Background/Purpose: Belimumab is the first biologic drug approved to treat Systemic Lupus Erythematosus (SLE). The efficacy of belimumab has been demonstrated through 2 phase III clinical trials. Real-life experiences are anticipated in order to form an opinion of how belimumab is used in clinical praxis and provide guidance for improvements in its future use. We investigated the clinical effects of belimumab in patients with active SLE despite standard of care therapy.

Methods: Fifty-two patients from Karolinska (n=25), Skåne (n=19), and Linköping (n=8) University Hospitals treated with belimumab were enrolled in this study and followed longitudinally. Global disease activity was assessed using the SLE Disease Activity Index 2000 (SLEDAI-2K), Systemic Lupus Activity Measure-Revised (SLAM-R), and a 100 mm Visual Analogue Scale (VAS) for Physician’s Global Assessment (PGA). Organ damage was evaluated according to the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI). Quality of Life (QoL) was evaluated by patients’ reports for pain, fatigue and well-being levels using 100 mm Visual Analogue Scales. Global health outcome was determined by the EuroQol Research Foundation 5 Dimension (EQ-5D) health questionnaire, scored according to the UK tariff. Functional status was assessed using the Stanford Health Assessment Questionnaire (HAQ) functional disability index.

Results: Belimumab was mainly given for musculoskeletal (n=24), mucocutaneous (n=24), hematological (n=10), renal (n=5), respiratory (n=4), and neurological (n=3) manifestations.

Significant decreases over time were observed for SLEDAI-2K (median baseline score: 7; range: 2–24; p<0.001), corresponding to a decrease of 3.42 over a year, SLAM-R (median baseline score: 13; range: 5–26; p<0.001) and PGA (p<0.001). We also observed decreases of prednisone equivalent dosages (mean baseline dose: 12.3 mg/day; range: 0–60 mg/day; p<0.001), corresponding to a decrease of 4.93 mg/day over a year. C4 levels increased significantly (p=0.006), but C3 levels remained unchanged. We observed significant improvements in well-being (p<0.001), pain (p<0.001) and fatigue (p=0.018), but no significant changes in HAQ and no significant improvements in EQ-5D. SDI scores remained stable.

Reasons for discontinuation included inadequate or uncertain effect (n=7), flare (n=5: increased proteinuria; arthritis, headache; rash, alopecia; biopsy-proven lupus nephritis WHO class III; CNS-lupus), adverse events (n=3: acute myeloid leukemia; ground glass opacity in computed tomography scan of the lungs, pulmonary arterial hypertension; insomnia, arrhythmia), allergic reactions (n=2) and pregnancy plans (n=2).

Conclusion: In this real-life observational study, belimumab treatment decreased disease activity, reduced corticosteroid usage and improved the patients’ quality of life in terms of pain, fatigue and well-being over time, but had no significant effects on their functional status. There was no progression of organ damage during the follow-up. The tolerability and safety profiles of belimumab in this study were comparable with those in previous reports from the phase III trials.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/decreased-disease-activity-and-corticosteroid-usage-and-improved-quality-of-life-during-belimumab-treatment-in-patients-with-systemic-lupus-erythematosus-ae-a-prospective-real-life-observatio/