This site contains promotional information intended only for healthcare professionals resident in the United Kingdom
Sign in
Sign in
Sign out

Information relating to specific disease areas aligned to Pfizer’s portfolio and other resources designed for Pfizer medicines.

See all Therapy areas

Explore Content

About

Efficacy

Safety & Tolerability

Real World Experience

Support & Resources

Information on how to access XELJANZ®▼ (tofacitinib citrate) prescribing information and adverse event reporting can be found at the bottom of the page.

JIA-1 Safety Outcomes

  • In Study JIA-I, adverse reactions included infections (influenza, pharyngitis, sinusitis, viral infection) and gastrointestinal disorders or general disorders (abdominal pain, nausea, vomiting, pyrexia, headache, cough).1 
  • There were no cases of MACE, malignancies (including NMSC), mortality, or thrombotic events (DVT, PE, or ATE) in Study JIA-I.2
  • Serious infections in XELJANZ patients in Study JIA-I included appendicitis, epidural empyema (with sinusitis and subperiosteal abscess), pilonidal cyst, pneumonia, escherichia pyelonephritis, limb abscess, and UTI.1
Safety analysis set included all JIA subtypes recruited to the study (pcJIA, PsA and ERA)

XELJANZ 5mg BID (n=384)

XELJANZ 5mg BID + MTX (n=376)

Adalimumab 40mg Q2W + MTX (n=386)

Total number of AEs, n*

598

652

620

Patients with AEs, n (%)

226 (59)

231 (61)

253 (66)

Patients with treatment-related AEs, n (%)

101 (26)

111 (30)

133 (35)

Patients with SAEs, n (%)

35 (9)

27 (7)

24 (6)

Patients discontinuing due to AEs, n (%)

23 (6)

26 (7)

37 (10)

Total number of AEs, n*

XELJANZ 5mg BID (n=384)

598

XELJANZ 5mg BID + MTX (n=376)

652

Adalimumab 40mg Q2W + MTX (n=386)

620

Patients with AEs, n (%)

XELJANZ 5mg BID (n=384)

226 (59)

XELJANZ 5mg BID + MTX (n=376)

231 (61)

Adalimumab 40mg Q2W + MTX (n=386)

253 (66)

Patients with treatment-related AEs, n (%)

XELJANZ 5mg BID (n=384)

101 (26)

XELJANZ 5mg BID + MTX (n=376)

111 (30)

Adalimumab 40mg Q2W + MTX (n=386)

133 (35)

Patients with SAEs, n (%)

XELJANZ 5mg BID (n=384)

35 (9)

XELJANZ 5mg BID + MTX (n=376)

27 (7)

Adalimumab 40mg Q2W + MTX (n=386)

24 (6)

Patients discontinuing due to AEs, n (%)

XELJANZ 5mg BID (n=384)

23 (6)

XELJANZ 5mg BID + MTX (n=376)

26 (7)

Adalimumab 40mg Q2W + MTX (n=386)

37 (10)

Adapted from Ruperto et al, 2021.2​​​​​​​

*XELJANZ 5 mg BID or equivalent weight based lower dose in patients <40 kg.1
†Adjudicated events.2
‡Both nonserious. 2
§One SAE of pilonidal cyst repair was coded to surgical procedures instead of infections, and was inadvertently not identified as a serious
infection. Following adjudication, the serious AE did not meet opportunistic infection criteria; it is also included in the table as a
serious infection. 2

PLEASE SEE XELJANZ SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION

Explore more​​​​​​​​​​​​

Safety & Tolerability

Please click here for an overview of the safety profile of XELJANZ across all licensed indications.

Learn more


AE, adverse event; ATE, arterial thromboembolism; BID, twice daily; DVT, deep vein thrombosis; ERA, enthesitis-related arthritis; GI, gastrointestinal; ILD, interstitial lung disease; MACE, major adverse cardiovascular event; NMSC, nonmelanoma skin cancer; pcJIA, polyarticular course juvenile idiopathic arthritis; PE, pulmonary embolism; PsA, psoriatic arthritis; SAE, serious adverse event; UTI, urinary tract infection.
​​​​​​

PP-XEL-GBR-3391. January 2022

Announcement Title

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.

Clinical Efficacy RA

For UK Healthcare Professionals*

These pages are not intended for patients or for members of the general public. The healthcare professional web pages contain promotional content.

I confirm that I am a healthcare professional* resident in the United Kingdom.

If you select 'No', you will be redirected to Pfizer.co.uk where you will be able to access reference information on Pfizer's prescription medicines.

*The ABPI Code definition for healthcare professional is members of the medical, dental, pharmacy and nursing professionals and any other persons who in the course of their professional activities may administer, prescribe, purchase, recommend or supply a medicine.

PP-PFE-GBR-3863. November 2021

Yes

No