<HashMap><database>biostudies-literature</database><scores/><additional><omics_type>Unknown</omics_type><volume>5(4)</volume><submitter>Ji L</submitter><pubmed_abstract>Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease associated with B-cell hyperactivity. Telitacicept is a transmembrane activator, calcium modulator, and cyclophilin ligand interactor-Fc fusion protein, which can neutralize both B-cell lymphocyte stimulator and a proliferation-inducing ligand. Patients with active SLE who received telitacicept were prospectively followed at month 1, 3, 6, 9, and 12 after telitacicept initiation. Thirty-seven participants were involved and followed for 6.00 [3.00, 6.00] months. SRI-4 rate at month 6 was 44.7%. The median dosage of prednisone was decreased by 43.8% (from 10 to 5.62 mg/d) at month 6. The anti-dsDNA level was significantly decreased, while complement levels were significantly increased at month 6 from baseline. Continuously significant reductions in serum immunoglobin (Ig)G IgA, and IgM levels were also observed. Patients experienced significant decreases in the numbers of total and naive B cells, whereas memory B cells and T cell populations did not change. The number of NK cells was significantly increased during the follow-up. At month 6, 58.3% (14 out of 24) patients experienced improved fatigue accessed by FACIT-Fatigue score exceeding the minimum clinically important difference of 4. Most adverse events were mild, but one each case of severe hypogammaglobulinemia, psychosis with suicidal behavior, and B-cell lymphoma were occurred. In our first prospective real-world study, telitacicept treatment led to a significant clinical and laboratory improvement of disease activity, as well as fatigue amelioration in patients with SLE. Safety profile was favorable overall, but more studies are greatly needed.</pubmed_abstract><journal>MedComm</journal><pagination>e515</pagination><full_dataset_link>https://www.ebi.ac.uk/biostudies/studies/S-EPMC10960726</full_dataset_link><repository>biostudies-literature</repository><pubmed_title>B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single-arm cohort study of telitacicept.</pubmed_title><pmcid>PMC10960726</pmcid><pubmed_authors>Qu C</pubmed_authors><pubmed_authors>Tan M</pubmed_authors><pubmed_authors>Zhang Z</pubmed_authors><pubmed_authors>Zhang X</pubmed_authors><pubmed_authors>Tan Y</pubmed_authors><pubmed_authors>Ji L</pubmed_authors><pubmed_authors>Geng Y</pubmed_authors><pubmed_authors>Deng X</pubmed_authors><pubmed_authors>Song Z</pubmed_authors></additional><is_claimable>false</is_claimable><name>B cell pathway dual inhibition for systemic lupus erythematosus: a prospective single-arm cohort study of telitacicept.</name><description>Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease associated with B-cell hyperactivity. Telitacicept is a transmembrane activator, calcium modulator, and cyclophilin ligand interactor-Fc fusion protein, which can neutralize both B-cell lymphocyte stimulator and a proliferation-inducing ligand. Patients with active SLE who received telitacicept were prospectively followed at month 1, 3, 6, 9, and 12 after telitacicept initiation. Thirty-seven participants were involved and followed for 6.00 [3.00, 6.00] months. SRI-4 rate at month 6 was 44.7%. The median dosage of prednisone was decreased by 43.8% (from 10 to 5.62 mg/d) at month 6. The anti-dsDNA level was significantly decreased, while complement levels were significantly increased at month 6 from baseline. Continuously significant reductions in serum immunoglobin (Ig)G IgA, and IgM levels were also observed. Patients experienced significant decreases in the numbers of total and naive B cells, whereas memory B cells and T cell populations did not change. The number of NK cells was significantly increased during the follow-up. At month 6, 58.3% (14 out of 24) patients experienced improved fatigue accessed by FACIT-Fatigue score exceeding the minimum clinically important difference of 4. Most adverse events were mild, but one each case of severe hypogammaglobulinemia, psychosis with suicidal behavior, and B-cell lymphoma were occurred. In our first prospective real-world study, telitacicept treatment led to a significant clinical and laboratory improvement of disease activity, as well as fatigue amelioration in patients with SLE. Safety profile was favorable overall, but more studies are greatly needed.</description><dates><release>2024-01-01T00:00:00Z</release><publication>2024 Apr</publication><modification>2025-04-26T12:05:59.263Z</modification><creation>2025-04-06T13:53:10.304Z</creation></dates><accession>S-EPMC10960726</accession><cross_references><pubmed>38525109</pubmed><doi>10.1002/mco2.515</doi></cross_references></HashMap>