ArticleFrontiers in immunology2026
A real-world, triple-cohort study on the effectiveness and safety of telitacicept in immunosuppressant-naïve and refractory lupus nephritis.
Article in Frontiers in immunology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objective: To compare the efficacy and safety of telitacicept as add-on therapy versus standard of care (SOC) alone in immunosuppressant (IS)-naïve patients with lupus nephritis (LN) and in patients with refractory LN. Methods: In this bicentric, real-world, retrospective, triple-cohort study, we enrolled IS-naïve LN patients receiving add-on telitacicept (Cohort 1), IS-naïve LN patients receiving SOC alone (Cohort 2), and refractory LN patients receiving add-on telitacicept (Cohort 3). The primary endpoint was time to complete remission (CR). Secondary endpoints included renal remission rates at weeks 24 and 48, changes in serological and renal function parameters, glucocorticoid reduction, and safety. We assessed time to CR using the Kaplan-Meier (KM) method, Cox regression, and restricted mean event time (RMET) analysis if KM curves crossed early. Least squares mean (LSM) changes were estimated. Results: We enrolled 55 eligible patients. Patients in Cohorts 1 (N = 16) and 3 (N = 17) received telitacicept 160 mg subcutaneously weekly in addition to SOC therapy; those in Cohort 2 (N = 22) received SOC alone. SOC regimens were predominantly mycophenolate mofetil-based. In IS-naïve patients, Cohort 1 achieved CR numerically faster than Cohort 2 (HR = 1.268, 95% CI: 0.567-2.834, P = 0.578; RMET difference: -3.96 weeks, 95% CI: -17.13 to 9.21, P = 0.556). Among patients receiving telitacicept, Cohort 1 showed numerically higher CR (75.0% vs 64.7%) and TR rates (93.8% vs 76.5%) than Cohort 3, with numerically faster CR achievement (HR = 1.364, 95% CI: 0.600-3.102; RMET difference: -4.89 weeks; 95% CI: -18.50 to 8.73). Both telitacicept-treated cohorts showed substantial laboratory improvements, with Cohort 1 demonstrating the greatest eGFR improvement (+23.4 mL/min/1.73m²). A glucocorticoid-sparing effect was observed. Infections were the most common TEAEs; all were mild to moderate. Conclusion: Telitacicept demonstrated favorable efficacy and manageable safety in both IS-naïve and refractory LN patients. In the treatment-naïve setting, telitacicept achieved CR more quickly than SOC. Faster, higher responses in IS-naïve versus refractory patients suggest a potential benefit of early intervention. These findings support early use of telitacicept and underscore the need for larger randomized controlled trials to confirm the benefits of early dual-target B-cell therapy in LN.
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