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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)Tursi Study (Italy)
Supporting ResourcesSupporting ResourcesMaterialsGRAPPA GuidelinesVideosExpert Opinions

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.

Tursi et al:  ​Retrospective, Obserational, Multicenter Study of Effectiveness and Safety of Xeljanz in UC Patients in Italy Real World Evidence for Ulcerative Colitis Study Design Loading
Study Results 
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Tofacitinib is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Study Design1 Study Objective1

Tursi, et al carried out an observational, retrospective, multicenter study which was conducted to investigate the effectiveness and safety of XELJANZ in UC patients in Italy1.

This study was not sponsored by Pfizer.

Study Cohort1

166 patients who completed at least XELJANZ induction treatment between September 1, 2021 and October 1, 2022 were included.​


Inclusion criteria: ​

  • Adult patients with an established UC diagnosis based on standard endoscopic, radiology, and histological criteria ​

  • Patients presented with moderate-to-severe active UC

Baselines Characteristics1
  XELJANZ
(N=166)
Male sex, n (%) 98 (59.0)
Median age at diagnosis, years (IQR)  42 (39–45)
Median disease duration prior to XELJANZ, years (IQR)  8 (7–10)
Current smokers, n (%) 24 (14.5)
Presence of comorbidities, n (%) 61 (36.7)
Presence of rheumatoid diseases, n (%)  10 (6.0)
Median Mayo score (IQR)  7 (7–8)
Median Mayo endoscopic score (IQR)  3 (3–3)
Extent of disease, n (%):   
   Proctitis 6 (3.6) 
   Left-sided colitis(distal colitis included) 58 (34.9)
   Pancolitis 102 (61.4)
 Indications for therapy with XELJANZ, n (%):   
   Naïve patients (first line) 6 (3.6)
   Failure of anti-TNFα treatment
   (second line)
71 (42.8)
   Failure of anti-TNFα plus anti-integrin
   or anti-IL 12/23 treatment (third line)
75 (45.2)
   Failure of anti-TNFα plus anti-integrin
   plus anti-IL 12/23 treatment 
   (fourth line)
14 (8.4)
Median creatine phosphokinase level, UI/L (IQR)  97.5 (80.0–121.0)​
Median cholesterol level, mg/dL (IQR) 176.0 (157.5–196.0)
Median LDL level, mg/dL (IQR)  105.0 (79.7–128.5)
Median triglycerides level, mg/dL (IQR)   112.0 (85.0–145.0)
Median CRP, mg/L (IQR)  7 (5–8)
Median calprotectin, µg/g (IQR) 821 (670–900)

 

Statistical analysis1
  • Continuous non-parametric vari­ables were examined as median (IQR)​

  • Categorical variables were examined as numbers (%) ​

  • Chi-square test was used to compare categorical variables​

  • Mann-Whitney test was used for continuous vari­ables​

  • Due to varying lengths of follow-up, the predictive value of clinical parameters was assessed using time-to-event methods for censored observations​

  • The duration of follow-up was calculated from the date of starting therapy to the date of the event or censorship​

  • Time-to-event analysis used Kaplan-Meier estimates for the cumulative incidence curves​

  • P-values of <0.05 were considered to be statistically significant

Study Limitations1
  • Retrospective nature of the study hindered consistent follow-up and uniform subgroups for the analysis​
    - No central reading on endoscopy or for the laboratory assessment​
    - Varying practices across different centers​
    - Mild AEs could be missed​
  • Specific geographic population may not be representative of the worldwide population (e.g., patient characteristics, healthcare access)​

  • There is no control or comparator population 

Publication Summary1

In a retrospective, observational, multicenter study of UC patients in Italy receiving XELJANZ treatment (N=166), with a median follow-up of 24 weeks:​

  • Clinical remission was achieved in 36.7% (61/166) and 45.2% (75/166) of patients at week 8 and at the end of follow-up, respectively​
  • AEs were reported in 5.4% patients, 6 cases were mild to moderate AEs and 3 cases were severe AEs
Scroll left to view table
Study Results1    CLINICAL REMISSION AT WEEK 8 AND AT THE END OF FOLLOW-UP
  • 36.7% of patients achieved clinical remission at week 8 follow-up​

  • Clinical remission was maintained by 45.2% of patients at the end of follow-up ​

  • Clinical remission was obtained by:
    -
    66.7% of patients naïve to biologic therapy (first-line therapya)​
    - 52.1% of patients who failed one or more anti-TNFα treatment (second-line therapya)​
    - 41.3% of patients who failed anti-TNFα and anti-integrin or anti-IL 12/23 treatment (third-line therapya)​
    - 21.4% of patients who failed anti-TNFα, anti-integrin and anti-IL 12/23 treatment (fourth-line therapya) ​

  • Lines of therapy may be predictors for clinical remission

    a: XELJANZ treatment was defined as first-, second-, third- or fourth-line therapy in this study. XELJANZ is categorised as first-line therapy when administered to biologic-naïve patients. In cases where patients exhibit resistance or refractoriness to steroids or have previously failed one or more anti-TNF-α treatments, XELJANZ is considered as second-line therapy. As for patients who have failed anti-TNF-α and anti-integrin or anti-IL12/23 treatments, XELJANZ is classified as third-line therapy. Finally, in situations where patients have experienced failure with anti-TNF-α,​ anti-integrin, and anti-IL12/23 treatments, XELJANZ is categorised as fourth-line therapy1.

Estimated cumulative clinical remission probability during follow-up by indications for therapy

Adapted from Tursi A, et al. Expert Opin Pharmacother. 2023:1–8.


 ENDOSCOPIC IMPROVEMENT DURING A FOLLOW-UP ​AT 24 WEEKS
  • Mucosal healinga was observed in 35/76 (46%) patientsb: ​
    -22/29 (75.9%) patients in clinical remission ​
    -13/47 (27.6%) patients without clinical remission
  • Complete endoscopic remissionc was achieved in 20/35 (57.1%) patients:​
    - 57.1% of patients with mucosal healing​
    - 26.3% of patients with endoscopic assessment during follow-up
  • 122/166 (73.5%) patients continued XELJANZ therapy during follow-up (median: 24 weeks ​[IQR 8–36])
  • The dosage optimisationd was requested overall in 27e/166 (16.3%) patients:

    - In none (0) of the patients treated with XELJANZ as first-line therapyf

    - In 9/27 (33.3%) patients treated as second linef

    - In 14/27 (51.9%) patients treated as third-linef

    - In 4/27 (14.8%) patients treated as fourth-line therapyf, (p=0.294, not statistically significant)

    a: Mucosal healing was defined as a Mayo subscore for endoscopy ≤1.1 
    b: P<0.000.1 
    c: Mayo score 0.1 
    d: Optimisation rate was considered as the persis­tence on 10 mg BID up to 8 weeks following the 8-week induction course, or increased from 5 mg to 10 mg BID during follow-up1
    e: XELJANZ was used in 12/27 (44.4%) patients resistant/refractory to steroid therapy.
    f: XELJANZ treatment was defined as first-, second-, third- or fourth-line therapy in this study. XELJANZ is categorised as first-line therapy when administered to biologic-naïve patients. In cases where patients exhibit resistance or refractoriness to steroids or have previously failed one or more anti-TNF-α treatments, XELJANZ is considered as second-line therapy. For patients who have failed anti-TNF-α and anti-integrin or anti-IL12/23 treatments, XELJANZ is classified as third-line therapy. Finally, in situations where patients have experienced failure with anti-TNF-α, anti-integrin, and anti-IL12/23 treatments, XELJANZ is categorised as fourth-line therapy1.


ADVERSE EVENT OUTCOME DURING A FOLLOW-UP AT 24 WEEKS
  • In 6/166 (3.6%) patients, AEs were mild to moderate and did not require treatment discontinuation:
    - One case of simplex herpes zostera,b
    - Two cases of gastrointestinal infectionc
  • In 3/166 (1.8%) patients, AEs were severe and required treatment withdrawal:
    -One case of renal vein thrombosisd
  • In most patients, cholesterol and triglyceride levels remained within the average values during follow-up:
    - 4/166 (2.4%) patients required treatment to maintain cholesterol within average valuese

    - A significantf,g mild and transient increase of CPK levels was observed during the study period: from a median value of 97.5 (80.0-121.0) UI/L at baseline to 128 (90.0-178.7) UI/L at week 8 and 119 (97.7-151.5) UI/L at 16-week follow-up 

    a: A single dermatome was involved, and the infection resolved within four weeks1
    b: This patient did not receive the herpes zoster vaccine, which was largely embraced by the population, with >95% enrollment, following the introduction of the recombinant vaccine in Italy in March 2021.1 
    c: Two cases of gastrointestinal infection were Clostridioides difficile and Campylobacter coli. Both cases were treated with oral antibiotic therapy without XELJANZ discontinuation1
    d: This case of renal vein thrombosis occurred in a 19-year-old female patient with a long-lasting history of steroid-resistant pancolitis, failure to infliximab and vedolizumab, and under concomitant treatment with azathioprine 100 mg and corticosteroids. This AE occurred after approximately seven weeks of XELJANZ therapy and was associated with severe clinical worsening of her colitis and hospitalisation. It resolved after initiating anticoagulation therapy, and no further complications occurred after discharge1
    e: Two patients treated with statins, one with a low-fat diet, and one with nutraceutical treatment1
    f: Friedman test1
    g: P<0.0061
     

Explore MoreRegulatory Updates for JAK inhibitors with James Galloway

Visit the page to gain more insight into the updated regulatory guidance on JAK inhibitors from an expert rheumatologist's perspective

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TOUR Registry

Learn more about real-world evidence in UC: TOUR Registry

Next PageLoading

UC: ulcerative colitis; IQR:Interquatile range; anti-IL=anti-interleukin; anti-TNFα=anti-tumor necrosis factor alpha; CRP=C-reactive protein; LDL=low-density lipoprotein; AE: Adverse Event; CPK=creatine phosphokinase; MACE=major cardiovascular adverse events; VTE=venous thrombosis event. ​

References

1. Tursi A, et al. Expert Opin Pharmacother. 2023:1–8.

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-4942. May 2024
Real-World Evidence: UCORAL Surveillance study in Ulcerative Colitis | Professor Charlie LeesIn this video, Professor Charlie Lees, consultant gastroenterologist at the Edinburgh IBD Unit talks about the ORAL Surveillance study and its implications for the use of tofacitinib in the treatment of ulcerative colitis. He offers an overview of the study design and a summary of the results, before offering his own clinical interpretation and how this affects his prescribing decisions specifically with UC patients.

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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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