Consistent safety profile across clinical studies
Adverse reactions were more frequently reported during Up-Dosing and decreased during Maintenance dosing.1
Study 1 (PALISADE) was a randomized, double-blind, placebo-controlled efficacy and safety study where participants were Up-Dosed for 20 to 40 weeks followed by Maintenance dosing for 24 to 28 weeks.
Study 2 (RAMSES) was a randomized, double-blind, placebo-controlled safety study where participants were Up-Dosed for 20 to 40 weeks up to 300 mg daily dose with no extended Maintenance dosing.
Most frequently reported adverse reactions in participants aged 4 through 17 years1*
Symptoms during in-office PALFORZIA dosing had a median time to onset of 4 minutes for 71% of participants. Median time to resolution was 37 minutes.1
Organized by system organ class/preferred term.†
- *Treatment-emergent adverse reactions reported in ≥5% of participants treated with PALFORZIA and ≥5% percentage points greater than reported in participants treated with placebo in any dosing phase (aged 4 through 17 years).
- †Adverse events were coded to system organ class and preferred term using the MedDRA, version 19.1.
- In Study 2, no adverse events ≥5% were reported in participants following treatment with 300 mg PALFORZIA (N=265).
- ‡Includes preferred terms of abdominal pain, abdominal pain upper, and abdominal discomfort.
- §Includes preferred terms of oral pruritus, tongue pruritus, and lip pruritus.
- ¶The anaphylactic reaction preferred term includes systemic allergic reactions of any severity, or which severe anaphylaxis was reported in four PALFORZIA-treated participants (0.6%) during Up-Dosing and one PALFORZIA-treated participant (0.3%) during Maintenance.
MedDRA = Medical Dictionary for Regulatory Activities.