Effects of Belimumab on Flare Rate and Expected Damage Progression in Patients With Active Systemic Lupus Erythematosus

Abstract

Objective. To investigate effectiveness and safety of belimumab in patients with active systemic lupus erythematosus (SLE) in a clinical practice setting. Methods. Sixty-seven patients with active SLE, mean 6 SD age 39.3 6 10.2 years, from 2 Italian prospective cohorts were treated with belimumab (10 mg/kg on day 0, 14, 28, and then every 28 days) added to background therapy. The Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), the Systemic Lupus International Collaborating Clinics/ American College of Rheumatology Damage Index, the Disease Activity Score in 28 joints (DAS28), 24-hour proteinuria, the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score, anti-double-stranded DNA (antidsDNA), C3 and C4 levels, and prednisone daily dose were recorded at baseline, month 3, 6, 9, 12, 18, and 24. Arthritis was subdivided into "classical" (CLP) and "rheumatoid-like"; skin manifestations into acute (ACLE), subacute (SCLE), and chronic. SLE flares, defined according to the SLEDAI Flare Index, were calculated before and after belimumab initiation. Adverse events were carefully evaluated during treatment. Statistics were performed by the SPSS package (version 21.0). Results. Mean 6 SD followup was 16.2 6 9.5 months. Main refractory manifestations treated with belimumab were musculoskeletal (37.3%), mucocutaneous (22.4%), and renal (23.9%). SLEDAI-2K, prednisone daily dose, anti-dsDNA, DAS28, CLASI, and 24-hour proteinuria decreased during treatment. DAS28 score decreased in patients with polyarthritis (P < 0.001), particularly in those with CLP (P < 0.001), and CLASI decreased in patients with skin manifestation (P 5 0.003), either ACLE (P 5 0.051) or SCLE (P 5 0.047). Flare rate was lower 1 and 2 years after belimumab initiation than in the periods before (P 5 0.001). Belimumab was well-tolerated and no damage accrual was observed after initiation. Conclusion. Belimumab was effective and safe in a clinical practice setting; it decreased the number of flares and hindered damage progression in patients with active SLE.

Effect of Belimumab on the Cutaneous Manifestations of Patients With Lupus Erythematosus

“…Overall, we observed a continuous and significant response of cutaneous lupus lesions under belimumab treatment. This finding aligns with previous reports demonstrating a decrease in CLASI and RCLASI activity scores after three and 6 months [13]. Iaccarino et al.…”

“…Overall, we observed a continuous and significant response of cutaneous lupus lesions under belimumab treatment. This finding aligns with previous reports demonstrating a decrease in CLASI and RCLASI activity scores after three and 6 months [13]. Iaccarino et al also performed an analysis of the response in CLE subtypes and showed a significant reduction of the CLASI activity score in patients with ACLE and SCLE during treatment with belimumab.…”

Effect of Belimumab on the Cutaneous Manifestations of Patients With Lupus Erythematosus

“…Overall, we observed a continuous and significant response of cutaneous lupus lesions under belimumab treatment. This finding aligns with previous reports demonstrating a decrease in CLASI and RCLASI activity scores after three and 6 months [13]. Iaccarino et al.…”

“…Overall, we observed a continuous and significant response of cutaneous lupus lesions under belimumab treatment. This finding aligns with previous reports demonstrating a decrease in CLASI and RCLASI activity scores after three and 6 months [13]. Iaccarino et al also performed an analysis of the response in CLE subtypes and showed a significant reduction of the CLASI activity score in patients with ACLE and SCLE during treatment with belimumab.…”

Early and Late Response and Glucocorticoid-Sparing Effect of Belimumab in Patients with Systemic Lupus Erythematosus with Joint and Skin Manifestations: Results from the Belimumab in Real Life Setting Study—Joint and Skin (BeRLiSS-JS)

“…In our multivariate models, a short disease duration and a lower DAS28 or CLASI at baseline predicted DAS28 and CLASI remission or LDA during the follow-up, suggesting that the earlier the use of belimumab, the better the outcome, regardless of the organspecific activity score used to quantify organ-specific activity. In fact, this is in line with our previous studies, which demonstrated that the use of belimumab in the early stage of the disease was associated with a better SRI-4 response and damage prevention [5,11,12].…”

Smoking reduces the efficacy of belimumab in mucocutaneous lupus

“…The documentation of efficacy of belimumab in mucocutaneous and articular manifestations in patients with SLE is not novel. Post-hoc analyses from randomized clinical trials of belimumab have shown that patients with these manifestations are more likely to respond to belimumab treatment [22], and consistent real-life experiences have also been reported [37,44]. In the present study, we corroborated previous findings, and also showed that tobacco smoking may negatively impact the efficacy of belimumab on mucocutaneous manifestations.…”

Effect of Belimumab on the Cutaneous Manifestations of Patients With Lupus Erythematosus

“…Overall, we observed a continuous and significant response of cutaneous lupus lesions under belimumab treatment. This finding aligns with previous reports demonstrating a decrease in CLASI and RCLASI activity scores after three and 6 months [13]. Iaccarino et al.…”

“…Overall, we observed a continuous and significant response of cutaneous lupus lesions under belimumab treatment. This finding aligns with previous reports demonstrating a decrease in CLASI and RCLASI activity scores after three and 6 months [13]. Iaccarino et al also performed an analysis of the response in CLE subtypes and showed a significant reduction of the CLASI activity score in patients with ACLE and SCLE during treatment with belimumab.…”

Early and Late Response and Glucocorticoid-Sparing Effect of Belimumab in Patients with Systemic Lupus Erythematosus with Joint and Skin Manifestations: Results from the Belimumab in Real Life Setting Study—Joint and Skin (BeRLiSS-JS)

“…In our multivariate models, a short disease duration and a lower DAS28 or CLASI at baseline predicted DAS28 and CLASI remission or LDA during the follow-up, suggesting that the earlier the use of belimumab, the better the outcome, regardless of the organspecific activity score used to quantify organ-specific activity. In fact, this is in line with our previous studies, which demonstrated that the use of belimumab in the early stage of the disease was associated with a better SRI-4 response and damage prevention [5,11,12].…”

Smoking reduces the efficacy of belimumab in mucocutaneous lupus

“…The documentation of efficacy of belimumab in mucocutaneous and articular manifestations in patients with SLE is not novel. Post-hoc analyses from randomized clinical trials of belimumab have shown that patients with these manifestations are more likely to respond to belimumab treatment [22], and consistent real-life experiences have also been reported [37,44]. In the present study, we corroborated previous findings, and also showed that tobacco smoking may negatively impact the efficacy of belimumab on mucocutaneous manifestations.…”

Effect of Belimumab on the Cutaneous Manifestations of Patients With Lupus Erythematosus

“…Overall, we observed a continuous and significant response of cutaneous lupus lesions under belimumab treatment. This finding aligns with previous reports demonstrating a decrease in CLASI and RCLASI activity scores after three and 6 months [13]. Iaccarino et al.…”

“…Overall, we observed a continuous and significant response of cutaneous lupus lesions under belimumab treatment. This finding aligns with previous reports demonstrating a decrease in CLASI and RCLASI activity scores after three and 6 months [13]. Iaccarino et al also performed an analysis of the response in CLE subtypes and showed a significant reduction of the CLASI activity score in patients with ACLE and SCLE during treatment with belimumab.…”

Early and Late Response and Glucocorticoid-Sparing Effect of Belimumab in Patients with Systemic Lupus Erythematosus with Joint and Skin Manifestations: Results from the Belimumab in Real Life Setting Study—Joint and Skin (BeRLiSS-JS)

“…In our multivariate models, a short disease duration and a lower DAS28 or CLASI at baseline predicted DAS28 and CLASI remission or LDA during the follow-up, suggesting that the earlier the use of belimumab, the better the outcome, regardless of the organspecific activity score used to quantify organ-specific activity. In fact, this is in line with our previous studies, which demonstrated that the use of belimumab in the early stage of the disease was associated with a better SRI-4 response and damage prevention [5,11,12].…”

Smoking reduces the efficacy of belimumab in mucocutaneous lupus

“…The documentation of efficacy of belimumab in mucocutaneous and articular manifestations in patients with SLE is not novel. Post-hoc analyses from randomized clinical trials of belimumab have shown that patients with these manifestations are more likely to respond to belimumab treatment [22], and consistent real-life experiences have also been reported [37,44]. In the present study, we corroborated previous findings, and also showed that tobacco smoking may negatively impact the efficacy of belimumab on mucocutaneous manifestations.…”