A Fifty-Two–Week, Randomized, Placebo-Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis

Autor: Robert Landewé, Lars Bauer, Jonathan Kay, Martin Rudwaleit, B. Kilgallen, Atul Deodhar, Walter P. Maksymowych, Nigil Haroon, Désirée van der Heijde, Bengt Hoepken, Lianne S. Gensler, Stephen Hall, Natasha de Peyrecave
Přispěvatelé: Clinical Immunology and Rheumatology, AII - Inflammatory diseases
Jazyk: angličtina
Rok vydání: 2019
Předmět:
Adult
Male
medicine.medical_specialty
Clinical Trials and Supportive Activities
Immunology
Placebo-controlled study
Placebo
law.invention
03 medical and health sciences
0302 clinical medicine
Rheumatology
Randomized controlled trial
Double-Blind Method
Clinical Research
law
Internal medicine
Spondyloarthritis
medicine
Clinical endpoint
Immunology and Allergy
Humans
In patient
030212 general & internal medicine
Sacroiliitis
Certolizumab pegol
Axial spondyloarthritis
030203 arthritis & rheumatology
Ankylosing spondylitis
business.industry
Arthritis
Evaluation of treatments and therapeutic interventions
Middle Aged
medicine.disease
Magnetic Resonance Imaging
C-Reactive Protein
Treatment Outcome
6.1 Pharmaceuticals
Certolizumab Pegol
Spondylarthropathies
Original Article
Female
Tumor Necrosis Factor Inhibitors
business
medicine.drug
Zdroj: Arthritis & rheumatology (Hoboken, N.J.), vol 71, iss 7
Arthritis and Rheumatology, 71(7), 1101-1111. WILEY
Arthritis & Rheumatology (Hoboken, N.j.)
Arthritis & rheumatology (Hoboken, N.J.), 71(7), 1101-1111. John Wiley and Sons Ltd
ISSN: 2326-5191
Popis: Author(s): Deodhar, Atul; Gensler, Lianne S; Kay, Jonathan; Maksymowych, Walter P; Haroon, Nigil; Landewe, Robert; Rudwaleit, Martin; Hall, Stephen; Bauer, Lars; Hoepken, Bengt; de Peyrecave, Natasha; Kilgallen, Brian; van der Heijde, Desiree | Abstract: ObjectiveThe natural history of nonradiographic axial spondyloarthritis (SpA) is incompletely characterized, and there are concerns that nonsteroidal antiinflammatory drugs provide inadequate disease control in patients with active disease. This study was undertaken to investigate the effects of certolizumab pegol (CZP), an anti-tumor necrosis factor treatment, in patients with nonradiographic axial SpA with objective signs of inflammation.MethodsIn this ongoing parallel-group double-blind study, adults with active disease were recruited from 80 centers in Australia, Europe, North America, and Taiwan, and were randomized 1:1 to receive placebo or CZP (400 mg at weeks 0, 2, and 4, followed by 200 mg every 2 weeks) in addition to nonbiologic background medication (NBBM). Switching to open-label CZP (or other biologic) or making background medication changes was permitted at any point during the trial, although changes before week 12 were discouraged. The primary end point was the proportion of patients achieving major improvement (MI) (i.e., a ≥2.0-point decrease in the score from baseline or achievement of the lowest possible score [0.6]) in the Ankylosing Spondylitis Disease Activity Score (ASDAS) at week 52.ResultsA total of 317 patients were randomized to receive placebo plus NBBM (n = 158) or CZP plus NBBM (n = 159). ASDAS-MI at week 52 was achieved in 47.2% (75 of 159) of CZP plus NBBM patients, which was significantly greater (P l 0.0001) than the 7.0% (11 of 158) of placebo plus NBBM patients in whom ASDAS-MI was achieved. Of the placebo plus NBBM patients, 60.8% (96 of 158) switched to open-label treatment before week 52 compared to 12.6% (20 of 159) of the CZP plus NBBM patients.ConclusionAdding CZP to background medication is superior to adding placebo in patients with active nonradiographic axial SpA. These results indicate that remission in nonradiographic axial SpA treated without biologics occurs infrequently, demonstrating the need for treatment beyond nonbiologic therapy.
Databáze: OpenAIRE
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