• Moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to methotrexate. Xeljanz can be initiated as monotherapy or in combination with methotrexate (MTX) or other nonbiologic disease modifying anti-rheumatic drugs (DMARDs). Xeljanz should not be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.

• Diagnosis of rheumatoid arthritis (RA)

AND

• Confirmed by a Rheumatologist

OR

• Defined at baseline prior to disease-modifying anti-rheumatic drug (DMARD) treatment initiation by the American College of Rheumatology (ACR) criteria (refer to General Information for ACR criteria)

AND

• Failure or clinically significant adverse effects to methotrexate (MTX) in the last year for patients who are new to biologics

OR

• If patient is not a candidate for MTX (i.e. patient is a smoker [increased risk of MTX lung disease] or MTX is contraindicated), then failure or clinically significant adverse effects to sulfasalazine or 1 other DMARD

• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and usage guidelines section unless there is sufficient documentation of efficacy and safety in the published literature.
• Combination use with biological DMARDs such as TNF antagonists [Enbrel, Cimzia, Humira, Simponi, Remicade], interleukin-1 receptor (IL-1R) antagonists [Kineret], interleukin-6 receptor (IL-6R) antagonists [Actemra], anti-CD20 monoclonal antibodies [Rituxan] and selective co-stimulation modulators [Orencia] or potent immunosuppressants [azathioprine, cyclosporine] because of the possibility of increased immunosuppression, neutropenia and increased risk of infection.

• ACR Classification criteria for RA (score-based algorithm: add score of categories A-D; a score of >/= 6/10 is needed for classification of a patient as having definite RA).

A. Joint involvement (swollen or tender)

• 1 large joint, score = 0
• 2-10 large joints, score = 1
• 1-3 small joints (with or without involvement of large joints), score = 2
• 4-10 small joints (with or without involvement of large joints), score = 3
• >10 joints (at least 1 small joint), score = 5

B. Serology (at least 1 test result is needed for classification)

• Negative RF (rheumatoid factor) and negative ACPA (anti-citrullinated protein antibody), score = 0
• Low-positive RF orlow-positive ACPA, score = 2
• High-positive RF orhigh-positive ACPA, score = 3

C. Acute-phase reactants (at least 1 test result is needed for classification)

• Normal CRP (C-reative protein) and normal ESR (erythrocyte sedimentation rate), score = 0
• Abnormal CRP or abnormal ESR, score = 1

D. Duration of symptoms

• < 6 weeks, score = 0
• >/= 6 weeks, score = 1

• In RA, failure of MTX or DMARD is defined as a contraindication or < 50% decrease in swollen joint count, < 50% decrease in tender joint count, and < 50% decrease in ESR, or < 50% decrease in CRP, or contraindication to at least 3 months of therapy with MTX at doses up to 25 mg per week or maximum tolerated dose.
• Serious infections leading to hospitalization or death (e.g. tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections) have occurred in patients receiving Xeljanz. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Xeljanz should not be used in combination with biologic DMARDs or potent immunosuppressants such as azathioprine and cyclosporine.
• Do not administer Xeljanz during an active infection, including localized infections. If a serious infection develops, interrupt Xeljanz until the infection is controlled.
• Lymphoma and other malignancies have been observed in patients treated with Xeljanz. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with Xeljanz and concomitant immunosuppressive medications. Consider the risks and benefits of Xeljanz treatment prior to initiating therapy in patients with a known malignancy.
• Laboratory monitoring is recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.

1. Xeljanz [Prescribing information]. New York, NY: Pfizer Labs. May 2014.
2. Aletaha D, Neogi T, Silman AJ et al. 2010 Rheumatoid Arthritis Classification Criteria. Arthritis and Rheumatism. September 2010:62(9):2569-2581.
3. Singh J, Furst D, Bharat A, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care & Research. May 2012;64(5):625-639.
4. Van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med. 2012;367:508-519.
5. Fleischmann R, Kremer J, Cush J, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med. 2012;367:495-507.