- Il presente studio di fase 2b, in doppio cieco, randomizzato, ha valutato l’efficacia e la sicurezza dell’inibitore orale della tirosin-chinasi PF-06826647 nel trattamento della psoriasi in placche moderata-severa.
- PF-06826647 200 e 400 mg in monosomministrazione giornaliera ha mostrato un’efficacia significativamente maggiore rispetto al placebo a 16 settimane ed è stato ben tollerato nel periodo di 40 settimane.
Psoriasis treatments lack durable efficacy and have inconvenient administration, highlighting the need for new therapies.
To evaluate the efficacy and safety of tyrosine kinase 2 inhibitor, PF-06826647, in moderate-to-severe plaque psoriasis.
This phase 2b, double-blind study randomized participants to oral, once-daily PF-06826647 (1:1:2:2:2) 50:100:200:400 mg:placebo (16 weeks), then 200 or 400 mg (24 weeks) (NCT03895372). The primary end point was a proportion of participants achieving psoriasis area severity index (PASI) 90 at week 16. Secondary end points (PASI50/75/90/100; Physician’s Global Assessment) and safety were assessed to week 40.
Overall, 178 participants were treated. A significantly greater proportion of participants (risk difference % [90% CI]) achieved PASI90 in the 200-mg (33.0 [18.0, 47.1], p = 0.0004) and 400-mg (46.5 [30.6, 60.6], p <0.0001; week 16) groups versus placebo. Significant increases from placebo were observed for all secondary end points (200 and 400 mg; weeks 6-16; p <0.05); increases were evident to week 40 (categorical data). PF-06826647 was well tolerated and most treatment-emergent adverse events were mild/moderate. Eighteen participants discontinued due to treatment-emergent adverse events (14 arising from laboratory abnormalities).
Limitations included the large proportion of White males and non-placebo-controlled extension.
PF-06826647 200 and 400 mg once daily showed significant efficacy versus placebo at week 16 and was well tolerated over 40 weeks.