OBJECTIVE To evaluate the efficacy and safety of biologics in the treatment of systemic lupus erythematosus(SLE).
METHODS The databases of CNKI, Wanfang, PubMed, EMB and Cochrane Library were searched, and the search time limit was from the construction of each database to April 1, 2024, to obtain randomized controlled trials(RCTs) using biologics for the treatment of SLE. After 2 investigators independently screened the literature, extracted the data, and evaluated the included literature, Bayesian network meta-analysis was performed using R 4.2.3.
RESULTS A total of 27 studies including 12955 patients were selected, 14 pharmacologic interventions were included. Network meta-analysis showed that in improving the SRI-4 response rate, Belimumab, Anifrolumab, Tabalumab and Telitacicept were more effective than the placebo group, and the effect of Telitacicept was better than the other drugs(P<0.05); according to the SUCRA values, the top-ranked drug was Telitacicept(0.99). In terms of improving SRI-6 response rate, the effect of Telitacicept was better than that of the placebo group(P<0.05), and the difference between the two comparisons of the rest of the drugs was not statistically significant(P>0.05); according to the SUCRA values, the top-ranked drug was Telitacicept(0.95). In terms of improving the BICLA response rate, Anifrolumab was superior to placebo(P<0.05); according to the SUCRA values, the top-ranked drug was Anifrolumab(0.87). There was no significant difference between the two comparisons of each drug in terms of improving the complete renal response rate(P>0.05); according to the SUCRA values, the top-ranked drug was Obinutuzumab(0.81). The effect of Belimumab and Anifrolumab was better than that of the placebo control group in improving the steroid reduction rate (P<0.05); according to the SUCRA values, the top-ranked drug was Anifrolumab(0.80). In terms of the incidence of adverse reactions, Anifrolumab had a higher risk of occurrence than placebo, Belimumab, PF-04236921, Blisibimod, Epratuzumab, Tabalumab, and Ocrelizumab(P<0.05), and Telitacicept had a higher risk than placebo, Belimumab, PF-04236921, and Ocrelizumab(P<0.05), and Atacicept over PF-04236921. Because the lower the risk of adverse reactions, the better the safety, so the lower the SUCRA value, the better the safety of the drug. According to the SUCRA values, the top-ranked drug of the incidence of adverse reaction was Ocrelizumab(0.17).
CONCLUSIONS Based on the results of the study, Telitacicept has advantages in improving SRI-4 and SRI-6 response rate, but more high-quality studies are needed to validate its safety; Anifrolumab has advantages in improving BICLA response rate and steroid reduction rate; and Ocrelizumab is more advantageous in improving the rate of complete renal response rate. However, due to study limitations, the above conclusions need to be further validated by more high-quality, multicenter RCTs.