XELJANZ® (tofacitinib citrate) PBS-listed for patients aged 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA)

• XELJANZ is the first and only oral medicine approved in Australia for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA)¹
• Juvenile idiopathic arthritis, which includes pcJIA, is one of the most common chronic childhood diseases in Australia, occurring in around 1 in 500 children^2,3
• The availability of XELJANZ on the PBS provides subsidised access to a new mode of action (Janus kinase (JAK) inhibitor), in the form of an oral treatment option for active pcJIA, offering relief for patients with needle phobia and their caregivers¹

SYDNEY, AUSTRALIA 11 DECEMBER 2023 — Pfizer Australia has welcomed the announcement that XELJANZ (tofacitinib) will be listed on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 December, for the treatment of patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis (pcJIA), who have responded inadequately to previous therapy with disease-modifying antirheumatic drugs (DMARDs),⁴ a group of medications commonly used in people living with inflammatory forms of arthritis. 

XELJANZ is an oral medicine classified as a JAK (Janus kinase) inhibitor. The active ingredient, tofacitinib, limits the activation of the immune system that is involved in auto-immune conditions, such as pcJIA and other inflammatory conditions.⁴

Juvenile idiopathic arthritis is one of the most common chronic childhood diseases in Australia, occurring in around 1 in 500 children.^2,3 The inflammatory disease is characterised by ‘flares’, which cause significant joint pain, and can restrict a child's ability to engage in age-appropriate activities, impacting their physical, social, and emotional wellbeing.^5,6

“The availability of XELJANZ on the PBS offers subsidised access to the first and only Janus kinase (JAK) inhibitor approved in Australia for the treatment of pcJIA, in two formulations, a tablet and an oral solution – giving clinicians additional treatment options for their patients,” said Dr Jeff Chaitow, Head of Rheumatology at The Children’s Hospital Westmead.

“Many patients, living with juvenile idiopathic arthritis, require injections or infusions as part of their treatment, which can present challenges for children and their caregivers. This listing represents a significant advancement and offers relief for needle phobic patients and reduces the treatment burden,” Dr Chaitow said.

The reimbursement of XELJANZ reflects Pfizer’s ongoing effort to bring innovative treatments to market for Australian patients.

Associate Professor Ruth Colagiuri, founder of the Juvenile Arthritis Foundation Australia (JAFA), whose grandchild is living with arthritis, said the announcement was great news for the community.

“Eighty percent of children with juvenile arthritis endure daily pain, leading to limited physical activities, increased risk of mental and physical health issues, social isolation, and disengagement from education,”² said Associate Professor Colagiuri.

“Juvenile arthritis is one of the most under-recognised, misunderstood, and neglected childhood diseases in Australia. For children and their families affected, managing the condition can be complex, expensive and take a psychological, social and economic toll,” Associate Professor Colagiuri said.

Anne Harris, Pfizer Australia & New Zealand Managing Director, said the listing is an important step forward in delivering breakthrough medicines to patients and clinicians and demonstrates Pfizer’s expertise in JAK science.

“We thank the Australian Government for acknowledging the importance of providing additional solutions to individuals living with polyarticular course juvenile idiopathic arthritis and their families and we are proud to offer XELJANZ to this patient community,” Ms Harris said.

For more information about juvenile arthritis, please visit the Juvenile Arthritis Foundation Australia (JAFA) website: https://www.jafa.org.au/about/juvenile-arthritis/

Video news release (VNR), available here: https://spaces.hightail.com/space/WGPlq7uQD2

This medicine is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Patients can help by reporting any side effects they may get. Patients can report side effects to their doctor, or directly at www.tga.gov.au/reporting-problems. 

About XELJANZ

XELJANZ contains the active ingredient tofacitinib. Tofacitinib belongs to a group of medicines called Janus Kinase (JAK) inhibitors. It works by reducing the activity of the enzyme Janus Kinase, which helps to reduce inflammation. 

INDICATIONS: Treatment of moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or are intolerant to methotrexate; used alone or in combination with conventional synthetic disease-modifying antirheumatic drugs (DMARDs), including methotrexate. Treatment of active psoriatic arthritis in adult patients who have had an inadequate response to a prior DMARD therapy, in combination with conventional synthetic DMARDs. Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy. Treatment of adult patients with active ankylosing spondylitis who have responded inadequately to conventional therapy. Treatment of active polyarticular course juvenile idiopathic arthritis (rheumatoid factor positive [RF+] or negative [RF-] polyarthritis, extended oligoarthritis and systemic juvenile arthritis without systemic features for six months) and juvenile psoriatic arthritis in patients 2 years of age and older, who have responded inadequately to previous therapy with DMARDs.  

DOSAGE AND ADMINISTRATION: Refer to ‘Recommended Dosage in polyarticular course Juvenile Idiopathic Arthritis (pcJIA) for indication-specific dosing instructions and to Table 2 in the PI for dosage adjustments. 

CONTRAINDICATIONS: Hypersensitivity to tofacitinib citrate or to any of the excipients. Must not be used in combination with biological agents or other potent immunosuppressive agents. XELJANZ should not be used in patients with severe hepatic impairment.  

WARNINGS & PRECAUTIONS: Therapy with XELJANZ should be initiated and monitored by a specialist physician with expertise in the management of conditions for which XELJANZ and XELJANZ XR are indicated (e.g., rheumatologist or gastroenterologist). Dose-dependent adverse reactions seen in patients treated with XELJANZ 10 mg twice daily, in comparison to 5 mg twice daily include the following: herpes zoster infections, serious infections, non-melanoma skin cancer (NMSC), higher rate of all-cause mortality and thrombosis. 

INTERACTIONS WITH OTHER MEDICINES: Since tofacitinib is metabolised by CYP3A4, interaction with medicinal products that inhibit or induce CYP3A4 is likely. Tofacitinib exposure is increased when co-administered with potent inhibitors of CYP3A4 (e.g., ketoconazole) or when administration of one or more concomitant medications result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole). Tofacitinib exposure is decreased when co-administered with potent CYP3A4 inducers (e.g., rifampicin). Inhibitors of CYP2C19 alone or P-glycoprotein are unlikely to significantly alter the pharmacokinetics (PK) of tofacitinib.  

For a copy of the CMI for XELJANZ please ask your healthcare professional or view online at XELJANZ (tofacitinib) | Pfizer Medical Information - Australia.