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  • PsA: Efficacy data

    ACR20/50/70 response rates 

    Significant ACR20/50/70 response rates vs placebo at month 31,2,a

    OPAL Broaden (Study PsA-I) in csDMARD-IR patients1,2

    Study PsA-I was not designed to demonstrate noninferiority or superiority of XELJANZ to adalimumab.1
    *P≤0.05 vs placebo2
    ​​​​​​​P≤0.05 vs placebo, nominal P values not adjusted for multiplicity. Results need cautious interpretation and could represent chance findings.3
    aNonresponder imputation was applied to missing sign/symptom data.1,2

    OPAL Broaden (Study PsA-I) study design

    A 12-month, randomized, double-blind, double-dummy, active-controlled, placebo-controlled, multicenter, phase 3 trial in which 422 adult patients with active PsA who had inadequate response to at least one csDMARD and were TNFi-naïve received either XELJANZ 5 mg BID, 10 mg BID, adalimumab 40 mg SC q 2 wk, or placebo. At month 3, all patients randomized to placebo were advanced to XELJANZ 5 mg BID or 10 mg BID in a blinded manner based on their initial randomization sequence (XELJANZ 10 mg BID is not approved for PsA). Across all treatment arms, all patients were required to receive a stable dose of one csDMARD (also known as a nonbiologic DMARD, which included methotrexate, sulfasalazine, and leflunomide). Stable low-dose oral glucocorticoids were allowed. The primary endpoints were ACR20 response rate and change from baseline in HAQ-DI score at month 3. To control for type I error at the 5% level for primary and certain secondary endpoints, statistical testing was performed for XELJANZ in a hierarchical sequence and was stopped at any point wherever statistical significance was not reached. Study PsA-I was not designed to demonstrate noninferiority or superiority of XELJANZ to adalimumab. XELJANZ/XELJANZ XR is not indicated for the treatment of plaque psoriasis.1-3

    ACR=American College of Rheumatology; BID=twice daily; csDMARD=conventional synthetic disease-modifying antirheumatic drug; DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire–Disability Index; PsA=psoriatic arthritis; q 2 wk=every 2 weeks; SC=subcutaneously; TNFi=tumor necrosis factor inhibitor.
    References:
    1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc., October 2020. 
    2. Data on file. Pfizer Inc., New York, NY.
    3. Mease P, Hall S, FitzGerald O, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. N Engl J Med. 2017;377(16):1537-1550.

    OPAL Broaden (Study PsA-I) patient characteristics

    Select inclusion criteria1

    • ≥18 years of age, had diagnosis of PsA for ≥6 months, and fulfilled Classification Criteria for Psoriatic Arthritis (CASPAR) at screening 
    • Active arthritis (at least 3 tender/painful joints and at least 3 swollen joints) at both screening and baseline, and active plaque psoriasis at screening (no criteria for minimum severity)
    • Inadequate response to at least one csDMARD
    • TNFi-naïve

    Select exclusion criteria1

    • Current nonplaque forms of psoriasis (nail psoriasis permitted)
    • Prior treatment with a non–B-cell specific lymphocyte-depleting agent
    • History of any autoimmune rheumatic disease other than psoriatic arthritis

    Select demographic and disease characteristics of patients at baseline (mean values)2

    XELJANZ 5 mg BID
    (n=107)

    Placebo
    (n=105)

    Adalimumab 40 mg SC q 2 wk (n=106)

    Age (years)

    49.4

    47.7

    47.4

    Duration of PsA (years)

    7.3

    6.4

    5.3

    HAQ-DI score

    1.2

    1.1

    1.1

    Leeds Enthesitis Index score

    2.5

    2.8

    2.3

    Dactylitis Severity Score

    9.1

    9.9

    8.0

    Swollen joint count

    12.9

    11.5

    9.8

    Tender or painful joint count

    20.5

    20.6

    17.1

    Elevated high-sensitivity CRP level (defined as >2.87 mg/L)

    64%

    60%

    60%

    Modified Total Sharp Score

    17.1

    17.6

    14.4

    Select demographic and disease characteristics of patients at baseline (mean values)

    XELJANZ 5 mg BID
    (n=107)

    Age (years)

    49.4

    Duration of PsA (years)

    7.3

    HAQ-DI score

    1.2

    Leeds Enthesitis Index score

    2.5

    Dactylitis Severity Score

    9.1

    Swollen joint count

    12.9

    Tender or painful joint count

    20.5

    Elevated high-sensitivity CRP level (defined as >2.87 mg/L)

    64%

    Modified Total Sharp Score

    17.1

    Select demographic and disease characteristics of patients at baseline (mean values)

    Placebo
    (n=105)

    Age (years)

    47.7

    Duration of PsA (years)

    6.4

    HAQ-DI score

    1.1

    Leeds Enthesitis Index score

    2.8

    Dactylitis Severity Score

    9.9

    Swollen joint count

    11.5

    Tender or painful joint count

    20.6

    Elevated high-sensitivity CRP level (defined as >2.87 mg/L)

    60%

    Modified Total Sharp Score

    17.6

    Select demographic and disease characteristics of patients at baseline (mean values)

    Adalimumab 40 mg SC q 2 wk (n=106)

    Age (years)

    47.4

    Duration of PsA (years)

    5.3

    HAQ-DI score

    1.1

    Leeds Enthesitis Index score

    2.3

    Dactylitis Severity Score

    8.0

    Swollen joint count

    9.8

    Tender or painful joint count

    17.1

    Elevated high-sensitivity CRP level (defined as >2.87 mg/L)

    60%

    Modified Total Sharp Score

    14.4

    ​​​​​​​BID=twice daily; CRP=C-reactive protein; csDMARD=conventional synthetic disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire–Disability Index; PsA=psoriatic arthritis; q 2 wk=every 2 weeks; SC=subcutaneously; TNFi=tumor necrosis factor inhibitor.
    References:
    1. Mease P, Hall S, FitzGerald O, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis [supplementary appendix]. N Engl J Med. 2017;377(16):1537-1550. Accessed September 8, 2020. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1615975/suppl_file/nejmoa1615975_appendix.pdf
    2. Mease P, Hall S, FitzGerald O, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. N Engl J Med. 2017;377(16):1537-1550.

    Significant ACR20/50 response rates vs placebo at month 31,4,a

    OPAL Beyond (Study PsA-II) in TNFi-IR patients1,4

    *P≤0.05 vs placebo4
    aNonresponder imputation was applied to missing sign/symptom data.1,4

    OPAL Beyond (Study PsA-II) study design​​​​​​​

    A 6-month, randomized, double-blind, placebo-controlled, multicenter, phase 3 trial in which 394 adult patients with active PsA who had inadequate response to at least one TNFi received either XELJANZ 5 mg BID, 10 mg BID, or placebo. At month 3, all patients randomized to placebo were advanced to XELJANZ 5 mg BID or 10 mg BID in a blinded manner based on their initial randomization sequence (XELJANZ 10 mg BID is not approved for PsA). Across all treatment arms, all patients were required to receive a stable dose of one csDMARD (also known as a nonbiologic DMARD, which included methotrexate, sulfasalazine, and leflunomide). Stable low-dose oral glucocorticoids were allowed. The primary endpoints were ACR20 response rate and change from baseline in HAQ-DI score at month 3. To control for type I error at the 5% level for primary and certain secondary endpoints, statistical testing was performed for XELJANZ in a hierarchical sequence and was stopped at any point wherever statistical significance was not reached. XELJANZ/XELJANZ XR is not indicated for the treatment of plaque psoriasis.1-3​​​​​​​

    ACR=American College of Rheumatology; BID=twice daily; csDMARD=conventional synthetic disease-modifying antirheumatic drug; DMARD=disease-modifying antirheumatic drug; HAQ-DI=Health Assessment Questionnaire–Disability Index; PsA=psoriatic arthritis; TNFi=tumor necrosis factor inhibitor.​​​​​​​
    References:
    1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc., October 2020. 
    2. Data on file. Pfizer Inc., New York, NY. 
    3. Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med. 2017;377(16):1525-1536.

    Select inclusion criteria1

    • ≥18 years of age, had diagnosis of PsA for ≥6 months, and fulfilled Classification Criteria for Psoriatic Arthritis (CASPAR) at screening 
    • Active arthritis (at least 3 tender/painful joints and at least 3 swollen joints) at both screening and baseline, and active plaque psoriasis at screening (no criteria for minimum severity)
    • Inadequate response to at least one TNFi

    Select exclusion criteria1

    • Current nonplaque forms of psoriasis (nail psoriasis permitted)
    • Prior treatment with a non–B-cell specific lymphocyte-depleting agent
    • History of any autoimmune rheumatic disease other than psoriatic arthritis

    OPAL Beyond (Study PsA-II) patient characteristics

    Select demographic and disease characteristics of patients at baseline (mean values)2

    XELJANZ 5 mg BID
    (n=131)

    Placebo
    (n=131)

    Age (years)

    49.5

    49.0

    Duration of PsA (years)

    9.6

    9.4

    HAQ-DI score

    1.3

    1.3

    Leeds Enthesitis Index score

    3.0

    2.8

    Dactylitis Severity Score

    7.8

    6.8

    Swollen joint count

    12.1

    10.5

    Tender or painful joint count

    20.5

    19.8

    Elevated high-sensitivity CRP level (defined as >2.87 mg/L)

    65%

    61%

    Previous use of other biologic agents in addition to TNFi

    8%

    8%

    Select demographic and disease characteristics of patients at baseline (mean values)

    XELJANZ 5 mg BID
    (n=131)

    Age (years)

    49.5

    Duration of PsA (years)

    9.6

    HAQ-DI score

    1.3

    Leeds Enthesitis Index score

    3.0

    Dactylitis Severity Score

    7.8

    Swollen joint count

    12.1

    Tender or painful joint count

    20.5

    Elevated high-sensitivity CRP level (defined as >2.87 mg/L)

    65%

    Previous use of other biologic agents in addition to TNFi

    8%

    Select demographic and disease characteristics of patients at baseline (mean values)

    Placebo
    (n=131)

    Age (years)

    49.0

    Duration of PsA (years)

    9.4

    HAQ-DI score

    1.3

    Leeds Enthesitis Index score

    2.8

    Dactylitis Severity Score

    6.8

    Swollen joint count

    10.5

    Tender or painful joint count

    19.8

    Elevated high-sensitivity CRP level (defined as >2.87 mg/L)

    61%

    Previous use of other biologic agents in addition to TNFi

    8%

    BID=twice daily; CRP=C-reactive protein; HAQ-DI=Health Assessment Questionnaire–Disability Index; PsA=psoriatic arthritis; TNFi=tumor necrosis factor inhibitor.
    References:
    1. Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors [supplementary appendix]. N Engl J Med. 2017;377(16):1525-1536. Accessed September 8, 2020. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1615977/suppl_file/nejmoa1615977_appendix.pdf
    2. Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med. 2017;377(16):1525-1536.

    ACR20 response rates over time

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    Dosing considerations in RA/PsA

    Dosing and lab monitoring information

    See recommended dosing

    ACR=American College of Rheumatology; BID=twice daily; csDMARD=conventional synthetic disease-modifying antirheumatic drug; IR=inadequate responder; JAK=Janus kinase; JAKi=Janus kinase inhibitor; NS=not significant; PASI=psoriasis area and severity index; PsA=psoriatic arthritis; q 2 wk=every 2 weeks; SC=subcutaneously; TNFi=tumor necrosis factor inhibitor.
    References:
    1. XELJANZ [prescribing information]. New York, NY: Pfizer Inc., October 2020. 
    2. Mease P, Hall S, FitzGerald O, et al. Tofacitinib or adalimumab versus placebo for psoriatic arthritis. N Engl J Med. 2017;377(16):1537-1550. 
    3. Data on file. Pfizer Inc., New York, NY. 
    4. Gladman D, Rigby W, Azevedo VF, et al. Tofacitinib for psoriatic arthritis in patients with an inadequate response to TNF inhibitors. N Engl J Med. 2017;377(16):1525-1536.

    SERIOUS INFECTIONS

    Patients treated with XELJANZ* are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants, such as methotrexate or corticosteroids.

    If a serious infection develops, interrupt XELJANZ until the infection is controlled.

    Reported infections include:

    • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before XELJANZ use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ use.
    • Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.

    The most common serious infections reported with XELJANZ included pneumonia, cellulitis, herpes zoster, urinary tract infection, diverticulitis, and appendicitis. Avoid use of XELJANZ in patients with an active, serious infection, including localized infections, or with chronic or recurrent infection.

    In the UC population, XELJANZ 10 mg twice daily was associated with greater risk of serious infections compared to 5 mg twice daily. Opportunistic herpes zoster infections (including meningoencephalitis, ophthalmologic, and disseminated cutaneous) were seen in patients who were treated with XELJANZ 10 mg twice daily.

    The risks and benefits of treatment with XELJANZ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection, or those who have lived or traveled in areas of endemic TB or mycoses. Viral reactivation including herpes virus and hepatitis B reactivation have been reported. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy.

    Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

    Caution is also recommended in patients with a history of chronic lung disease, or in those who develop interstitial lung disease, as they may be more prone to infection.

    MORTALITY

    Rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular (CV) risk factor treated with XELJANZ 10 mg twice a day had a higher rate of all-cause mortality, including sudden CV death, compared to those treated with XELJANZ 5 mg given twice daily or TNF blockers in a large, ongoing, postmarketing safety study. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. For UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response.

    MALIGNANCIES

    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 other than a successfully treated non-melanoma skin cancer (NMSC) or when considering continuing XELJANZ in patients who develop a malignancy.

    Malignancies (including solid cancers and lymphomas) were observed more often in patients treated with XELJANZ 10 mg twice daily dosing in the UC long-term extension study.

    Other malignancies were observed in clinical studies and the post-marketing setting including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer. NMSCs have been reported in patients treated with XELJANZ. In the UC population, treatment with XELJANZ 10 mg twice daily was associated with greater risk of NMSC. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.

    THROMBOSIS

    Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, have occurred in patients treated with XELJANZ and other Janus kinase inhibitors used to treat inflammatory conditions. RA patients who were 50 years of age and older with at least one CV risk factor treated with XELJANZ 10 mg twice daily compared to XELJANZ 5 mg twice daily or TNF blockers in a large, ongoing postmarketing safety study had an observed increase in incidence of these events. Many of these events were serious and some resulted in death. Avoid XELJANZ in patients at risk. Discontinue XELJANZ and promptly evaluate patients with symptoms of thrombosis. For patients with UC, use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response. XELJANZ 10 mg twice daily or XELJANZ XR 22 mg once daily is not recommended for the treatment of RA or PsA. In a long-term extension study in UC, four cases of pulmonary embolism were reported in patients taking XELJANZ 10 mg twice daily, including one death in a patient with advanced cancer.

    GASTROINTESTINAL PERFORATIONS

    Gastrointestinal perforations have been reported in XELJANZ clinical trials, although the role of JAK inhibition is not known. In these studies, many patients with rheumatoid arthritis were receiving background therapy with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). There was no discernable difference in frequency of gastrointestinal perforation between the placebo and the XELJANZ arms in clinical trials of patients with UC, and many of them were receiving background corticosteroids. XELJANZ should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis or taking NSAIDs).

    HYPERSENSITIVITY

    Angioedema and urticaria that may reflect drug hypersensitivity have been observed in patients receiving XELJANZ and some events were serious. If a serious hypersensitivity reaction occurs, promptly discontinue tofacitinib while evaluating the potential cause or causes of the reaction.

    LABORATORY ABNORMALITIES

    Lymphocyte Abnormalities: Treatment with XELJANZ was associated with initial lymphocytosis at one month of exposure followed by a gradual decrease in mean lymphocyte counts. Avoid initiation of XELJANZ treatment in patients with a count less than 500 cells/mm3. In patients who develop a confirmed absolute lymphocyte count less than 500 cells/mm3, treatment with XELJANZ is not recommended. Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. Monitor lymphocyte counts at baseline and every 3 months thereafter.

    Neutropenia: Treatment with XELJANZ was associated with an increased incidence of neutropenia (less than 2000 cells/mm3) compared to placebo. Avoid initiation of XELJANZ treatment in patients with an ANC less than 1000 cells/mm3. For patients who develop a persistent ANC of 500-1000 cells/mm3, interrupt XELJANZ dosing until ANC is greater than or equal to 1000 cells/mm3. In patients who develop an ANC less than 500 cells/mm3, treatment with XELJANZ is not recommended. Monitor neutrophil counts at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

    Anemia: Avoid initiation of XELJANZ treatment in patients with a hemoglobin level less than 9 g/dL. Treatment with XELJANZ should be interrupted in patients who develop hemoglobin levels less than 8 g/dL or whose hemoglobin level drops greater than 2 g/dL on treatment. Monitor hemoglobin at baseline and after 4-8 weeks of treatment and every 3 months thereafter.

    Liver Enzyme Elevations: Treatment with XELJANZ was associated with an increased incidence of liver enzyme elevation compared to placebo. Most of these abnormalities occurred in studies with background DMARD (primarily methotrexate) therapy. If drug-induced liver injury is suspected, the administration of XELJANZ should be interrupted until this diagnosis has been excluded. Routine monitoring of liver tests and prompt investigation of the causes of liver enzyme elevations is recommended to identify potential cases of drug-induced liver injury.

    Lipid Elevations: Treatment with XELJANZ was associated with dose-dependent increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol. Maximum effects were generally observed within 6 weeks. There were no clinically relevant changes in LDL/HDL cholesterol ratios. Manage patients with hyperlipidemia according to clinical guidelines. Assessment of lipid parameters should be performed approximately 4-8 weeks following initiation of XELJANZ therapy.

    VACCINATIONS

    Avoid use of live vaccines concurrently with XELJANZ. The interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ therapy.

    PATIENTS WITH GASTROINTESTINAL NARROWING

    Caution should be used when administering XELJANZ XR to patients with pre-existing severe gastrointestinal narrowing. There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a non-deformable extended release formulation.

    HEPATIC and RENAL IMPAIRMENT

    Use of XELJANZ in patients with severe hepatic impairment is not recommended.

    For patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 5 mg twice daily, reduce to XELJANZ 5 mg once daily.

    For UC patients with moderate hepatic impairment or with moderate or severe renal impairment taking XELJANZ 10 mg twice daily, reduce to XELJANZ 5 mg twice daily.

    ADVERSE REACTIONS

    The most common serious adverse reactions were serious infections. The most commonly reported adverse reactions during the first 3 months in controlled clinical trials in patients with RA with XELJANZ 5 mg twice daily and placebo, respectively, (occurring in greater than or equal to 2% of patients treated with XELJANZ with or without DMARDs) were upper respiratory tract infection, nasopharyngitis, diarrhea, headache, and hypertension. The safety profile observed in patients with active PsA treated with XELJANZ was consistent with the safety profile observed in RA patients.

    Adverse reactions reported in ≥5% of patients treated with either 5 mg or 10 mg twice daily of XELJANZ and ≥1% greater than reported in patients receiving placebo in either the induction or maintenance clinical trials for UC were: nasopharyngitis, elevated cholesterol levels, headache, upper respiratory tract infection, increased blood creatine phosphokinase, rash, diarrhea, and herpes zoster.

    USE IN PREGNANCY

    Available data with XELJANZ use in pregnant women are insufficient to establish a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and the fetus associated with rheumatoid arthritis and UC in pregnancy. In animal studies, tofacitinib at 6.3 times the maximum recommended dose of 10 mg twice daily demonstrated adverse embryo-fetal findings. The relevance of these findings to women of childbearing potential is uncertain. Consider pregnancy planning and prevention for females of reproductive potential.

    *Unless otherwise stated, “XELJANZ” in the Important Safety Information refers to XELJANZ, XELJANZ XR, and XELJANZ Oral Solution.


    Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

    Rheumatoid Arthritis (RA)

    • XELJANZ®/XELJANZ® XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
    • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    Psoriatic Arthritis (PsA)

    • XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
    • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    Ulcerative Colitis (UC)

    • XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC), who have had an inadequate response or who are intolerant to TNF blockers.
    • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)

    • XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.
    • Limitations of Use: Use of XELJANZ/XELJANZ Oral Solution in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    INDICATIONS AND LIMITATIONS OF USE FOR RA, PsA, UC, AND pcJIA

    Please see full Prescribing Information including BOXED WARNING and Medication Guide.

    Rheumatoid Arthritis (RA): XELJANZ®/XELJANZ® XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

    • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    Psoriatic Arthritis (PsA): XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).

    • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    Ulcerative Colitis (UC): XELJANZ/XELJANZ XR is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response or who are intolerant to TNF blockers.

    • Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.

    Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA): XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older.

    • Limitations of Use: Use of XELJANZ/XELJANZ Oral Solution in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.