Effectiveness, Tolerability, and Safety of Belimumab in Patients with Refractory SLE: a Review of Observational Clinical-Practice-Based Studies

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.

BAFF and BAFF-Receptor in B Cell Selection and Survival

“…So far, the BAFF-neutralizing monoclonal antibody belimumab is the only FDA- and EMA-approved biological drug for the treatment of patients with active refractory SLE. Application of the anti-BAFF antibody leads to a persistent, 50% improvement in about half of the SLE patients as reflected by lower anti-dsDNA titers, less corticosteroids, less cutaneous manifestations and less flares, while its adverse effects are similar as but less severe than the defects observed in BAFFR-deficiency and include respiratory, digestive and urinary tract infections [reviewed in ( 113 )]. However, because of the lack of matched control groups, the efficacy of belimumab is still not completely clear.…”

Real-world treatment patterns, healthcare resource utilisation and costs in patients with systemic lupus erythematosus treated with belimumab: a retrospective analysis of claims data in the USA

“…SLE treatments include antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids and immunosuppressants 14. Due to persistent disease activity, a high proportion of patients require long-term corticosteroid and/or immunosuppressive treatment, which clinical studies suggest contributes to progressive organ damage accrual 15 16.…”

SERPINB3 Delays Glomerulonephritis and Attenuates the Lupus-Like Disease in Lupus Murine Models by Inducing a More Tolerogenic Immune Phenotype

“…It should be reminded that perturbation of homeostatic pathways is often involved in the development of autoimmunity and in SLE immunomodulatory therapies targeting self-molecules and cytokines are released or underway ( 27 – 30 ). Actually, most of these drugs aim at reducing the hyperactivation of physiological signals ( 31 ), while the case of SERPINB3 would require the restoration of a normally activated pathway that is instead downregulated in SLE.…”