---
title: "Telitacicept for Lupus Nephritis: Real‑World Triple‑Cohort Study — Article Content Not Available"
id: "frontiers-in-immunology-16-a-real-world-triple-cohort-study-on-the-effectiveness-and-safety-of"
canonical_url: "https://medichelpline.com/clinical-feed/frontiers-in-immunology-16-a-real-world-triple-cohort-study-on-the-effectiveness-and-safety-of"
content_type: "clinical_feed_article"
specialty: "Nephrology"
source_name: "Frontiers in Immunology"
source_url: "https://www.frontiersin.org/articles/10.3389/fimmu.2026.1748931"
published_at: "2026-09-16T00:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Telitacicept for Lupus Nephritis: Real‑World Triple‑Cohort Study — Article Content Not Available
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/frontiers-in-immunology-16-a-real-world-triple-cohort-study-on-the-effectiveness-and-safety-of
- **Specialty:** [Nephrology](https://medichelpline.com/clinical-feed/nephrology.md)
- **Primary Source:** Frontiers in Immunology
- **Source URL:** [Original Journal Publication](https://www.frontiersin.org/articles/10.3389/fimmu.2026.1748931)
- **Published At:** 2026-09-16T00:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The source article title indicates a real‑world, triple‑cohort study assessing **telitacicept** in immunosuppressant‑naïve and refractory **lupus nephritis**. The publicly provided page content did not contain the manuscript text or results. - Key items typically expected from such a study—study design details, cohort definitions, sample sizes, baseline characteristics, efficacy endpoints, safety/adverse events, statistical methods and outcomes—were not present in the available source content. - Because the article body and data were not accessible in the source, no factual statements about effectiveness, comparative outcomes, or safety of telitacicept can be reported. - Readers and clinicians should consult the original article PDF or the journal site for complete methods, results, numerical outcomes, and authors’ conclusions before applying findings to clinical care. - The absence of manuscript content on the provided page is a reporting gap; essential data that would inform practice or further research were not retrievable from the supplied source.
## Clinical Analysis & Structured Key Points
Frontiers | A real-world, triple-cohort study on the effectiveness and safety of telitacicept in immunosuppressant-naïve and refractory lupus nephritis ORIGINAL RESEARCH article Front. Immunol. , 16 September 2026 Sec. Multiple Sclerosis and Neuroimmunology Volume 17 - 2026 | https://doi.org/10.3389/fimmu.2026.1748931 Published in Frontiers in Immunology Multiple Sclerosis and Neuroimmunology 7 impact factor 11.3 citescore Part of a Research Topic Therapeutic Agents for Lupus Treatment 36k views 12 articles Editor & Reviewers Edited by M S Muna Saleh Reviewed by E M Enrique Morales A A Andrea Angeletti Outline Figures and Tables Figure 1 View in article Figure 2 View in article Table 1 Baseline characteristics. View in article Table 2 LSM changes in laboratory parameters from baseline to week 48. View in article Table 3 Glucocorticoid dose over time. View in article Table 4 Treatment-emergent adverse events. View in article ORIGINAL RESEARCH article Front. Immunol. , 16 September 2026 Sec. Multiple Sclerosis and Neuroimmunology Volume 17 - 2026 | https://doi.org/10.3389/fimmu.2026.1748931 A real-world, triple-cohort study on the effectiveness and safety of telitacicept in immunosuppressant-naïve and refractory lupus nephritis S L Suren Lai 1 † S L Shanshan Li 2 † J C Jiaying Cai 1 L S Lingyun Sun 1 H H Huasang Huang 1 J W Jie Wang 1 J C Jinhai Chen 3 S S Shizhong Shen 1 * 1. Department of Nephrology, The First Affiliated Hospital of Quanzhou, Fujian Medical University, Quanzhou, China 2. Department of Nephrology, Wenling First People’s Hospital, Wenling, China 3. Department of Nephrology, The Second Affiliated Hospital of Fujian Medical University, Quanzhou, China See more Article metrics View details 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. 1 Introduction Lupus nephritis (LN), a serious and common complication of systemic lupus erythematosus (SLE), affects 40%-60% of patients and remains a major cause of morbidity and mortality. Despite standard-of-care treatment with hydroxychloroquine (HCQ), glucocorticoids (GCs), and immunosuppressants (IS) such as mycophenolate mofetil or cyclophosphamide, or calcineurin inhibitors such as voclosporin, many patients respond inadequately or are intolerant, leading to refractory LN. Additionally, relapse rates stay high (33%-40%) among initial responders, and long-term use of high-dose GCs and IS contributes to significant toxicity ( 1 – 4 ). The crucial role of B cells in SLE development has led to the creation of biologic agents targeting B-cell pathways. Rituximab, an anti-CD20 monoclonal antibody, showed limited success in controlled LN trials, underscoring the difficulties in B-cell targeting ( 5 ). Conversely, belimumab, a monoclonal antibody that blocks the B-cell survival factor BAFF, has proven effective in LN, confirming this pathway as a therapeutic target ( 6 ). However, the concurrent APRIL pathway, which is vital for the survival of long-lived plasma cells, the main producers of autoantibodies, is not affected by belimumab ( 7 ). Telitacicept offers a novel therapeutic approach as a recombinant TACI-Fc fusion protein that simultaneously neutralizes both BAFF and APRIL ( 8 ). This dual-target mechanism allows for more extensive suppression of B-lineage cells, including long-lived plasma cells, potentially providing greater efficacy than agents that target only one molecule ( 9 ). Although telitacicept has demonstrated promise in SLE clinical trials and gained regulatory approval in China, comprehensive real-world data specifically in LN populations, especially when comparing immunosuppressants (IS)-naïve and refractory patients, remains limited ( 10 ). This bicentric, real-world, retrospective, triple-cohort study was designed to address two comparative aims: (1) to compare telitacicept add-on to SOC with SOC alone in the treatment of IS-naïve LN patients; and (2) to compare telitacicept in the treatment of IS-naïve LN versus refractory LN patients. 2 Materials and methods 2.1 Study design and participants This bicentric, retrospective, triple-cohort study was conducted at the Departments of Nephrology at the First and Second Affiliated Hospitals of Fujian Medical University. The inclusion criteria for all participants were: (1) age ≥18 years at the time of confirmed LN diagnosis and meeting the 2019 EULAR/ACR classification criteria for SLE ( 11 ); (2) biopsy-confirmed LN with active lesions; (3) serum positivity for antinuclear antibodies (ANAs) and/or anti–double-stranded DNA (anti-dsDNA) antibodies at the time of the first confirmed LN diagnosis; (4) available Kidney-biopsy LN classification according to the International Society of Nephrology/Renal Pathology Society (ISN/RPS) ( 12 ); (5) a ratio of urinary protein to creatinine (UPCR) > 1.0 g/g (100 mg/mmol) based on a 24-hour urine sample collection; (6) at least 48 weeks of follow-up. Exclusion criteria included: (1) dialysis within 1 year; (2) severe infections or significant cardiopulmonary issues; (3) treatment with rituximab or other B-cell-targeted biologics at any time prior to initiating telitacicept. We screened eligible patients through electronic medical record systems (EMR) at both centers. Eligible patients were included and divided into three cohorts: (1) IS-naïve LN patients who had received only GCs or HCQ prior to receiving telitacicept as an add-on to standard-of-care (SOC) therapy (IS-naïve + Telitacicept, Cohort 1); (2) IS-naïve LN patients who had received only GCs or HCQ prior to receiving SOC alone (IS-naïve + SOC, Cohort 2); (3) Refractory LN patients, defined as those who failed to achieve at least a partial renal response (≥50% reduction in UPCR) despite an appropriate 6-month course of SOC therapy (IS, including MMF, cyclophosphamide, etc.; or calcineurin inhibitors) prior to receiving telitacicept as an add-on to SOC therapy (Refractory + Telitacicept, Cohort 3). Supplementary Table A1 provides a detailed summary of prior IS exposure for this cohort. 2.2 Study objectives This study was designed to achieve two primary objectives: (1) to compare the efficacy and safety of telitacicept add-on to SOC with SOC alone in IS-naïve LN patients (Cohort 1 vs Cohort 2); and (2) to compare the efficacy and safety of telitacicept in IS-naïve LN versus refractory LN patients (Cohort 1 vs Cohort 3). The secondary objective was to assess the safety profile of telitacicept across all treatment cohorts. 2.3 Data collection and outcomes Clinical and laboratory data were systematically collected at baseline (just before the first dose of telitacicept) and then at 4, 12, 24, and 48 weeks from the electronic medical record systems in both centers. The primary efficacy endpoint was the time to complete remission (CR). CR was defined as a urine protein-to-creatinine ratio (UPCR) 0.05 (age: P = 0.085; gender: P = 0.234; eGFR: P = 0.916; UPCR: P = 0.856; C3: P = 0.185; C4: P = 0.066; Activity index: P = 0.136; Chronic index: P = 0.459; glucocorticoid: P = 0.184), indicating that the two cohorts were comparable at baseline. For the comparison between Cohort 1 and Cohort 3, Cohort 3 was well balanced for age and gender. As expected, Cohort 3 had significantly lower eGFR (58.5 vs 86.2 mL/min/1.73m², P = 0.050), higher complement C4 (0.14 vs 0.07 g/L, P = 0.020), higher Chronic index than Cohort 1 (median: 3 vs 1, P = 0.029), and lower baseline glucocorticoid doses (19.2 vs 37.6 mg/d, P = 0.005), reflecting the expected clinical differences between treatment-naïve and refractory populations. 3.2 Renal remission Time-to-CR analysis indicated a numerical advantage for Cohort 1 over Cohorts 2 and 3, though the differences were not statistically significant. The KM curves crossed early. In the comparison between Cohort 1 and Cohort 2, Cox regression showed a hazard ratio (HR) of 1.268 (95% CI: 0.567–2.834, P = 0.578). RMET analysis at τ = 55 weeks showed that Cohort 1 achieved CR on average 3.96 weeks earlier than Cohort 2 (RMET difference: −3.96 weeks; 95% CI: −17.13 to 9.21; P = 0.556) ( Figures 1C, D ). For Cohort 1 vs Cohort 3, Cox regression showed an HR of 1.364 (95% CI: 0.600–3.102; Log-rank P = 0.459). RMET analysis showed that Cohort 1 achieved CR on average 4.89 weeks earlier than Cohort 3 (RMET difference: −4.89 weeks; 95% CI: −18.50 to 8.73; P = 0.482) ( Figures 1C, E ). Figure 1 Renal efficacy outcomes in treatment-naïve and refractory lupus nephritis patients treated with telitacicept. (A) Longitudinal changes in urine protein-to-creatinine ratio (UPCR). (B) Changes in estimated glomerular filtration rate (eGFR). (C) Kaplan-Meier curves for time to complete renal remission. (D) RMET for IS-naïve + Telitacicept cohort vs IS-naïve + SOC cohort. (E) RMET for IS-naïve + Telitacicept cohort vs Refractory+Telitacicept cohort. (F) Complete remission rates at weeks 24 and 48. (G) Total remission rates at weeks 24 and 48. CRR, complete renal remission. HR, Hazard ratio. CI, confidence interval. Cohort 1, IS-naïve + Telitacicept (n = 16). Cohort 2, IS-naïve + SOC (n = 22). Cohort 3, Refractory+Telitacicept (n = 17). RMET, restricted mean event time. **** P < 0.0001, *** P < 0.001, ** P < 0.01, * P < 0.05, ns, not significant. a, p-value within the cohort. b, p-value between cohorts 1 and 2. c, p-value between cohorts 1 and 3. CR rates improved steadily over the 48-week study period across the three cohorts. Cohort 1 had slightly higher CR rates at weeks 24 (56.2%) and 48 (68.8%), and these trends were consistent with TR rates, except that Cohort 2 showed a slightly higher TR rate (90.9%) at week 24 ( Figures 1F, G ). No statistically significant differences were observed between Cohorts 1 and 2 or 3 in CR or TR rates. 3.3 Changes from baseline of laboratory parameters Supplementary Table A4 ; Table 2 and Figures 1 , 2 present least squares mean (LSM) changes from baseline to Weeks 24 and 48 for key laboratory parameters. Cohort 1 showed the greatest LSM improvement in eGFR from baseline to Week 48 (+23.4 mL/min/1.73m², 95% CI: 13.3–33.4), compared with Cohort 2 (+8.5 mL/min/1.73m², 95% CI: −0.5 to 17.5) and Cohort 3 (+2.8 mL/min/1.73m², 95% CI: −7.6 to 13.3). Between-cohort differences were statistically significant between Cohort 1 and Cohort 2 (P = 0.03) and between Cohort 1 and Cohort 3 (P = 0.007) ( Supplementary Table A4 ; Table 2 ; Figure 1A ). All three cohorts showed substantial reductions in UPCR, with LSM changes of −392.7 mg/mmol (95% CI: −464.5 to −320.9) in Cohort 1, −382.7 mg/mmol (95% CI: −444.0 to −321.4) in Cohort 2, and −337.9 mg/mmol (95% CI: −407.7 to −268.1) in Cohort 3. Within-cohort P values were < 0.0001. No significant between-cohort differences were observed (Cohort 1 vs Cohort 2: P = 0.83; Cohort 1 vs Cohort 3: P = 0.28) ( Supplementary Tables A4 ; Table 2 ; Figure 1B ). Table 2 Measures LSM change from baseline (95% CI) † p value A. Cohort 1 (N = 16) B. Cohort 2 (N = 22) C. Cohort 3 (n=17) A vs B A vs C eGFR (mL/min/1.73m²) 23.4 (13.3, 33.4) **** 8.5 (-0.5, 17.5) ns 2.8 (-7.6, 13.3) ns 0.030 0.007 UPCR (mg/mmol) -392.71 (-464.5, -320.92) **** -382.68 (-444, -321.37) **** -337.92 (-407.73, -268.11) **** 0.83 0.28 C3 (g/L) 0.40 (0.3, 0.5) **** 0.31 (0.24, 0.39) **** 0.35 (0.26, 0.43) **** 0.16 0.44 C4 (g/L) 0.07 (0.03, 0.11) ** 0.12 (0.09, 0.16) **** 0.11 (0.07, 0.15) **** 0.05 0.20 IgA (g/L) -1.22 (-1.91, -0.54) *** -0.73 (-1.24, -0.22) ** -1.09 (-1.69, -0.48) *** 0.25 0.77 IgG (g/L) -2.13 (-3.75, -0.52) * -0.92 (-2.16, 0.32) ns -2.87 (-4.28, -1.46) *** 0.24 0.49 IgM (g/L) -0.81 (-1.02, -0.61) **** -0.41 (-0.57, -0.26) **** -0.82 (-1, -0.64) **** 0.002 0.980 Serum Albumin (g/L) 15.64 (13.78, 17.51) **** 12.08 (10.5, 13.65) **** 12.76 (10.92, 14.61) **** 0.005 0.040 Hb (g/L) 28.59 (22.83, 34.34) **** 14.83 (9.86, 19.8) **** 13.14 (7.55, 18.72) **** 0.0007 0.0003 BPC (×10 9 /L) 54.39 (27.52, 81.25) *** 27.61 (5.15, 50.08) * 37.37 (11.41, 63.33) ** 0.13 0.37 LSM changes in laboratory parameters from baseline to week 48. LSM, least squares mean. C3, C4, complement C3, C4. Ig, immunoglobulin. BPC, blood platelet count. † Indic
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