When to use belimumab in SLE

Gatto, Mariele; Iaccarino, Leonardo; Zen, Margherita; Doria, Andrea

doi:10.1080/1744666x.2017.1324784

Cited by 16 publications

(10 citation statements)

References 14 publications

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“…Prolonged remission is associated with a decrease in damage progression [ 51 – 54 ] and, therefore, better outcomes. Regarding the predictors of treatment efficacy, real-life experience [ 42 ] confirmed the results of the pooled post hoc analysis of the phase III clinical trials [ 55 ]: Patients who are more likely to respond to belimumab display an active disease with acute mucocutaneous and musculoskeletal manifestations, active serology, and high prednisone intake (≥ 7.5 mg/day) with a relapsing-remitting course.…”

Section: Discussionmentioning

confidence: 80%

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

Trentin

Gatto

Zen

et al. 2018

Clinic Rev Allerg Immunol

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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.

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Section: Discussionmentioning

confidence: 80%

“…The earlier the use of belimumab in SLE course, the better the clinical response, as logically expected. Alternatively, belimumab may be used as an add-on to treatment when refractory manifestations persist despite the use of immunosuppressants [ 42 ].…”

Section: Belimumab In the Current Management Of Sle: Expert Opinionmentioning

confidence: 99%

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

Trentin

Gatto

Zen

et al. 2018

Clinic Rev Allerg Immunol

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“… 6 Therefore, belimumab is cost-effective both in terms of employment and in decreasing health resource utilization. 6 …”

Section: Introductionmentioning

confidence: 99%

“…[3][4][5] Since its approval, evidence from clinical practice has demonstrated that belimumab is associated with improvements in control of disease activity, reductions in fatigue and improvements in ability to work. 6 Therefore, belimumab is cost-effective both in terms of employment and in decreasing health resource utilization. 6 Although the approval of belimumab IV was a significant step in improving treatment options for patients with SLE, the IV administration route can pose challenges for some patients.…”

Section: Introductionmentioning

confidence: 99%

“…6 Therefore, belimumab is cost-effective both in terms of employment and in decreasing health resource utilization. 6 Although the approval of belimumab IV was a significant step in improving treatment options for patients with SLE, the IV administration route can pose challenges for some patients. Belimumab IV must be administered at a clinic or infusion centre, which is resource-intensive for the healthcare system and time-consuming for patients.…”

Section: Introductionmentioning

confidence: 99%

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A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus

Doria

Bass

Schwarting

et al. 2018

Lupus

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ObjectiveTo evaluate the safety, tolerability and efficacy of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE) beyond 1 year.MethodsThis was a 24-week, open-label extension following a 52-week, double-blind, placebo-controlled trial of belimumab SC. Patients who completed the double-blind phase were eligible to enter the open-label phase. All patients received weekly belimumab 200 mg SC plus standard SLE therapy. Outcome measures included safety and efficacy (SLE Response Index (SRI) and SLE Flare Index (SFI) rates), and changes in biomarker and B cell levels.ResultsOf 677 patients who completed the 52-week, double-blind phase, 662 entered the open-label phase; 206 had previously received placebo and 456 had previously received belimumab. Despite differences in total belimumab exposure (24 weeks in the placebo-to-belimumab group versus 76 weeks in the belimumab group), the proportions of patients experiencing more than one adverse event (AE) or a serious AE in the open-label phase were similar between groups (placebo-to-belimumab: 51.5 and 6.8%; belimumab: 48.2 and 5.5%, respectively). Most AEs were mild/moderate in severity. Efficacy was maintained through the extension phase. An SRI response was achieved by 16.1% of patients in the placebo-to-belimumab group and 76.3% patients in the belimumab group. Furthermore, 1.0% of patients in the placebo-to-belimumab group and 2.6% of patients in the belimumab group experienced a severe SFI flare.ConclusionBelimumab SC was well tolerated and efficacy was maintained during the extension phase of this study. The safety profile of belimumab SC is consistent with that of previous experience with belimumab.Trial registrationClinicalTrials.gov identifier: NCT01484496

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The potential similarities of COVID-19 and autoimmune disease pathogenesis and therapeutic options: new insights approach

et al. 2020

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Cytokine pathways and their signaling disorders can be the cause of onset and pathogenesis of many diseases such as autoimmune diseases and COVID-19 infection. Autoimmune patients may be at higher risk of developing infection due to the impaired immune responses, the use of immunosuppressive drugs, and damage to various organs. Increased secretion of inflammatory cytokines and intolerance of the patient's immune system to COVID-19 infection are the leading causes of hospitalization of these patients. The content used in this paper has been taken from English language articles (2005-2020) retrieved from the PubMed database and Google Scholar search engine using "COVID-19," "Autoimmune disease," "Therapeutic," "Pathogenesis," and "Pathway" keywords. The emergence of COVID-19 and its association with autoimmune disorders is a major challenge in the management of these diseases. The results showed that the use of corticosteroids in the treatment of autoimmune diseases can make diagnosis and treatment of COVID-19 more challenging by preventing the fever. Due to the common pathogenesis of COVID-19 and autoimmune diseases, the use of autoimmune drugs as a possible treatment option could help control the virus. Key Points • Inflammatory cytokines play an essential role in the pathogenesis of COVID-19 • ACE2 dysfunctions are related to the with COVID-19 and autoimmune diseases • The use autoimmune diseases drugs can be useful in treating COVID-19

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When to use belimumab in SLE

Cited by 16 publications

References 14 publications

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

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

A 6-month open-label extension study of the safety and efficacy of subcutaneous belimumab in patients with systemic lupus erythematosus

The potential similarities of COVID-19 and autoimmune disease pathogenesis and therapeutic options: new insights approach

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