Additional safety results from an interim analysis1,2
At the data cutoff (December 2021)
- Thirty-seven of 38 patients received Joenja for at least 25 weeks; 66% were exposed for 96 weeks or longer
- Median duration of Joenja treatment was approximately 2 years
- Four patients had more than 5 years of Joenja exposure
Distribution and grades* of AEs
- Thirty-two of 37 patients had ≥1 AE
(333 AEs reported)
- 78.4% were grade 1, 48.6% were grade 2,
and 27% were grade 3
- No grade 4 AEs reported
- One grade 5 (patient died on day 879);
investigator determined that it was not
related to study drug
- No serious AEs were related to Joenja
AEs associated with Joenja
- The AEs reported as related to study drug were weight increase (3 patients), arthralgia (1 patient), hyperglycemia (1 patient), and decreased neutrophil count (1 patient)
*CTCAE were used to determine AE grade. If CTCAE grading did not exist for an AE, the following definitions were used: 1, mild; 2, moderate; 3, severe; 4, life-threatening; 5, death.
AE, adverse event; CTCAE, common terminology criteria for adverse events; OLE, open-label extension.
ADDITIONAL FINDINGS FROM THE OLE STUDY
Annual infection rates2
Infection rates reported per each additional year of treatment with Joenja
in particular bacterial enterocolitis. Patients were not provided an infection diary to document infections occurring between visits.
Physician-reported IRTreductions and discontinuations2
Twenty-seven Joenja patients were receiving IRT at the start of the OLE study
- Four patients had been IRT free for 1 to 2.5 years
- The median time to IRT reduction was 12.1 months and the median time to IRT discontinuation was 11.9 months
Not actual patients.
immunodeficiency. Hyperactivity along the Pl3Kδ signaling pathway disrupts immune cell balance, causing immune deficiency and immune