Tofacitinib Pfizer

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HomeAboutTofacitinib Pfizer Mechanism of ActionEfficacyClinical Efficacy RARapid Data (ACR20)Head-to-Head Noninferiority Data (ACR50)Clinical Efficacy PsAACR20 DataPASI75 DataEnthesitis and Dactylitis DataClinical Efficacy ASASAS20/40 DataASDAS(CRP) DataClinical Efficacy UC8-Week EfficacyOnset of Action Data52-Week EfficacyOCTAVE Study DesignSafetyImportant Safety InformationSafety and TolerabilitySafety in RASafety in PsASafety in UCSafety in ASDosingDosing in RADosingPractical ConsiderationsDosing in PsADosingPractical ConsiderationsDosing in ASDosingPractical ConsiderationsDosing in UCDosingPractical ConsiderationsMedical InformationVisit the Pfizer Medical Information Africa Website for Healthcare ProfessionalsSubmit a medical question to Pfizer

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Safety in AS, including ORAL Surveillance postmarketing dataORAL Surveillance (Study A3921133)1

In a phase IIIb/IV randomized, open-label, noninferiority, postauthorization safety, endpoint-driven study among patients 50 years of age or older with moderate to severe RA, with at least one additional CV risk factor and taking MTX without adequate control of symptoms1:

  • The coprimary endpoints were adjudicated MACEa and adjudicated malignancies (excluding NMSC)1
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  • ​​​​​​​For adjudicated MACE and adjudicated malignancies (excluding NMSC), the prespecified noninferiority criterion was not met for the primary comparison of the combined tofacitinib doses to TNFi1,b​​​​​​​​​​​​​
For more information on the ORAL Surveillance study, click here.
​​​​​​​MACE defined as cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.1The noninferiority criterion was not met for the primary comparison of the combined tofacitinib doses to TNFi since the upper limit of the 95% CI exceeded the prespecified noninferiority criterion of 1.8 (ie, for MACE: 1.94>1.8, for malignancy: 2.09>1.8).1RA and PsA integrated safety summary (ISS)Limitations of pooled and long-term extension (LTE) data2
  • Pooled, post hoc analysis of studies from the RA clinical trial program are subject to certain limitations. First, unlike ORAL Surveillance, the patient population is not limited to a high-risk population but includes all enrolled patients. Second, endpoints of interest (such as MACE and malignancy for ORAL Surveillance) were not all specifically defined or adjudicated. Additionally, ORAL Surveillance was a long-term safety study (vs RCT phase 3 which are short term and designed to test efficacy). Resultant incidence rates in ORAL Surveillance differed from rates seen from pooled study data, suggesting the pooled data may be obscuring information about predictors of events given adverse rates may differ from one patient population to another and may change over time
  • LTE studies may provide useful data, however, conduct of open-label LTE studies where both treatment and dose are known to both investigator and patient is subject to certain biases and limitations. Most participants were known to have responded to, and tolerated, Tofacitinib Pfizer (all had completed a qualifying study), hence our findings might not be generalizable to patients new to Tofacitinib Pfizer
  • Biases include, but are not limited to, patient selection (patient willingness or ineligibility to enroll, which may be due to a prior serious AE), prior treatment, volunteer, observer, initial dose or study drug, investigator/patient expectation and study duration. Limitations include, but are not limited to, AE frequencies and incidence rates subject to change over time due to patient entry/exit, dose changes influenced by both investigator and patient, dose restrictions in certain countries, the number of patients and exposure for a specific safety event possibly differing depending on the timing of censored events, and the number of observed patients with longer exposure times becoming lower
RA and PsA ISS: Baseline characteristics and demographics3​​​​​​​
  • The ISS and analysis of adverse events of special interest includes pooled data from patients exposed to ≥1 dose of Tofacitinib Pfizer in phase 1, 2, 3, or 3b/4 clinical trials, and LTE studies in RA and phase 3 clinical trials and LTE studies in PsA3
  • In LTE studies, dose adjustments for Tofacitinib Pfizer or concomitant medications were allowed at the investigator’s discretion for efficacy or safety reasons3
All doses in RA included Tofacitinib Pfizer 1 mg, 3 mg, 5 mg, 10 mg, 15 mg, 30 mg BID; 10 mg or 20 mg QD; or 11 mg MR QD.4Tofacitinib Pfizer 5 mg BID or 11 mg prolonged release QD are the only approved dosages for the treatment of RA and PsA, which should not be exceeded. 10 mg BID is not licensed for RA or PsA.5  All doses in PsA included Tofacitinib Pfizer 5 mg and 10 mg BID.4Adverse events of special interest in the RA (excluding 1133) and PsA clinical trial programsOverall, the safety profile observed in patients with active AS treated with Tofacitinib Pfizer was consistent with the safety profile observed in patients with RA and PsA treated with Tofacitinib Pfizer.5
  • The ISS and analysis of adverse events of special interest includes pooled data from patients exposed to ≥1 dose of Tofacitinib Pfizer in phase 1, 2, 3, or 3b/4 clinical trials, and LTE studies in RA and phase 3 clinical trials and LTE studies in PsA3
  • In LTE studies, dose adjustments for Tofacitinib Pfizer or concomitant medications were allowed at the investigator’s discretion for efficacy or safety reasons3
Final data for the RA and PsA cohorts are from April 18, 2019, and July 31, 2019, respectively.3 All doses in RA included Tofacitinib Pfizer 1 mg, 3 mg, 5 mg, 10 mg, 15 mg, 30 mg BID; 10 mg or 20 mg QD; or 11 mg MR QD.4 Tofacitinib Pfizer 5 mg BID or 11 mg prolonged release QD are the only approved dosages for the treatment of RA and PsA, which should not be exceeded. 10 mg BID is not licensed for RA or PsA.5 All doses in PsA included Tofacitinib Pfizer 5 mg and 10 mg BID.4 Adjudicated events.3 ​​​​​​​Composite MACE defined as any myocardial infarction, stroke, or cardiovascular death.3​​​​​​​Study AS-I: Baseline characteristics and demographics​​​​​​​7One patient did not take prior NSAIDs due to medical history.7​​​​​​​Patients designated as TNFi-IR must have had an IR to at least one, but not more than two, approved TNFi.7Safety data in study AS-I7 Overall, the safety profile observed in patients with active AS treated with Tofacitinib Pfizer was consistent with the safety profile observed in patients with RA and PsA treated with Tofacitinib Pfizer.5Most common AEs by preferred term (occurring in >5% of any treatment group)7 AEs of special interest7 ​​​​​​​One Tofacitinib Pfizer-treated AS patient experienced 1 SI event (meningitis).7 All cases were nonserious.7 Adjudicated events.7 Composite MACE defined as any myocardial infarction, stroke, or cardiovascular death.3 ​​​​​​​Two sequential AST or ALT ≥3×ULN; unrelated DILI; patient did not meet criteria for potential Hy’s law or definite Hy’s law.7 ​​​​​​​One patient had 2 sequential AST or ALT ≥3×ULN, which was unrelated DILI; 1 patient had AST or ALT ≥5×ULN, which was unlikely DILI; 1 patient had cholecystitis and recurrence of gallstones, which was unrelated DILI. None of these patients met the criteria for potential Hy’s law nor definite Hy’s law.7 
This safety analysis consisted of patients who received at least 1 dose of study drug.7 Explore more Dosing and administration in AS See recommended dosing Loading
AE=adverse event; ALT=alanine aminotransferase; AS=ankylosing spondylitis; ASAS=Assessment of SpondyloArthritis international Society; AST=aspartate aminotransferase; ATE=arterial thromboembolism; bDMARD=biologic disease-modifying antirheumatic drug; BID=twice daily; BMI=body mass index; CRP=C-reactive protein; CV=cardiovascular; DILI=drug-induced liver injury; DVT=deep vein thrombosis; GI=gastrointestinal; hsCRP=high-sensitivity C-reactive protein; HZ=herpes zoster; ILD=interstitial lung disease; IR=inadequate response; JAKi=Janus kinase inhibitor; JIA=juvenile idiopathic arthritis; MACE=major adverse cardiovascular event; MR=modified release; MTX=methotrexate; NMSC=nonmelanoma skin cancer; NSAID=nonsteroidal anti-inflammatory drug; PE=pulmonary embolism; PsA=psoriatic arthritis; pt-yr=patient year; QD=once daily; RA=rheumatoid arthritis; RCT=randomized controlled trial; SD=standard deviation; TB=tuberculosis; TNFi=tumor necrosis factor inhibitor; UC=ulcerative colitis; ULN=upper limit of normal; URTI=upper respiratory tract infection; VTE=venous thromboembolism.References:Ytterberg SR, Bhatt DL, Mikuls TR, et al. Cardiovascular and cancer risk with tofacitinib in rheumatoid arthritis. N Engl J Med. 2022;386(4):316-326.Data on file. PfizerBurmester GR, Nash P, Sands BE, et al. Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and psoriasis with 37 066 patient-years of tofacitinib exposure. RMD Open. 2021;7:e001595. doi:10.1136/rmdopen-2021-001595Burmester GR, Nash P, Sands BE, et al. Adverse events of special interest in clinical trials of rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and psoriasis with 37 066 patient-years of tofacitinib exposure. [supplementary appendix]. RMD Open. 2021;7(2):1-36.Tofacitinib Pfizer [summary of product characteristics]. PfizerMease P, Charles-Schoeman C, Cohen S, et al. Incidence of venous and arterial thromboembolic events reported in the tofacitinib rheumatoid arthritis, psoriasis and psoriatic arthritis development programmes and from real-world data. Ann Rheum Dis. 2020;79(11):1400-1413.Deodhar A, Sliwinska-Stanczyk P, Xu H, et al. Tofacitinib for the treatment of ankylosing spondylitis: a phase III, randomised, double-blind, placebo-controlled study. Ann Rheum Dis. 2021;80(8):1004-1013.
Safety and Tolerability
EFFICACY

Have you seen how Tofacitinib Pfizer performed when evaluated against ASAS20 and ASAS40 criteria?

See AS data

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