Maintenance of clinical remission in early axial spondyloarthritis following certolizumab pegol dose reduction.
Ann Rheum Dis
; 79(7): 920-928, 2020 07.
Article
en En
| MEDLINE
| ID: mdl-32381562
ABSTRACT
BACKGROUND:
The best strategy for maintaining clinical remission in patients with axial spondyloarthritis (axSpA) has not been defined. C-OPTIMISE compared dose continuation, reduction and withdrawal of the tumour necrosis factor inhibitor certolizumab pegol (CZP) following achievement of sustained remission in patients with early axSpA.METHODS:
C-OPTIMISE was a two-part, multicentre phase 3b study in adults with early active axSpA (radiographic or non-radiographic). During the 48-week open-label induction period, patients received CZP 200 mg every 2 weeks (Q2W). At Week 48, patients in sustained remission (Ankylosing Spondylitis Disease Activity Score (ASDAS) <1.3 at Weeks 32/36 and 48) were randomised to double-blind CZP 200 mg Q2W (full maintenance dose), CZP 200 mg every 4 weeks (Q4W; reduced maintenance dose) or placebo (withdrawal) for a further 48 weeks. The primary endpoint was remaining flare-free (flare ASDAS ≥2.1 at two consecutive visits or ASDAS >3.5 at any time point) during the double-blind period.RESULTS:
At Week 48, 43.9% (323/736) patients achieved sustained remission, of whom 313 were randomised to CZP full maintenance dose, CZP reduced maintenance dose or placebo. During Weeks 48 to 96, 83.7% (87/104), 79.0% (83/105) and 20.2% (21/104) of patients receiving the full maintenance dose, reduced maintenance dose or placebo, respectively, were flare-free (p<0.001 vs placebo in both CZP groups). Responses in radiographic and non-radiographic axSpA patients were comparable.CONCLUSIONS:
Patients with early axSpA who achieve sustained remission at 48 weeks can reduce their CZP maintenance dose; however, treatment should not be completely discontinued due to the high risk of flare following CZP withdrawal. TRIAL REGISTRATION NUMBER NCT02505542, ClinicalTrials.gov.Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Antirreumáticos
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Espondiloartritis
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Quimioterapia de Mantención
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Certolizumab Pegol
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Inhibidores del Factor de Necrosis Tumoral
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Ann Rheum Dis
Año:
2020
Tipo del documento:
Article
País de afiliación:
Países Bajos