Tildrakizumab for the prophylaxis of graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
Abstract
Abstract: We conducted a phase 1/2 study in which patients undergoing allogeneic hematopoietic stem cell transplantation received tildrakizumab in addition to standard immune suppression with tacrolimus and methotrexate for graft-versus-host disease (GVHD) prophylaxis. A total of 50 patients were enrolled between March 2020 and June 2023 with a median age of 56 years (range, 19-64). All patients received myeloablative busulfan-based conditioning and were transplanted with HLA-matched related or unrelated peripheral blood stem cell grafts. Patients were treated with tildrakizumab on an extended subcutaneous administration schedule for 5 doses, which was well tolerated. The cumulative incidences of grades 2 to 4 and 3 to 4 acute GVHD were 14% (95% confidence interval [CI], 7-28) and 4% (95% CI, 1-16) at day 100, respectively. The incidence of chronic GVHD requiring systemic immune suppression was 52.7% (95% CI, 40.4-68.9) at 12 months. The 1-year probabilities of overall, disease-free, and GVHD-free relapse-free survival were 80% (95% CI, 70-92), 78% (95% CI, 67-90), and 19.3% (90% CI, 11.8-31.4), respectively. Pharmacokinetic analysis revealed the half-life of tildrakizumab at ∼28 days without formation of detectable anti-tildrakizumab-neutralizing antibodies. Comparative examination of fecal microbial composition in tildrakizumab and a similarly transplanted cohort treated with tocilizumab prophylaxis demonstrated that both cytokine blockade strategies had a low frequency of…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 50 participants or records.
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