Potential and prognostic factor for belimumab-free remission in patients with systemic lupus erythematosus: a single-center retrospective analysis

• Published in: Clinical rheumatology 2020-12, Vol.39 (12), p.3653-3659
• Main Authors: Nakai, Takehiro, Fukui, Sho, Ikeda, Yukihiko, Shimizu, Hisanori, Tamaki, Hiromichi, Okada, Masato
• Format: Article
• Language: English
• Subjects: Anti-DNA antibodies; Antibodies, Monoclonal, Humanized; Brief Report; Complement component C3; Complement component C4; Electronic medical records; Humans; Immunosuppressive agents; Immunosuppressive Agents - therapeutic use; Lupus; Lupus Erythematosus, Systemic - drug therapy; Medicine; Medicine & Public Health; Monoclonal antibodies; Prednisolone; Prognosis; Remission; Retrospective Studies; Rheumatology; Severity of Illness Index; Systemic lupus erythematosus; Treatment Outcome
• ISSN: 0770-3198; 1434-9949
• DOI: 10.1007/s10067-020-05052-0

Belimumab is an effective and safe treatment option for systemic lupus erythematosus (SLE). However, data on treatment cessation are lacking. Thus, we investigated belimumab-free remission in SLE patients. SLE patients receiving belimumab in our institute (May 1, 2013–May 31, 2019) were retrospectively identified using electronic health records. Eligibility criteria included receiving belimumab for > 180 days and discontinuation for any reason. BILAG category A or B in at least one organ system indicated a disease flare. Follow-up monitoring during post-treatment at week 52 identified relapse-free and relapse patients. Thirty-one patients received belimumab, and 8 patients were included. Of the 8 patients, 4 relapsed within 52 weeks. At belimumab discontinuation, relapse-free patients achieved lower SELENA-SLEDAI (1 [IQR, 0–2] vs. 7 [IQR, 5.5–8] ( p  = 0.03)), received significantly less steroid (prednisolone equivalent, 3.0 mg/day [IQR, 2.8–3.2] vs. 9.5 mg/day [IQR, 7.3–13.3], p  = 0.02) than relapse patients, and significantly more relapse-free patients achieved SELENA-SLEDAI less than 4 and received prednisolone less than 5 mg/day than relapse patients. Furthermore, on discontinuation day, relapse-free patients tended to have higher C3 (91.0 mg/dL [IQR, 78.8–102.3] vs. 56.0 mg/dL [IQR, 39.8–73.0], p  = 0.15) and C4 levels (22.0 mg/dL [IQR, 19.00–26.00] vs. 11.0 mg/dL [IQR, 6.00–16.00], p  = 0.08) and less anti-dsDNA antibody (5.2 IU/mL [IQR, 3.8–7.8] vs. 48.0 IU/mL [IQR, 11.5–137.3], p  = 0.08) than relapse patients. Belimumab discontinuation can be considered for patients who achieved good responses. Normalization of complement, anti-dsDNA antibody, SELENA-SLEDAI less than 4, and steroid dosage less than 5 mg/day might be prognostic markers for belimumab-free remission.