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Clinical benefit of 1-year certolizumab pegol (CZP) add-on therapy to methotrexate treatment in patients with early rheumatoid arthritis was observed following CZP discontinuation : 2-year results of the C-OPERA study, a phase III randomised trial
- Source :
- Annals of the Rheumatic Diseases
- Publication Year :
- 2017
- Publisher :
- BMJ Publishing Group, 2017.
-
Abstract
- ObjectivesTo investigate the clinical impact of 1-year certolizumab pegol (CZP) therapy added to the first year of 2-year methotrexate (MTX) therapy, compared with 2-year therapy with MTX alone.MethodsMTX-naïve patients with early rheumatoid arthritis (RA) with poor prognostic factors were eligible to enter Certolizumab-Optimal Prevention of joint damage for Early RA (C-OPERA), a multicentre, randomised, controlled study, which consisted of a 52-week double-blind (DB) period and subsequent 52-week post treatment (PT) period. Patients were randomised to optimised MTX+CZP (n=159) or optimised MTX+placebo (PBO; n=157). Following the DB period, patients entered the PT period, receiving MTX alone (CZP+MTX→MTX; n=108, PBO+MTX→MTX; n=71). Patients who flared could receive rescue treatment with open-label CZP.Results34 CZP+MTX→MTX patients and 14 PBO+MTX→MTX patients discontinued during the PT period. From week 52 through week 104, significant inhibition of total modified total Sharp score progression was observed for CZP+MTX versus PBO+MTX (week 104: 84.2% vs 67.5% (pConclusionsIn MTX-naïve patients with early RA with poor prognostic factors, an initial 1 year of add-on CZP to 2-year optimised MTX therapy brings radiographic and clinical benefit through 2 years, even after stopping CZP.Trial registration numberNCT01451203.
- Subjects :
- 0301 basic medicine
Male
DMARDs (biologic)
Gastroenterology
Anti-TNF
Arthritis, Rheumatoid
0302 clinical medicine
Deprescriptions
immune system diseases
Early Rheumatoid Arthritis
Immunology and Allergy
heterocyclic compounds
Certolizumab pegol
skin and connective tissue diseases
Methotrexate treatment
Remission Induction
Middle Aged
Prognosis
Treatment Outcome
Antirheumatic Agents
Retreatment
Disease Progression
Drug Therapy, Combination
Female
medicine.drug
musculoskeletal diseases
Adult
medicine.medical_specialty
Immunology
Placebo
General Biochemistry, Genetics and Molecular Biology
03 medical and health sciences
Rheumatology
Double-Blind Method
Internal medicine
Early Medical Intervention
medicine
Humans
In patient
030203 arthritis & rheumatology
business.industry
Early rheumatoid arthritis
Clinical and Epidemiological Research
Surgery
Discontinuation
Add on therapy
030104 developmental biology
Methotrexate
Certolizumab Pegol
business
Subjects
Details
- Language :
- English
- ISSN :
- 00034967
- Volume :
- 76
- Issue :
- 8
- Database :
- OpenAIRE
- Journal :
- Annals of the rheumatic diseases
- Accession number :
- edsair.doi.dedup.....f0264354d227309c4f380111b83e1763