The efficacy and safety of combination treatment with rituximab plus telitacicept in patients with antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) are currently being evaluated in the phase 4 TTCAAVREM study.

TTCAAVREM is a prospective, randomized, single-blinded, placebo-controlled, open-label, single-center clinical study sponsored by the Chinese SLE [systemic lupus erythematosus] Treatment and Research Group of Peking Union Medical College Hospital. The investigators of TTCAAVREM are seeking to assess the remission rate among patients with AAV who receive treatment with telitacicept combined with rituximab for the induction of remission and telitacicept alone for the maintenance of remission.

In individuals with AAV, the “basic theme” of the disorder is “relapse and remission.” Among patients with the disorder, maintenance therapy intended to reduce or prevent disease relapse presents significant challenges. The B-cell-activating factor/proliferation inducing ligand (BAFF/APRIL) dual-target inhibitor telitacicept, which has demonstrated effectiveness in the treatment of patients with SLE, has not yet been evaluated for use in patients with AAV. To date, no studies have been conducted in China to investigate the effectiveness of telitacicept for reducing relapses in patients with AAV.

The estimated enrollment in TTCAAVREM is 40 participants with active AAV, who will be assigned to 1 of 2 treatment groups:

  • Telitacicept treatment arm
    • Rituximab plus glucocorticoid to induce remission
    • Telitacicept (80 mg) administered subcutaneously once weekly for 12 months
    • Tapering of glucocorticoid based on 2022 European Alliance of Associations for Rheumatology (EULAR) recommendation
  • Placebo comparator arm
    • Rituximab plus glucocorticoid to induce remission
    • Placebo of telitacicept (80 mg) administered subcutaneously once weekly for 12 months
    • Tapering of glucocorticoid based on 2022 EULAR recommendation

Read more about AAV treatment

The primary outcome measure of the study is the time from baseline to initial relapse during 24 months of follow-up in the 2 treatment arms (ie, reappearance of disease with a Birmingham Vasculitis Activity Score [BVAS] of >0). Secondary outcome measures include the following:

  • Time from baseline to remission in both groups (ie, disappearance of disease with a BVAS of 0) during 24 months of follow-up
  • Time from remission to initial relapse
  • Percentage of participants with sustained remission at 12 and 24 months
  • Percentage of participants with relapse at 12 and 24 months
  • Rate of adverse events and their severity over 24 months
  • Percentage of participants progressing to end-stage renal disease at the end of the study
  • Time of ANCA from positive to negative
  • Rate of complications from AAV during the 24-month study period

Study inclusion criteria are as follows:

  • Age between 18 and 65 years; either gender;
  • Individuals with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) must meet the 2022 American College of Rheumatology (ACR)/EULAR criteria for GPA/MPA;
  • Severe active AAV, based on 2021 ACR/vasculitis foundation definition; and
  • Proteinase 3 (PR3)-ANCA–positive at diagnosis or during disease course.

AAV comprises a group of rare autoimmune conditions characterized by inflammation and the destruction of predominantly small blood vessels.

Reference

Efficacy and safety for rituximab combined with telitacicept in the treatment of ANCA-associated vasculitis (TTCAAVREM). ClinicalTrials.gov. July 27, 2023. Accessed July 31, 2023.

glucocorticoids immunologists Nephrologists rheumatologists rituximab telitacicept TTCAAVREM study