This will be efficacy and safety of Induction and Tapering Therapy with Tofacitinib and Glucocorticoid in patients with Polymyalgia Rheumatica (ITTG PMR): An open-label 52-week randomized controlled trial
PMR patients who fulfilled the 1982 Chuang criteria or 2012ACR/EULAR criteria for PMR; They did not receive any glucocorticoids or biological agents during the 2 weeks period that preceded their inclusion in the study;
Patients with high activity rheumatic polymyalgia: disease activity score PMR-AS (Table 3) > 10,
Adults age 50-88, Weight 45-85Kg,
ESR>20mm/h or CRP >50mg/L (5mg/dl),
Patients with known allergies to tofacitinib, prednisone or methylprednisolone,
Patients with identified giant cell arteritis, systemic lupus erythematosus, rheumatoid arthritis, calcium pyrophosphate deposition (CPPD) arthropathy, and other rheumatic diseases,
Patients with severe osteoarthritis,
Subjects with any severe acute, chronic or recurrent infection (e.g. pneumonia or pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.),
Parallel
Prednisone+Tofacitinib
DrugWithdrawal of prednisone (or equivalent dose of methylprednisolone) within 4 weeks: 5mg tid for 2 weeks, 5mg bid for 1 week, 5mg qd for 1 week, then discontinue. Take Tofacitinib 10mg/d for 3 months, then 7.5mg/d for 2 months, followed by 5mg qd for 2 months, then 5mg qod for 2 months, and finally 5mg every 3 days for 2 months, discontinue the Tofacitinib for 1 month. If there is a relapse during the dose reduction process, resume Tofacitinib at the original dosage.
Prednisone
DrugPrednisone 15mg (or equivalent dose of methylprednisolone) was set as the initial treatment of PMR. When improvement was achieved, the dose of Prednisone was reduced to 10mg daily within 4-10 weeks; When remission was achieved, then taper Prednisone gradually by 2.5mg every 6-8 weeks. Once relapse occurred, the dose increased to the pre-relapse dose. If reducing pred dosage is difficult, Methotrexate (MTX) 10mg qw can be added after 24 weeks.
Proportion of patients with PMR-AS score <10 score at weeks 52
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+\[morning stiffness (min) x0.1\]+ EUL (0-3)
PMR-AS score at weeks 24
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+\[morning stiffness (min) x0.1\]+ ability to elevate the upper limbs(EUL 0-3)
PMR-AS score at weeks 52
PMR-AS score: CRP (mg/dL)+Patient self-evaluation (0-10 visual scale)+ Physician global assessment (0-10 Visual Scale)+\[morning stiffness (min) x0.1\]+EUL (0-3)
CRP at weeks 24
CRP (mg/dL)
CRP at weeks 52
CRP (mg/dL)
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