CLINICAL TRIALs SHOWED POSITIVE RESULTS IN PLASMA ADA ACTIVITY, dAXP CONCENTRATIONS, AND TOTAL LYMPHOCYTE COUNTS
U.S. Study description: Phase III, open-label, multicenter, single-arm, one-way crossover study of Revcovi, conducted in the United States. The purpose of this clinical study was to evaluate the safety, efficacy, and pharmacokinetics (PK) of Revcovi in six U.S. patients with ADA-SCID who were receiving therapy with Adagen. The study consisted of three phases: an Adagen Lead-in phase (minimum of 3 weeks), followed by Revcovi Treatment (weeks 1 through 21) and Maintenance phases. The starting weekly dose of Revcovi was calculated based on the last Adagen dose received in the study. Weekly Revcovi doses ranged from 0.188 mg/kg to 0.292 mg/kg. The study showed positive results in reduction of dAXP concentrations, stable, target plasma ADA activity, and total lymphocyte count maintenance or improvement.
A Japanese multicenter trial (four patients) showed similar improvements in ADA activity levels, dAXP concentration, and total lymphocyte counts.1, 2
Revcovi (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
Important safety information
Warnings and precautions:
- Injection site bleeding in patients with thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia; should not be used if thrombocytopenia is severe.
- Delay in improvement of immune function: Protect immune deficient patients from infections until improvement in immune function.
The most commonly reported adverse reactions were cough and vomiting.
In addition, the following post-marketing reports for the same class of enzyme replacement therapy used in the treatment of ADA-SCID, may also be seen with Revcovi treatment:
- Hematologic events: hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia
- Dermatological events: injection site erythema, urticaria
Important monitoring information:
Treatment with Revcovi should be monitored by measuring trough plasma ADA activity and trough dAXP levels for maintenance of therapeutic targets. If a persistent decline in plasma ADA activity occurs, immune function and clinical status should be monitored closely, and precautions should be taken to minimize the risk of infection.
Please refer to Revcovi’s Full Prescribing Information.