Cibinqo (abrocitinib)

Cibinqo er et oralt legemiddel for pasienter med moderat til alvorlig atopisk dermatitt (AD) hos voksne som er aktuelle for systemisk behandling.

Cibinqo er et småmolekylært (ikke-biologisk) legemiddel i tablettform.

Om Cibinqo (bli kjent med)

Hvorfor bruke Cibinqo

Kliniske studier

Sikkerhetsinformasjon

Dosering og administrasjon

Atopisk dermatitt

Cibinqo har vist:

  • Rask kløelindrende effekt med Cibinqo 200 mg; significant bedre enn dupilumab ved uke 2 hos pasienter som oppnådde PP-NRS4 (henholdsvis 49,1 % vs 26,4 %),2 med høyere kløerespons sett så tidlig som dag 4 etter første dose‡1
  • Signifikant hudforbedring vs placebo ved uke 12,*2–4 med vedvarende effekt gjennom uke 48†1
  • Fleksibel dosering ved å starte på 200 mg eller 100 mg§. Under behandlingen kan dosen økes eller reduseres for å nå behandlingsmål som er satt for den enkelte pasient
  • Sikkerhetsdata hos totalt 3128 pasienter i kliniske studier av atopisk dermatitt, noe som representerer 2089 pasientår med eksponering.

*In JADE MONO-1 and MONO-2 (monotherapy), a significantly higher proportion of patients achieved EASI-75 at Week 12 with Cibinqo 200 mg (62.7%; 61.0%) and Cibinqo 100 mg  (39.7%; 44.5%), compared with placebo (11.8%; 10.4% [P<0.0001 for both doses vs placebo]). In COMPARE, when used in combination with medicated topical therapy, EASI-75 response at Week 12 was observed in 70.3% of patients in the Cibinqo 200 mg group, 58.7% in Cibinqo 100 mg, and 27.1% in placebo (P<0.001 for both doses vs placebo).

†Among patients who achieved EASI-75 after 12 weeks of treatment and entered JADE EXTEND, 71% and 69% of patients in the Cibinqo 200 mg and 100 mg groups maintained EASI-75 at Week 48, respectively.

‡In JADE COMPARE, Cibinqo 200 mg was compared with dupilumab in the key secondary head-to-head endpoint, PP-NRS4 at Week 2. This endpoint was further analysed as a prespecified multiplicity-controlled analysis and showed superiority to dupilumab down to Day 4. PP-NRS4 response is defined as a 4 or greater reduction in itch score from baseline on a scale of 0 to 10.

§For most patients, particularly those with severe disease, the recommended starting dose is 200 mg. A dose of 100 mg once daily is the recommended starting dose for patients aged ≥65 years, adolescents (12–17 years old), and for those who have risk factors for developing an adverse reaction to Cibinqo or those who are less likely to tolerate the adverse reactions. The maximum dose of Cibinqo is 200 mg once daily.

AD=atopic dermatitis; EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; JAK=Janus kinase; PP-NRS=Peak Pruritus Numerical Rating Scale.
 

Referanser:

1. Cibinqo SPC, 2. Bieber T, et al. N Eng J Med 2021;384:1101–1112. 3. Simpson E, et al. Lancet 2020;395:P255–266. 4. Silverberg J, et al. JAMA Dermatol 2021;156(8):863–873.

PP-CIB-NOR-0001