥ 3.2] of 3-24 months' duration receivedETN 50 mg weekly plus MTX or MTX monotherapy for 52 weeks. Regression analyses were performed to evaluate the likelihood of remission (DAS28-ESR < 2.6) after 1 year despite poor clinical short-term treatment effects (e.g., absolute or changes from baseline in DAS28-ESR after 4, 8, 12, 20, and 24 weeks of therapy). RESULTS: The magnitude of disease activity and its improvement and timing influenced remission probability in both treatment groups; remission rate was diminished with higher disease activity levels and lower response levels over time from weeks 4 to 24. The rate of DAS28-ESR remission at 1 year was generally greater with ETN/MTX than with MTX alone at most timepoints from weeks 4 to 24. Despite persistent high disease activity (DAS28-ESR > 5.1) after 4, 8, 12, and 24 weeks of therapy, 35%, 27%, 25%, and 22% of patients, respectively, in the ETN/MTX group achieved DAS28-ESR remission after 1 year of continuous treatment; the respective proportions were 33%, 27%, 8%, and 13% in the MTX group. CONCLUSION:High disease activity and less improvement with treatment over time in the initial 24 weeks of treatment, particularly after 12 weeks, were predictive of a lower remission rate after 1 year.
RCT Entities:
OBJECTIVE: The objective of these posthoc analyses was to evaluate short-term clinical outcomes as predictors of poor response after 1 year of treatment with combination etanercept/methotrexate (ETN/MTX) therapy versus MTX monotherapy in patients with early rheumatoid arthritis (RA). METHODS:Participants with moderate to severe RA [28-joint Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) ≥ 3.2] of 3-24 months' duration received ETN 50 mg weekly plus MTX or MTX monotherapy for 52 weeks. Regression analyses were performed to evaluate the likelihood of remission (DAS28-ESR < 2.6) after 1 year despite poor clinical short-term treatment effects (e.g., absolute or changes from baseline in DAS28-ESR after 4, 8, 12, 20, and 24 weeks of therapy). RESULTS: The magnitude of disease activity and its improvement and timing influenced remission probability in both treatment groups; remission rate was diminished with higher disease activity levels and lower response levels over time from weeks 4 to 24. The rate of DAS28-ESR remission at 1 year was generally greater with ETN/MTX than with MTX alone at most timepoints from weeks 4 to 24. Despite persistent high disease activity (DAS28-ESR > 5.1) after 4, 8, 12, and 24 weeks of therapy, 35%, 27%, 25%, and 22% of patients, respectively, in the ETN/MTX group achieved DAS28-ESR remission after 1 year of continuous treatment; the respective proportions were 33%, 27%, 8%, and 13% in the MTX group. CONCLUSION: High disease activity and less improvement with treatment over time in the initial 24 weeks of treatment, particularly after 12 weeks, were predictive of a lower remission rate after 1 year.
Entities:
Keywords:
BIOLOGIC AGENTS; EARLY RHEUMATOID ARTHRITIS; ETANERCEPT; METHOTREXATE; REMISSION; TREATMENT
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