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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.

ORAL Strategy Safety Outcomes

  • AE rates, including rates of the most common AEs, were comparable between treatment arms.1
  • The majority of AEs were mild or moderate in severity.1

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 Fleischmann R et al. 2017.1

Safety analysis set was identical to the full analysis set. Two (1%) of patients receiving XELJANZ monotherapy died during the first year of therapy.1

*Patients could have experienced more than one AE.1

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Safety & Tolerability

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

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AE, adverse event; BID, twice-daily; MTX, methotrexate; Q2W, once every 2 weeks; SAE, serious adverse event. ​​​​​​​

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PP-XEL-GBR-3116. August 2021

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

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*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

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