Effectiveness and safety of subcutaneous abatacept in biologic-naïve RA patients at Week 52: A Japanese multicentre investigational study (ORIGAMI study).
Mod Rheumatol
; 32(5): 846-856, 2022 Aug 20.
Article
in En
| MEDLINE
| ID: mdl-34915575
ABSTRACT
OBJECTIVES:
To evaluate the effectiveness and safety of abatacept over 52 weeks in biologic-naïve rheumatoid arthritis (RA) patients with moderate disease activity in the prospective, 5-year, observational study (ORIGAMI study) in Japan.METHODS:
Abatacept (125 mg) was administered subcutaneously once a week. Clinical outcomes included Simplified Disease Activity Index (SDAI) remission at Week 52 (primary endpoint), Japanese Health Assessment Questionnaire (J-HAQ), EuroQol 5-Dimension Questionnaire (EQ-5D), treatment retention, and safety. The results were compared with those of conventional synthetic disease-modifying antirheumatic drug (csDMARD) controls from the ongoing Institute of Rheumatology, Rheumatoid Arthritis (IORRA) registry.RESULTS:
Overall, 325 patients were enrolled, with a mean age of 66.9 ± 12.7 years. The proportion of patients achieving SDAI remission (≤3.3) at Week 52 was 18.9% (95% CI 14.3-23.6) and low disease activity (≤11) was 53.3% (95% CI 47.4-59.1). A significant improvement was observed in J-HAQ and EQ-5D over 52 weeks in both the abatacept and csDMARD groups. The probability of abatacept treatment retention at Week 52 was 69.9% (95% CI 64.7-75.5). Adverse events and serious adverse events were reported in 50.0% and 12.1% of patients, respectively.CONCLUSIONS:
Abatacept significantly improved disease activity, physical disability, and quality of life for up to 52 weeks in RA patients in a real-world setting.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Arthritis, Rheumatoid
/
Biological Products
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Antirheumatic Agents
Type of study:
Clinical_trials
/
Observational_studies
Limits:
Aged
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Humans
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Middle aged
Country/Region as subject:
Asia
Language:
En
Year:
2022
Type:
Article