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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
52-ukers effektdata ved UC>3 ganger så mange pasienter behandlet med XELJANZ® vedlikeholdsbehandling oppnådde remisjon uten rektal blødning sammenlignet med placebo1XELJANZ 5 mg BID vedlikeholdsbehandling oppnådde signifikant høyere remisjonsratea ved uke 52 sammenlignet med
placebo1(Central Readb Data From OCTAVE Sustain Maintenance Study)1

Adapted from Sandborn WJ, et al. N Engl J Med. 2017;376(18):1723-1736.

Remission (primary endpoint) was defined as a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0.1To limit 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.1Includes all patients, TNFi naïve and TNFi exposures.1XELJANZ betydelig forbedret endoskopisk slimhinnetilhelning vs placebo1XELJANZ 5 mg BID forbedret endoskopisk slimhinnetilhelning vs placebo ved uke 521(Central Readb Data From OCTAVE Sustain Maintenance Study)1

Example

Example

Example

Adapted from Sandborn WJ, et al. N Engl J Med. 2017;376(18):1723-1736.

Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopic findings subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern).1To limit 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.1,2Includes all patients, TNFi naïve and TNFi exposures.1XELJANZ økte signifikant vedvarende steroidfrie remisjonsrater vs placebo1En større andel av pasientene som tok XELJANZ 5 mg BID, oppnådde vedvarende steroidfri remisjon sammenlignet med placebo både ved uke 24 og 521(Data From OCTAVE Sustain Maintenance Study)1

Adapted from Sandborn WJ, et al. N Engl J Med. 2017;376(18):1723-1736.

Sustained steroid-free remission was defined as being in remission and on no corticosteroids for at least 4 weeks prior to the visit at both week 24 and week 52 among those in remission at maintenance baseline.1Includes all patients, TNFi naïve and TNFi exposures.1XELJANZ viste overlegne resultater sammenlignet med placebo, selv hos pasienter med tidligere TNFi-svikt1XELJANZ forbedret Mayo score signifikant hos flere pasienter som mislyktes med tidligere TNFi-behandling sammenlignet med placebo ved uke 521(Data From OCTAVE Sustain Maintenance Study: TNFi-failure Patients Only)1

Adapted from Sandborn WJ, et al. N Engl J Med. 2017;376(18):1723-1736.

Maintenance treatment with XELJANZ 10 mg BID should be limited to patients who are not at increased risk for VTE, who experience a decrease in response on XELJANZ 5 mg BID, or who fail to respond to alternative treatment options (eg, TNFi therapy). XELJANZ 10 mg twice daily for maintenance treatment should be used for the shortest duration possible. The lowest effective dose needed to maintain response should be used.2,a,d

Remission was defined as a Mayo score ≤2 with no individual subscore >1 and a rectal bleeding subscore of 0.1Improvement of endoscopic appearance of the mucosa was defined as Mayo endoscopic findings subscore of 0 (normal or inactive disease) or 1 (erythema, decreased vascular pattern). To limit 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.1Sustained steroid-free remission was defined as being in remission and on no corticosteroids for at least 4 weeks prior to the visit at both weeks 24 and 52 among those in remission at maintenance baseline.1Please refer to your approved local/regional label for guidance on appropriate language.Finn ut mer Vil du høre mer om OCTAVE studieprogram? Les mer

BID=twice daily; TNFi=tumor necrosis factor inhibitor; VTE=venous thromboembolism.

References: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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