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Tofacitinib (new indication: polyarticular juvenile idiopathic arthritis (pJIA), rheumatoid factor positive [RF+] or negative [RF-] polyarthritis and extended oligoarthritis, and juvenile psoriatic arthritis (PsA) in patients aged ≥ 2 years)

Subject:

Active Substance: Tofacitinib
Name: Xeljanz^®
Therapeutic area: Polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
Pharmaceutical company: Pfizer Pharma GmbH

Time table:

Final decision:

a1) Patients with active PJIA for whom previous treatment with disease-modifying antirheumatic drugs (DMARDs) proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib as monotherapy is indicated:
No additional benefit proved
a2) Patients with active PJIA for whom previous treatment with DMARDs proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX)) and treatment with tofacitinib in combination with MTX is indicated:
No additional benefit proved
b1) Patients with active PJIA for whom previous treatment with one or more bDMARDs proved inadequate or was not tolerated and treatment with tofacitinib as monotherapy is indicated:
No additional benefit proved
b2) Patients with active PJIA for whom previous treatment with one or more bDMARDs proved inadequate or was not tolerated and treatment with tofacitinib in combination with MTX is indicated:
No additional benefit proved
c1) Patients with juvenile psoriatic arthritis for whom previous treatment with DMARDs proved inadequate:
No additional benefit proved