RINVOQ®(upadacitinib) Revmatoid artritt (RA)
RINVOQ er indisert til behandling av moderat til alvorlig aktiv revmatoid artritt hos voksne pasienter som har respondert utilstrekkelig på eller er intolerante overfor ett eller flere sykdomsmodifiserende antirevmatiske legemidler (DMARDs). RINVOQ kan brukes som monoterapi eller i kombinasjon med metotreksat1.
▼Dette legemidlet er underlagt særlig overvåking for å oppdage ny sikkerhetsinformasjon så raskt som mulig. Helsepersonell oppfordres til å melde enhver mistenkt bivirkning.
Dette gjøres via meldeskjema som finnes på nettsiden til Statens Legemiddelverk: www.legemiddelverket.no/meldeskjema.
Referanse: 1. RINVOQ SPC avsnitt 4.1, sist oppdatert 16.09.2021.
The study evaluated 2 doses of upadacitinib, 15 mg and 30 mg QD. The results presented here are for RINVOQ (upadacitinib) 15 mg once daily, which is the approved dose for Rheumatoid Arthritis.
Primary
RINVOQ 15 mg + csDMARD(s) vs placebo + csDMARD(s) at Week 12 for DAS28 (CRP) <3.2 or ACR20
Safety
Adverse events, serious adverse events, adverse events of special interest (e.g., serious infections, opportunistic infections, MACEs, VTEs, malignancies)
ACR: American College of Rheumatology; ACR20: improvement of at least 20% in the American College of Rheumatology core criteria; bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DAS28 (CRP): disease activity score with 28 joint count (C-reactive protein); MACE: major adverse cardiovascular event; MTX: methotrexate; QD: once daily; VTE: venous thromboembolic event.
SELECT-BEYOND: Previous bDMARD received1
Adapted from Tabel 1, Genovese MC et al. Lancet 2018;391(10139):2513-2524
RINVOQ 15 mg: Efficacy across endpoints
SELECT-BEYOND: Low disease activity and remission at Week 12 in patients with an inadequate response to bDMARDs (NRI)1,2
*P≤0.001 vs placebo + csDMARD(s)
bDMARD: biological disease-modifying antirheumatic drug; csDMARD: conventional synthetic disease-modifying antirheumatic drug; DAS28 (CRP): disease activity score with 28-joint count (C-reactive protein); NRI: nonresponder imputation.
SELECT-BEYOND: Adverse events through 12 weeks of treatment1,2
No patients reported tuberculosis, nonmelanoma skin cancer, or lymphoma.
*These were oral candidiasis.
†Most cases were mild and all but 1 was a single dermatome; 2 cases were serious.
‡One malignant melanoma in RINVOQ 15-mg group, Weeks 0–12.
§One ischemic stroke in Weeks 0–12 in RINVOQ 15-mg group.
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Referanser
- Genovese MC, Fleischmann R, Combe B, et al. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease- modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018;391(10139):2513-2524. doi:10.1016/S0140- 6736(18)31116-4
- RINVOQ SPC avsnitt 5.1, sist oppdatert 21.05.2021.
NO-RNQ-200017v2.0juni/2021