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Effekt og sikkerhetEffekt RARask respons (ACR20)Head-to-Head data (ACR50)Effekt PsAACR20 effektdataPASI75 effektdataEntesitt og Dactylitt effektdataEffekt ASASAS20/40 effektdataASDAS(CRP) effektdataEffekt UC8-ukers effektdataStart av effekt52-ukers effektdataOCTAVE StudiedesignEffekt JIASykdoms oppblussACR30/50/70 effektdataSikkerhetSikkerhetsprofilUtvalgte bivirkningerUnormale laboratorieverdierOm XELJANZOm XELJANZJAKi erfaringerXELJANZ virkningsmekanismeHvem kan bruke XELJANZDosering og administrasjonDosering og administrasjonDosering RA/PsA/ASDosering UCDosering JIALaboratorieovervåkningOpplæringsmateriellOpplæringsmateriellMateriellVideo
OCTAVE StudiedesignEffekt og sikkerhet fastslått i 3 store, multisenter, randomiserte, dobbeltblinde, placebokontrollerte fase 3-studier og en åpen studie av pasienter med moderat til alvorlig UC1OCTAVE Clinical Program Design

Figure adapted from Sandborn WJ, Su C, Sands BE, et al; for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736.

To avoid potential bias, evaluation of endoscopies was conducted by readers who were blinded to treatment (XELJANZ or placebo) and had no contact with patients, investigators, or other individuals involved in the study.1Responders/response were defined as subjects with a decrease from baseline in Mayo score of 3 points and 30%, with an accompanying decrease in the subscore for rectal bleeding of >1 point or absolute subscore for rectal bleeding of 0 or 1.1​​​​​​​Remitters/remission were defined as subjects with a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0.1

The recommended dose for maintenance treatment is XELJANZ® 5 mg BID. When induction treatment is complete, the dosage should be decreased from 10 mg BID to 5 mg BID.2

  • The primary efficacy endpoint in the OCTAVE Induction 1 and 2 trials was remission at week 8, and in the OCTAVE Sustain trial, it was remission at week 521,c
  • The XELJANZ induction and maintenance trials incorporated a more rigorous definition of remission that required the absence of any rectal bleeding (Mayo subscore of 0), unlike previous clinical trials for treatments of UC1
  • ​​​​​​​Patients who completed one of the OCTAVE Induction studies but did not achieve clinical response or patients who completed or withdrew early due to treatment failure on XELJANZ or placebo in the maintenance study were eligible for the open-label extension study. OCTAVE Open is a safety and tolerability study1​​​​​​​
  • ​​​​​​​Patients were assessed using the Mayo scale, a tool for evaluating disease activity in UC patients that is composed of 4 subscores (stool frequency, rectal bleeding, endoscopic findings, and Physician’s Global Assessment), each with a range of 0 to 3 (higher scores indicate more severe disease)1
Pasientkarakteristika ved baseline for deltakere i XELJANZ UC-studien1

Figure adapted from Sandborn WJ, Su C, Sands BE, et al; for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736.

Steroids were required to be stable during induction and tapered off during maintenance.1Finn ut mer Vil du vite mer om sikkerhetsprofilen til XELJANZ? Se Sikkerhetsprofil

BID=twice daily; TNF=tumor necrosis factor; UC=ulcerative colitis.

Referanser:Sandborn WJ, Su C, Sands BE, et al; for the OCTAVE Induction 1, OCTAVE Induction 2, and OCTAVE Sustain Investigators. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376(18):1723-1736.XELJANZ SPC
Preparatomtale
PP-XEL-NOR-0335 Mai 2023
Effekt UC
SIKKERHET

Les mer om XELJANZ-sikkerhetsprofilen

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DOSERING

Lær om dosering med XELJANZ innen UC

Dosering UC
ERFARINGER

Lær omerfaringene ved bruk av XELJANZ innen RA, PsA, AS, UC og JIA

XELJANZ erfaringer

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