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AboutAboutHow XELJANZ worksXELJANZ in ActionCytokinesSignalling PathwaysDosingDosingDosing in RADosing in UCDosing in PsADosing in pJIA and jPsADosing in ASSpecial Warnings & PrecautionsEfficacy & SafetyEfficacy & SafetySafety & TolerabilityOral SurveillanceAdverse EventsClinical Efficacy RAORAL Strategy Study DesignORAL Strategy Efficacy ResultsORAL Strategy Safety OutcomesClinical Efficacy UCOCTAVE Study DesignOCTAVE Sub GroupsOCTAVE InductionOCTAVE SustainPost-hoc AnalysesClinical Efficacy PsAOPAL Broaden & BeyondClinical Efficacy pJIA and jPsAJIA-1 Study DesignJIA-1 Efficacy ResultsJIA-1 Safety OutcomesClinical Efficacy ASASAS20/40 DataASDAS(CRP) DataReal World EvidenceReal World EvidenceReal World Evidence
Why Real-World Data?Key Characteristics of RCTs & RWEKey Strengths & Limitations
STAR-RAMalignancy Study DesignMalignancy Risk OutcomesCV Risk Study DesignCV Risk OutcomesSCQM-RAStudy DesignStudy OutcomesCorEvitas RASafety Study DesignEfficacy Study DesignOutcomesUC RWETOUR Registry (US)Honap Study (UK)
Supporting ResourcesSupporting ResourcesMaterialsVideosGRAPPA GuidelinesExpert OpinionsProfessor RamananDr James GallowayProfessor KielyDr Cole

XELJANZ® (tofacitinib citrate) Prescribing Information and Maxtrex (methotrexate) Prescribing Information. Adverse event reporting can be found at the bottom of the page.
 
 Tofacitinib should only be used if no suitable treatment alternatives are available in patients:

  • 65 years of age and older;
  • patients with history of atherosclerotic cardiovascular disease or other cardiovascular risk factors (such as current or past long-time smokers);
  • patients with malignancy risk factors (e.g. current malignancy or history of malignancy)

 These risks are considered class effects and relevant across all approved indications of JAKi in inflammatory and dermatologic diseases.

XELJANZ (tofacitinib citrate):
First oral JAK inhibitor licensed for 5 indications

 
XELJANZ is a Janus kinase (JAK) inhibitor that helps regulate an overactive immune system. It helps disrupt JAK pathways from inside the cells, which are believed to play a role in inflammation.

It is an oral, small molecule drug used to treat adults with moderate to severe active rheumatoid arthritis (RA), active psoriatic arthritis, moderate to severe ulcerative colitis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis for children aged 2 and older.


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XELJANZ in Gastroenterology or XELJANZ in Rheumatology

XELJANZ in action

Find out more about XELJANZ (tofacitinib citrate) mode of action.

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Rheumatoid Arthritis​​​​​​​​​​​​​​​​​​​​

Find the information you need to support your RA patient.

RA Dosing Loading
Ulcerative Colitis​​​​​​​​​​​​​

Find the information you need to support your UC patient.

UC Dosing

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Psoriatic Arthritis

Find the information you need to support your PsA patient.

PsA Dosing Loading
Polyarticular Juvenile Idiopathic Arthritis (pJIA) and juvenile Psoriatic Arthritis (jPsA) 

Find the information you need to support your pJIA or jPsA patient.

pJIA and jPsA Dosing Loading
Ankylosing Spondylitis

Find the information you need to support your AS patient.

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Gastroenterology

Clinical efficacy in UC
OCTAVE InductionOCTAVE Induction 1 and 2 were two identical studies of patients with moderately to severely active disease to assess the efficacy and safety of XELJANZ in inducing remission2 Read studyLoading OCTAVE Sustain

OCTAVE Sustain was a study of patients who had achieved clinical response in the two OCTAVE Induction studies to assess the efficacy and safety of XELJANZ in maintaining remission2

Read studyLoading
Expert videos and podcasts

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Example

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Prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies

Professor Charlie Lees discusses the prediction of early clinical response in patients receiving tofacitinib in the OCTAVE Induction 1 and 2 studies.

Example

Example

Settling Behaviours Part 1

A three part series looking at addressing behaviours for patients with inflammatory bowel disease.

Anna Karoliina Ylänne discusses why might patients with inflammatory bowel disease be settling for suboptimal therapy. 

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Rheumatology

Clinical efficacy
ORAL Strategy Study Design12-month Phase IIIb/IV non-inferiority study in 1,146 patients with moderate to severe active RA with an inadequate response to MTX3
 
Read studyLoading
ORAL Strategy Efficacy Results

Completed head-to-head non-inferiority study comparing XELJANZ and adalimumab in patients with inadequate response to MTX
 

Read studyLoading
Expert videos and podcasts

Example

Example

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ORAL Surveillance study in Rheumatoid Arthritis | Dr James Galloway

In this video, Dr James Galloway, respected rheumatologist and researcher, talks about the ORAL Surveillance study and its implications for the use of tofacitinib in the treatment of RA.

Example

Example

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RA Insights - Fatigue in Inflammatory Arthritis

Dr Sarah Mackie and Dr Ai Lyn Tan present recent insights into fatigue in RA and PsA. They discuss the discordance between physicians and patients when it comes to assessing fatigue, the association of fatigue with other co-morbidities and clinical outcomes and novel approaches to managing fatigue. 

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Visit our therapy area siteInflammation therapy area

Find a range of articles and training support on our inflammation therapy area on PfizerPro.

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References:
1. Data on file, Pfizer UK (REF-XEL25316)
2. Sandborn WJ et al. N Engl J Med 2017; 376(18): 1723–1736.
3. Fleischmann R et al. Lancet 2017; 390:457–468

XELJANZ Risk Minimisation Programme (RMP) materials, including a Patient Alert Card, Prescriber Checklists and a Prescriber Brochure are available from https://www.medicines.org.uk/emc/. Patients treated with XELJANZ should be given the Patient Alert Card.
PP-XEL-GBR-4378. April 2023

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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