Golimumab in psoriatic arthritis: One-year clinical efficacy, radiographic, and safety results from a phase III, randomized, placebo-controlled trial
| Autor: | A. Baratelle, W. Xu, Dafna D. Gladman, Kim A. Papp, Iain B. McInnes, Zhenhua Xu, Surekha Mudivarthy, Juan J. Gomez-Reino, Michael Mack, Philip J. Mease, A. Beutler, Arthur Kavanaugh, Désirée van der Heijde, Mahboob Rahman, Julie Zrubek, Gerald G. Krueger |
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| Jazyk: | angličtina |
| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Hand Joints Injections Subcutaneous Immunology Placebo-controlled study Arthritis Placebo law.invention Psoriatic arthritis Double-Blind Method Rheumatology Randomized controlled trial law Foot Joints Internal medicine Humans Immunology and Allergy Medicine Pharmacology (medical) Longitudinal Studies Adverse effect Dose-Response Relationship Drug business.industry Arthritis Psoriatic Antibodies Monoclonal Middle Aged medicine.disease Golimumab Surgery Radiography Clinical trial Treatment Outcome Antirheumatic Agents Disease Progression Female business medicine.drug |
| Zdroj: | Arthritis and Rheumatism, 64(8), 2504-2517 |
| Popis: | Golimumab, administered subcutaneously every 4 weeks, has been shown to be effective in reducing the signs and symptoms of active psoriatic arthritis (PsA) through week 24 of the GO-REVEAL study. Herein we report 1-year clinical, radiographic, and safety findings.Adult patients with active PsA (≥3 swollen and ≥3 tender joints) were randomly assigned to receive subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks through week 20. At week 16, patients with10% improvement from baseline in swollen and tender joint counts entered a blinded early escape phase, with placebo crossover to golimumab 50 mg, golimumab 50 mg increased to 100 mg, and golimumab 100 mg continued at 100 mg. Patients receiving placebo who did not enter the early escape phase crossed over to golimumab 50 mg at week 24. Findings through 1 year are reported, including the second of 2 coprimary end points (i.e., change from baseline to week 24 in PsA-modified Sharp/van der Heijde score [SHS]).A total of 405 patients were randomized: 113 to placebo and 146 each to the golimumab 50 mg and 100 mg groups. Mean changes in PsA-modified SHS from baseline to week 24 for the combined golimumab 50 mg and 100 mg group (-0.09) and the golimumab 50 mg group (-0.16) were significantly different versus placebo (0.27) (P = 0.015 and P = 0.011, respectively). Radiographic benefit was maintained through week 52 with golimumab. Clinical efficacy, including improvement in joint and skin responses and physical function, was maintained through 1 year. The frequency/types of adverse events were similar to those reported through week 24.Treatment of PsA with golimumab inhibited structural damage progression and demonstrated continued clinical efficacy and safety through 1 year. |
| Databáze: | OpenAIRE |
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