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  • RA: Efficacy data

    MTX-withdrawal data

    Background DAS28-4(ESR) data from a pivotal trial: ORAL Scan (Study RA-IV) in MTX-IR patients​​​​​​​

    • DAS28-4(ESR) <2.6 response rate for XELJANZ 5 mg BID + MTX at month 6 was 6% (n/N=19/321) vs 1% (n/N=2/160) with placebo (primary endpoint)1
    • The mean DAS28-4(ESR) score for XELJANZ 5 mg BID + MTX (n=237) at month 6 was 4.34 vs 4.81 for placebo (n=49) [secondary endpoint]2
    • The mean change in DAS28-4(ESR) score from baseline for XELJANZ 5 mg BID + MTX (n=237) at month 6 was -2.0 vs -1.6 for placebo (n=49) [secondary endpoint]2

    ORAL Shift is the first MTX-withdrawal study conducted with an approved JAK inhibitor in RA3

    Study design​​​​​​​3

    aDue to protocol deviations, 6 patients who had not achieved CDAI-defined LDA at week 24 (randomization) were included in the double-blind phase and received study treatment (2 in the XELJANZ XR monotherapy group and 4 in the XELJANZ XR + MTX group); these patients were therefore included in the analysis.3

    Study biases

    • Study patients may exhibit greater aggregate efficacy responses in this type of trial design than the same measures from phase 3, double-blind, placebo-controlled trials because randomized withdrawal studies are enriched with responders4
    • The run-in phase was open label; all subjects knew they were taking XELJANZ XR 11 mg QD + MTX3
    • Since this was a withdrawal design, primary efficacy endpoint was analyzed for only those patients achieving LDA at the randomization visit3
    • Study patients who cannot tolerate the test drug are likely to discontinue at or before the randomization visit and may not have been included in the DB phase safety analysis4

    Study limitations

    • Use of a different outcome measure for the randomization decision than what was used for the primary endpoint (CDAI vs DAS28-4[ESR])3
    • Due to withdrawal design, there was no placebo control group during the run-in phase3
    • Immediate withdrawal of MTX following randomization to the XELJANZ XR 11 mg QD monotherapy arm, whereas current guidelines recommend cautious tapering of RA treatment to avoid risk of flares3,5

    Open-label phase patient disposition3​​​​​​​

            23%
           (n/N=161/694)
    Of patients discontinued by week 24a
                       23%
                      (n/N=161/694)
    Of patients discontinued by week 24a
    • The majority of discontinuations were either due to insufficient clinical response (n=91) or due to an AE (n=42)3
    • The remaining 533 patients completed the open-label phase, achieved CDAI ≤10, and were randomized to the double-blind phase3,a,b
    a533 patients met CDAI ≤10; 3 patients were randomized but did not receive treatment in double-blind phase.3
    bDue to protocol deviations, 6 patients who had not achieved CDAI-defined LDA at week 24 (randomization) were included in the double-blind phase and received study treatment (2 in the XELJANZ XR monotherapy group and 4 in the XELJANZ XR + MTX group); these patients were therefore included in the analysis.3

    In ORAL Shift, XELJANZ XR after MTX withdrawal was noninferior to XELJANZ XR + MTX in patients who achieved CDAI-defined low disease activity2,3,6,a,b

    ORAL Shift in MTX-IR patients

    aDue to protocol deviations, 6 patients who had not achieved CDAI-defined LDA at week 24 (randomization) were included in the double-blind phase and received study treatment (2 in the XELJANZ XR monotherapy group and 4 in the XELJANZ XR + MTX group); these patients were therefore included in the analysis.3
    bLDA defined as CDAI ≤10.3​​​​​​​
    • Discontinuation rates during the double-blind phase: a total of 45 patients discontinued3
      • In the XELJANZ XR arm, 26 patients discontinued. Reasons for discontinuation included AEs (n=6), insufficient clinical response (n=6), withdrawal from study (n=5), protocol violations (n=5), lost to follow-up (n=1), screen failure (n=1), or other reasons (n=2)
      • In the XELJANZ XR + MTX arm, 19 patients discontinued. Reasons for discontinuation included AEs (n=6), withdrawal from study (n=2), protocol violations (n=2), death (n=2), insufficient clinical response (n=1), lost to follow-up (n=1), or other reasons (n=5)

    DAS28-4(ESR) response rates with XELJANZ XR + MTX and after MTX withdrawal in patients who achieved CDAI-defined low disease activity2,3,a,b,c

    These DAS28-4(ESR) response rates should not be compared with those of other trials since ORAL Shift represents a population that had already achieved LDA. Data shown represent patients in the DB cohort (achieved CDAI-defined LDA at week 24 and were randomized and received treatment during the DB phase).3

    aA DAS28-4(ESR) score of ≤3.2 indicates that the patient has low disease activity.3
    bLDA defined as CDAI ≤10.3
    cNonresponder imputation was applied to missing data.3​​​​​​​

    Differences in ACR response rates during the double-blind phase in patients who achieved low disease activity (CDAI ≤10) at week 242,3,a

    aThe full analysis set of the DB cohort was analyzed and nonresponder imputation was applied to missing data (FAS-DB, NRI).2,3
    • Randomized withdrawal studies are enriched with responders, so absolute efficacy rates are higher than those seen in phase 3 studies. Therefore, these ACR response rates should not be compared with those of other trials4

    Safety data from the double-blind phase

    • Study patients who cannot tolerate the test drug are likely to discontinue at or before the randomization visit and may not have been included in the DB phase safety analysis4
    • Most common AEs3:
      • Arthralgia, bronchitis, LFT elevations, nasopharyngitis, and upper respiratory tract infection
      • In the XELJANZ XR arm, there were 10 SAEs and 5 discontinuations due to AEs. In the XELJANZ XR + MTX arm, there were 5 SAEs and 5 discontinuations due to AEs
    • Selected AEs of special interest3
      • In the XELJANZ XR arm: serious infections (1%, n=2), herpes zostera (1%, n=2), malignanciesb (excluding NMSC) [<1%, n=1], and NMSCb (<1%, n=1)
      • In the XELJANZ XR + MTX arm: serious infections (1%, n=2), herpes zostera (1%, n=3), NMSCb (<1%, n=1), and MACEb,c (<1%, n=1)
    aAll herpes zoster events reported involved 1 or 2 adjacent dermatomes and were nonserious.3
    b
    Reviewed by an independent adjudication committee.3
    cOccurred more than 28 days after the last dose of study treatment in the double-blind phase.3

    RA clinical trials

    • Most common adverse reactions from RA clinical trials in the first 3 months of placebo-controlled XELJANZ studies included (percent of patients)1,a:
      • In the XELJANZ 5 mg BID arm (n=1336): Upper respiratory tract infection (4%), nasopharyngitis (4%), diarrhea (4%), headache (4%), and hypertension (2%)
      • In the placebo arm (n=809): Upper respiratory tract infection (3%), nasopharyngitis (3%), diarrhea (2%), headache (2%), and hypertension (1%)
    aOccurring in ≥2% of patients on XELJANZ 5 mg BID with or without DMARDs (0-3 months) and ≥1% greater than that observed in patients on placebo.1

    A 48-week, randomized, double-blind (after run-in phase), phase 4 withdrawal trial in 694 patients with moderately to severely active RA. At screening, subjects were required to have had an inadequate response to MTX; potential subjects with prior exposure to XELJANZ, baricitinib, or other JAK inhibitors were excluded. In the open-label, 24-week run-in phase, all patients received XELJANZ XR 11 mg QD + weekly MTX. At week 24, patients achieving CDAI-defined low-disease activity (CDAI ≤10) were randomized to the 24-week DB phase to receive XELJANZ XR + continued MTX or XELJANZ XR monotherapy following immediate MTX withdrawal. CDAI was chosen to determine eligibility for continuation into DB phase (can be calculated on same day as study visit). Randomization was stratified by prior exposure to bDMARDs. 76% of patients (n=530) attained CDAI-defined LDA and were randomized and treated in the double-blind phase. Stable low-dose glucocorticoids allowed; bDMARDs and other csDMARDs prohibited. The primary endpoint was the difference in ΔDAS28-4(ESR) score from week 24 (randomization) to week 48 (end of DB phase), powered to test noninferiority of XELJANZ XR monotherapy following MTX withdrawal to XELJANZ XR + continued MTX. NI is demonstrated if the upper bound of the 95% two-sided confidence interval around the difference in ΔDAS28-4(ESR) is lower than 0.6. Nonresponder imputation for patient withdrawal and last observation carried forward for patients with missing data before withdrawal were used to handle missing data for binary endpoints.1,2

    bDMARD=biologic disease-modifying antirheumatic drug; CDAI=Clinical Disease Activity Index; csDMARD=conventional synthetic disease-modifying antirheumatic drug (also known as a nonbiologic DMARD); DAS28-4(ESR) =Disease Activity Score for 28-joint counts based on erythrocyte sedimentation rate; DB=double-blind; JAK=Janus kinase; JAKi=Janus kinase inhibitor; LDA=low disease activity; MTX=methotrexate; NI=noninferiority; QD=once daily; RA=rheumatoid arthritis; XR=extended release.
    References:
    1. ​​​​​​​Cohen SB, Pope J, Haraoui B, et al. Methotrexate withdrawal in patients with rheumatoid arthritis who achieve low disease activity with tofacitinib modified-release 11 mg once daily plus methotrexate (ORAL Shift): a randomised, phase 3b/4, non-inferiority trial. Lancet Rheumatol. Published online August 6, 2019. doi:10.1016/S2665-9913(19)30005-0
    2. Data on file. Pfizer Inc., New York, NY.

    ORAL Shift MTX-withdrawal study design

    ORAL Shift publication

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    RA safety data

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    Dosing considerations in RA/PsA

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    See JAKi market experience for XELJANZ—#1 most prescribed JAK inhibitor for moderate to severe RA.1,2,a

    aInternal calculations by Pfizer based on IQVIA database of new prescription (NRx) and total prescription (TRx) JAK inhibitors prescribed for RA, monthly as of December 2020.2

    ACR=American College of Rheumatology; AE=adverse event; BID=twice daily; CDAI=Clinical Disease Activity Index; CI=confidence interval; DAS28-4(ESR)=Disease Activity Score for 28-joint counts based on erythrocyte sedimentation rate; DB=double-blind; DMARD=disease-modifying antirheumatic drug; FAS=full analysis set; IR=inadequate responder; JAK=Janus kinase; JAKi=Janus kinase inhibitor; LDA=low disease activity; LFT=liver function test; LSM=least squares mean; MACE=major adverse cardiovascular event; MMRM=linear mixed-effect model of repeated measures; MOA=mechanism of action; mTSS=modified Total Sharp Score; MTX=methotrexate; NI=noninferiority; NMSC=nonmelanoma skin cancer; NRI=nonresponder imputation; PsA=psoriatic arthritis; QD=once daily; RA=rheumatoid arthritis; XR=extended release.

    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.