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Effectiveness, Tolerability, and Safety of Belimumab in Patients with Refractory SLE: a Review of Observational Clinical-Practice-Based Studies
- Source :
- Clinical Reviews in Allergy & Immunology. 54:331-343
- Publication Year :
- 2018
- Publisher :
- Springer Science and Business Media LLC, 2018.
-
Abstract
- To date, belimumab is the only biological drug approved for the treatment of patients with active refractory SLE. We compared and critically analyzed the results of 11 observational clinical-practice-based studies, conducted in SLE referral centers. Despite the differences in endpoints and follow-up duration, all studies remarked that belimumab provides additional benefits when used as an add-on to existing treatment, allowing a higher rate of patients to reach remission and to taper or discontinue corticosteroids. In the OBSErve studies, 2–9.6% of patients discontinued corticosteroids and 72–88.4% achieved a ≥ 20% improvement by physician’s judgment at 6 months. In Hui-Yuen’s study, 51% of patients attained response by simplified SRI at month 6. In Sthoeger’s study, 72.3% of patients discontinued corticosteroids and 69.4% achieved clinical remission by PGA after a median follow-up of 2.3 years. In the multicentric Italian study, 77 and 68.7% of patients reached SRI-4 response at months 6 and 12, respectively. In all the studies, disease activity indices decreased over time. Retention rates at 6, 9, and 12 months were 82–94.1, 61.2–83.3, and 56.7–79.2%, respectively. The main limitations of these studies include the lack of a control group, the short period of observation (6–24 months) and the lack of precise restrictions regarding concomitant medication management. This notwithstanding, these experiences provide a more realistic picture of real-life effectiveness of the drug compared with the randomized controlled clinical trials, where stringent inclusion/exclusion criteria and changes in background therapy could limit the inference of data to the routine clinical care.
- Subjects :
- Pediatrics
medicine.medical_specialty
Referral
Real-life experience
Systemic lupus erythematous
Efficacy
03 medical and health sciences
0302 clinical medicine
Refractory
Drug survival
medicine
Immunology and Allergy
030212 general & internal medicine
030203 arthritis & rheumatology
business.industry
General Medicine
Belimumab
Clinical trial
Drug efficacy
Tolerability
Concomitant
Observational study
BLyS
business
medicine.drug
Subjects
Details
- ISSN :
- 15590267 and 10800549
- Volume :
- 54
- Database :
- OpenAIRE
- Journal :
- Clinical Reviews in Allergy & Immunology
- Accession number :
- edsair.doi.dedup.....1b3d59d5da3dc1fa3aee611a47c66dcf