Jyseleca
Immunology· 2003 cited findings· 2 source documents
Company: Alfasigma S p A
What the regulatory reviews say
Jyseleca is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). It may be used as monotherapy or in combination with methotrexate (MTX).
Efficacy findings include an ACR20 response rate of 81.0% and 80.2% for Jyseleca, compared to 71.4% for adalimumab. Remission (DAS28(CRP) < 2.6) at Week 24 was observed in 54.1% and 42.5% of patients treated with Jyseleca. At Week 12, LDA (DAS28 [CRP] ≤ 3.2) was achieved by 40.8% and 37.3% of patients.
Safety data indicates 4120 subjects were exposed to filgotinib, with a total of 7218.36 patient-years of exposure. The mortality rate for filgotinib 200 mg was 0.5 E/100 PY, and for filgotinib 100 mg, it was 0.3 E/100 PYs. The Marketing Authorisation Application was submitted on 24 July 2019, with a CHMP positive opinion issued on 23 July 2020.
Key figures — cited to the source page
| ACR20 response rate (%) | 81.0 | Alfasigma S p A — Jyseleca EMA EPAR public assessment report, p.74 |
| ACR20 response rate (%) | 71.4 | Alfasigma S p A — Jyseleca EMA EPAR public assessment report, p.74 |
| Remission (DAS28(CRP) < 2.6) at Week 24 (%) | 54.1 | Alfasigma S p A — Jyseleca EMA EPAR public assessment report, p.74 |
| LDA (DAS28 [CRP] ≤ 3.2) at Week 12 (%) | 40.8 | Alfasigma S p A — Jyseleca EMA EPAR public assessment report, p.71 |
| Mortality rate for filgotinib 200 mg | 0.5 | Alfasigma S p A — Jyseleca EMA EPAR public assessment report, p.142 |
| Mortality rate for filgotinib 100 mg | 0.3 | Alfasigma S p A — Jyseleca EMA EPAR public assessment report, p.142 |
| Marketing authorization application submission date | 24 July 2019 | Alfasigma S p A — Jyseleca EMA EPAR public assessment report, p.8 |
| CHMP positive opinion for marketing authorisation | 23 July 2020 | Alfasigma S p A — Jyseleca EMA EPAR public assessment report, p.11 |
Source documents
Explore the full evidence
All 2003 cited findings for Jyseleca — searchable, comparable and answerable in plain language — are in the Immunology research library →
Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.