A Fifty‐Two–Week, Randomized, Placebo‐Controlled Trial of Certolizumab Pegol in Nonradiographic Axial Spondyloarthritis
Objective The 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 ce...
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| Published in: | Arthritis & rheumatology (Hoboken, N.J.) Vol. 71; no. 7; pp. 1101 - 1111 |
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| Main Authors: | , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
Wiley Subscription Services, Inc
01.07.2019
John Wiley and Sons Inc |
| Subjects: | |
| ISSN: | 2326-5191, 2326-5205, 2326-5205 |
| Online Access: | Get full text |
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| Summary: | Objective
The 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.
Methods
In 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.
Results
A 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 < 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.
Conclusion
Adding 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. |
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| Bibliography: | ObjectType-Article-2 SourceType-Scholarly Journals-1 content type line 14 ObjectType-Feature-3 ObjectType-Evidence Based Healthcare-1 ObjectType-Article-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 Supported by UCB Pharma. ClinicalTrials.gov identifier: NCT02552212. UCB Pharma will share anonymized patient‐level data and additional information including clinical study report, study protocols, and statistical analysis plan. Dr. Deodhar has received consulting fees from AbbVie, Janssen, Pfizer, and UCB Pharma (less than $10,000 each), and from Eli Lilly and Novartis (more than $10,000 each) and research support from those companies. Dr. Gensler has received consulting fees from Galapagos, Eli Lilly, Janssen, and Pfizer (less than $10,000 each) and research support from UCB Pharma, AbbVie, Amgen, and Novartis. Dr. Kay has received consulting fees from AbbVie, Amgen, Boehringer Ingelheim, Celltrion Healthcare, Janssen, Merck, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, and UCB Pharma (less than $10,000 each) and research support from AbbVie, Gilead Sciences, Pfizer, Roche, and UCB Pharma. Dr. Maksymowych has received consulting fees and/or honoraria from AbbVie, Eli Lilly, Boehringer, Galapagos, Janssen, Novartis, Pfizer, and UCB Pharma (less than $10,000 each), research support from AbbVie, Pfizer, Janssen, and Novartis, and is Chief Medical Officer of Canadian Research and Education Arthritis. Dr. Haroon has received consulting fees from AbbVie, Amgen, Janssen, Merck, Novartis, and UCB Pharma (less than $10,000 each). Dr. Landewé has received consulting fees from AbbVie, Ablynx, Amgen, AstraZeneca, Bristol‐Myers Squibb, Centocor, Galapagos, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Roche, Schering, and UCB Pharma (less than $10,000 each) and research support from those companies. Dr. Rudwaleit has received consulting fees, speaking fees, and/or honoraria from AbbVie, Bristol‐Myers Squibb, Celgene, Janssen, Eli Lilly, MSD, Novartis, Pfizer, Roche, and UCB Pharma (less than $10,000 each). Dr. Hall has received consulting fees from AbbVie, Eli Lilly, Novartis, and UCB Pharma (less than $10,000 each) and research support from those companies. Dr. van der Heijde has received consulting fees from AbbVie, Amgen, Astellas, AstraZeneca, Bristol‐Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi, and UCB Pharma (less than $10,000 each) and is director of Imaging Rheumatology BV. No other disclosures relevant to this article were reported. |
| ISSN: | 2326-5191 2326-5205 2326-5205 |
| DOI: | 10.1002/art.40866 |