Rituximab in routine care of severe active rheumatoid arthritis : A prospective, non-interventional study in Germany.
Z Rheumatol
; 78(9): 881-888, 2019 Nov.
Article
in En
| MEDLINE
| ID: mdl-30276727
ABSTRACT
OBJECTIVE:
To assess safety, effectiveness and onset of effect of rituximab (RTX) in routine clinical treatment of severe, active rheumatoid arthritis (RA).METHODS:
Prospective, multi-centre, non-interventional study in rheumatological outpatient clinics or private practices in Germany. RTX-naïve adult patients were to receive RTX according to marketing authorisation and at their physician's discretion. Also according to their physician's discretion, patients could receive a second cycle of RTX (re-treatmentâ¯= treatment continuation). Major outcome was the change in Disease Activity Score based on 28-joints count and erythrocyte sedimentation rate (DAS28-ESR) over 24 weeks and during 6 months of re-treatment.RESULTS:
Overall, 1653 patients received at least one cycle RTX; 99.2% of these had received disease-modifying antirheumatic drugs (DMARD) pre-treatment and 75.5% anti-tumor necrosis factor(TNF)α pre-treatment. After a mean interval of 8.0 months, 820 patients received RTX re-treatment. Mean DAS28-ESR decreased from 5.3â¯at baseline to 3.8 after 24 weeks (-1.5 [95% confidence interval, CI -1.6; -1.4]), and from 4.1â¯at start of cycle 2 to 3.5â¯at study end (change from baseline -1.8 [95% CI -2.0; -1.7]). Improvements in DAS28-ESR and Health Assessment Questionnaire (HAQ) score occurred mainly during the first 12 weeks of RTX treatment, with further DAS28-ESR improvement until week 24 or month 6 of re-treatment. Improvements in DAS28-ESR and EULAR responses were more pronounced in seropositive patients. RF was a predictor of DAS28-ESR change to study end. Safety analysis showed the established profile of RTX.CONCLUSION:
RTX was safe and effective in a real-life setting with rapid and sustained improvement in RA signs and symptoms.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Arthritis, Rheumatoid
/
Antirheumatic Agents
/
Rituximab
Type of study:
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Adult
/
Humans
Country/Region as subject:
Europa
Language:
En
Journal:
Z Rheumatol
Year:
2019
Type:
Article
Affiliation country:
Germany