Title: Efficacy and safety of adalimumab every other week versus methotrexate once weekly in children and adolescents with severe chronic plaque psoriasis: a randomised, double-blind, phase 3 trial
Papp, K. et al.
What You Need to Know:
In children and adolescents with severe plaque psoriasis, adalimumab 0.8 mg/kg demonstrated superior efficacy to methotrexate by significantly improving Psoriasis Area and Severity Index (PASI) scores.
- Multicenter, randomized, double-blind, phase 3 trial evaluated the efficacy and safety of treatment with adalimumab for patients ages 4-18 years with severe plaque psoriasis not responsive to topical therapy
- 114 patients randomized (1:1:1) to subcutaneous administration of adalimumab 0.8 mg/kg or 0.4mg/kg given every other week or oral methotrexate 0.1-0.4 mg/kg given once weekly for 16 weeks
- Primary endpoints: proportion of patients attaining 75% improvement in PASI score (PASI75) from baseline, clear or minimal score on physician global assessment (PGA) scale at week 16
- Efficacy data: intention-to-treat analysis
- Safety data: included all patients that received 1 dose of study medication
- 58% of adalimumab 0.8 mg/kg patients (22/38) achieved PASI75 vs 32% of methotrexate patients (12/37) at week 16 (P=0.027)
- 61% of adalimumab 0.8 mg/kg patients (23/38) achieved clear or minimal PGA vs 41% of methotrexate patients (15/37) (P=0.083)
- Adalimumab 0.4 mg/kg group: 44% (17/39) achieved PASI75 and 41% (16/38) achieved clear or minimal PGA
- Most common adverse event: infections (reported by 45% of adalimumab 0.8 mg/kg group, 56% of adalimumab 0.4 mg/kg group, and 57% of methotrexate group)
- Serious adverse events reported deemed unrelated to study medications