Oral tyrosine kinase 2 inhibitor PF-06826647 demonstrates efficacy and an acceptable safety profile in participants with moderate-to-severe plaque psoriasis in a phase 2b, randomized, double-blind, placebo-controlled study.
J Am Acad Dermatol
; 87(2): 333-342, 2022 08.
Article
en En
| MEDLINE
| ID: mdl-35398218
ABSTRACT
BACKGROUND:
Psoriasis treatments lack durable efficacy and have inconvenient administration, highlighting the need for new therapies.OBJECTIVE:
To evaluate the efficacy and safety of tyrosine kinase 2 inhibitor, PF-06826647, in moderate-to-severe plaque psoriasis.METHODS:
This phase 2b, double-blind study randomized participants to oral, once-daily PF-06826647 (11222) 50100200400 mgplacebo (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.RESULTS:
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 = .0004) and 400-mg (46.5 [30.6, 60.6], P < .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 < .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:
Limitations included the large proportion of White males and non-placebo-controlled extension.CONCLUSION:
PF-06826647 200 and 400 mg once daily showed significant efficacy versus placebo at week 16 and was well tolerated over 40 weeks.Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Psoriasis
/
Inhibidores de Proteínas Quinasas
/
TYK2 Quinasa
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
Límite:
Humans
Idioma:
En
Revista:
J Am Acad Dermatol
Año:
2022
Tipo del documento:
Article