Apremilast in Patients With Active Rheumatoid Arthritis: A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study

Arthritis & Rheumatology
M C GenoveseFarrukh Zaidi

Abstract

To study the efficacy/safety of apremilast, an oral phosphodiesterase 4 inhibitor, compared with placebo in patients with active rheumatoid arthritis (RA) who had an inadequate response to methotrexate (MTX). Patients were randomized 1:1:1 to receive placebo, apremilast 20 mg twice a day, or apremilast 30 mg twice a day. Patients whose swollen and tender joint counts had not improved by ≥20% were considered nonresponders at week 16 and were required to enter the protocol-defined early escape. At week 24, patients were transitioned in a blinded manner to receive apremilast 20 mg twice a day if they were initially randomized to receive placebo. Patients who were not initially randomized to receive placebo continued to receive their target apremilast dose. Patients were required to take a stable dose of MTX (7.5-25 mg/week) throughout the study. Magnetic resonance imaging (MRI) was performed in a subset of patients. A total of 237 patients who were receiving MTX therapy were randomized and received ≥1 dose of study medication. At week 16, similar proportions of patients receiving placebo (35%), apremilast 20 mg twice a day (28%), and apremilast 30 mg twice a day (34%) met the American College of Rheumatology criteria for 20% impro...Continue Reading

References

Feb 1, 1980·Arthritis and Rheumatism·J F FriesH R Holman

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Citations

Apr 26, 2019·Annals of the Rheumatic Diseases·Charlie BridgewoodDennis G McGonagle
Sep 1, 2018·RMD Open·Joseph F MerolaRoy Fleischmann
Oct 5, 2017·Biomolecules·Pratiek N MatkarKrishna K Singh
Dec 14, 2019·Nature Reviews. Rheumatology·Kathryn M KingsmorePeter E Lipsky
Mar 2, 2016·Current Opinion in Rheumatology·Ashish J MathewPhilip G Conaghan
Sep 6, 2019·Nature Reviews. Rheumatology·Arlene Bravo, Arthur Kavanaugh
Jan 6, 2019·Nature Reviews. Rheumatology·Dennis McGonaglePhilip Helliwell
Apr 3, 2019·The Journal of Dermatological Treatment·Nolan J MaloneyKyle Cheng
Dec 31, 2020·International Journal of Molecular Sciences·Alexandra DamerauAnnemarie Lang
Apr 1, 2021·Rheumatology·Yannick DegboéCarl S Goodyear

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