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JAK inhibitors

Immunologyยท 6 reviewed drugsยท 17762 cited findings behind them

What the regulatory reviews cover

This library includes several Janus kinase (JAK) inhibitors that have undergone regulatory review for various indications. Rinvoq was reviewed for the treatment of adults and pediatric patients with refractory, moderate-to-severe atopic dermatitis and moderate to severe active rheumatoid arthritis. Olumiant was reviewed for moderate to severe active rheumatoid arthritis. Sotyktu was reviewed for moderate to severe plaque psoriasis and active psoriatic arthritis. Cibinqo was reviewed for moderate-to-severe atopic dermatitis in adults and adolescents. Xeljanz was reviewed for moderately to severely active ulcerative colitis and rheumatoid arthritis. Jyseleca was reviewed for moderate to severe active rheumatoid arthritis.

Regulatory documents report various efficacy and safety outcomes. For example, Rinvoq demonstrated statistically superior efficacy vs placebo for co-primary endpoints (IGA 0-1 and EASI-75). Olumiant showed an ACR20 response rate difference vs placebo of 29.4. Cibinqo reported an IGA 0 or 1 responder rate (abrocitinib) of 42.8 compared to 7.9 for placebo. Jyseleca achieved a Remission (DAS28(CRP) < 2.6) at Week 24 (%) of 54.1. It is important to note that these drugs were studied in different trials, and therefore, the reported figures are not directly comparable in a head-to-head manner.

The drugs โ€” one cited result each

Rinvoq

AbbVie Inc.

Efficacy vs placebo for co-primary endpoints (IGA 0-1 and EASI-75): statistically superior

ABBVIE โ€” Rinvoq FDA Review (NDA/BLA 211675, 2024), p.84

Olumiant

Eli Lilly and Company

ACR20 response rate difference vs placebo: 29.4

Eli Lilly and Company โ€” Olumiant EMA EPAR public assessment, p.65

Sotyktu

Bristol-Myers Squibb Company

Statistical significance for co-primary endpoints (sPGA 0/1 and PASI 75): achieved

Bristol-Myers Squibb Company โ€” Sotyktu EMA EPAR public asses, p.112

Cibinqo

Pfizer Inc.

IGA 0 or 1 responder rate (abrocitinib): 42.8

Pfizer Inc. โ€” Cibinqo FDA Review (NDA213871, ORIG 1, 2022), p.24

Xeljanz

Pfizer Inc.

Proportion of patients in remission at week 8: 18%

PF PRISM CV โ€” Xeljanz FDA Review (NDA/BLA 203214, 2022), p.80

Jyseleca

Alfasigma S p A

Remission (DAS28(CRP) < 2.6) at Week 24 (%): 54.1

Alfasigma S p A โ€” Jyseleca EMA EPAR public assessment report, p.74

Different drugs were studied in different trials โ€” these figures are not head-to-head comparisons.

Explore the full evidence

Every finding behind these drugs โ€” searchable, comparable and answerable in plain language โ€” is in the Immunology research library โ†’

Lists reflect the regulatory review documents in this library, not all therapies that exist. Educational reference only โ€” not medical or investment advice.

JAK inhibitors โ€” 6 Drugs Compared from FDA & EMA Reviews | BioPharmaPT Immunology