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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

For UK Healthcare Professionals*

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PP-PFE-GBR-2688. December 2020

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