Safety and efficacy of biological agents in the treatment of Systemic Lupus Erythematosus (SLE)

Justin Chan; Giles D Walters; Prianka Puri; Simon H Jiang

doi:10.1186/s41927-023-00358-3

Safety and efficacy of biological agents in the treatment of Systemic Lupus Erythematosus (SLE)

BMC Rheumatol. 2023 Oct 9;7(1):37. doi: 10.1186/s41927-023-00358-3.

Authors

Justin Chan^{1

2}, Giles D Walters^{3

4}, Prianka Puri⁵, Simon H Jiang^{3

4}

Affiliations

¹ John Curtin School of Medical Research, Australian National University, Canberra, Australian Capital Territory, Australia. justinhlchan@outlook.com.
² Department of Renal Medicine, Canberra Hospital, Canberra, Australian Capital Territory, Australia. justinhlchan@outlook.com.
³ John Curtin School of Medical Research, Australian National University, Canberra, Australian Capital Territory, Australia.
⁴ Department of Renal Medicine, Canberra Hospital, Canberra, Australian Capital Territory, Australia.
⁵ Department of Nephrology, Royal Brisbane and Woman's Hospital Health Service District, Herston, QLD, Australia.

Abstract

Background: To determine the safety and efficacy of biological agents used in the treatment of systemic lupus erythematosus (SLE) in adults.

Methods: Systematic review and meta-analysis following PRISMA guidelines.

Data sources: MEDLINE (through Pubmed), EMBASE, Cochrane library, Clinicaltrials.gov, Australianclinicaltrials.gov.au, ANZCTR.org.au and WHO International Clinical Trials Registry Platform for studies published from 20 May 2021 and 15 years prior. A grey literature search was performed and completed on 31 May 2021.

Study criteria: Phase II, III or quasi randomised controlled trials, studies with only cerebral or cutaneous lupus were excluded.

Data extraction: Two authors independently screened studies for eligibility, extracted, reviewed data for accuracy, and used the Cochrane tool to assess risk of bias.

Results: Forty-four studies were identified, consisting of 15 groups of drugs and 25 different biological agents, totalling 16,889 patients. The main outcomes assessed included Systemic Lupus Erythematosus Responder Index (SRI), BILAG-Based Composite Lupus Assessment (BICLA) and combined combined/partial renal remission (CRR/PRR). Four groups of biologics were found to improve outcomes. Anti-interferons: Anifrolumab increased BICLA response and SRI 5 to 8, decreased prednisone dosages, with increased herpes zoster infections, but fewer serious adverse events. Sifalimumab improved SRI but also increased herpes zoster infections. Anti BAFF/BLyS and/or APRIL: Belimumab consistently improved SRI 4, decreased prednisone dosages, increased combined CRR/PRR, and had no adverse safety outcomes. Tabalumab increased SRI 5 at 52 weeks with no steroid sparing effect but was associated with increased infusion related adverse events. Telitacicept improved SRI 4 at 52 weeks, with no increased adverse events, though data was rather sparse. Anti CD-20 monoclonal antibody, Obinutuzumab increased combined CRR/PRR at 1 and 2 years. Anti IL12/23 monoclonal antibody, Ustekinumab, increased SRI 4 to 6, but not BICLA at 24 weeks, with no concerning safety outcomes.

Conclusion: Multiple biologic agents are shown in high quality studies to have a significant therapeutic impact on outcomes in SLE.

Keywords: Biologics; Renal lupus; Systemic lupus erythematosus.