Evidence map›Paper›PMID 42833728›Full record

ArticleLupus science & medicine2026

Belimumab prevention against organ damage over 8 years and safety up to 13 years: three pooled open-label, long-term extension SLE studies.

Zahi Touma, Cristina Arriens, Maria G Tektonidou, Ricard Cervera, Roger A Levy, Anne Hammer, Daniel J Wallace

Abstract read
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Article in Lupus science & medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

7 authors.

Zahi ToumaDivision of Rheumatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada.ORCID http://orcid.org/0000-0001-5177-2076
Cristina ArriensDepartment of Arthritis and Clinical Immunology, Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.ORCID http://orcid.org/0000-0002-9546-1664
Maria G TektonidouRheumatology Unit, First Department of Propaedeutic Internal Medicine, Laiko Hospital, Medical School, National and Kapodistrian University of Athens, Athens, Greece.ORCID http://orcid.org/0000-0003-2238-0975
Ricard CerveraDepartment of Autoimmune Diseases, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain.
Roger A LevyGlobal Medical Affairs, GSK, Collegeville, Pennsylvania, USA roger.x.levy@gsk.com.ORCID http://orcid.org/0000-0001-6393-6031
Anne HammerImmunology Biostatistics, GSK, Collegeville, Pennsylvania, USA.
Daniel J WallaceDivision of Rheumatology, Cedars-Sinai Medical Center, Los Angeles, California, USA.ORCID http://orcid.org/0000-0002-2502-1372

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveExamine long-term glucocorticoid usage, safety and prevention of organ damage in patients with SLE treated with belimumab plus standard therapy (ST).

methodsThis

resultsAltogether, 1304 patients enrolled in the LTE studies; 1299 received ≥1 dose of belimumab and were included in the modified intent to treat population. Of these, 1221 (94%) patients were female and at enrolment had a mean (SD) age and disease duration of 39.7 (11.6) and 7.2 (6.7) years, respectively. Mean (SD) baseline Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI) and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) scores were 8.2 (4.3) and 0.7 (1.2), respectively. The most frequently used SLE concomitant medications at any time after first dose of belimumab were glucocorticoid (GC) (94.1%), antimalarials (74.6%) and immunosuppressants (56.4%). Approximately 50% of patients reduced their GC dose to ≤7.5 mg/day in the first 3 years, increasing to 73.6% by the end of year 8. Mean (SD) changes in SDI score to year 8 did not exceed 0.3 (0.6). Overall, 97.5% of patients had ≥1 adverse event (AE) up to 13 years. While 40.4% had ≥1 serious AE, the incidence of AEs leading to belimumab discontinuation generally remained low over time (10.7%).

conclusionsPatients with SLE treated with belimumab reduced GC use and had minimal to no organ damage progression over 8 years. Robust and consistent safety data up to 13 years support the well-established favourable safety profile of belimumab, with no new safety concerns.

Indexed as

Antibodies, Monoclonal, HumanizedGlucocorticoidsImmunosuppressive AgentsLupus Erythematosus, SystemicAdultDrug Therapy, CombinationFemaleHumansMaleMiddle AgedTreatment OutcomeAntibodies, Monoclonal, HumanizedbelimumabGlucocorticoidsImmunosuppressive AgentsBiological ProductsClinical TrialGlucocorticoidsLupus Erythematosus, SystemicOutcome Assessment, Health Care

Identifiers

PMID42833728
PMCPMC13646960

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.