From: Evidence Summary
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.
Population |
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Key Inclusion Criteria: Adult outpatients, 19 years of age or older, with an early RA diagnosis, defined as 1 year or less from disease diagnosis Key Exclusion Criteria: Adolescents and adults with RA greater than 1 year from diagnosis |
Drug Therapies Approved by FDA for RA Included in the Review |
Corticosteroid: Methylprednisone, prednisone (PRED), prednisolone (PNL) |
Conventional synthetic DMARD (csDMARD): Hydroxychloroquine (HCQ), leflunomide (LEF), methotrexate (MTX), sulfasalazine (SSZ) |
Tumor necrosis factor (TNF) biologic DMARD: Adalimumab (ADA), certolizumab pegol (CZP), etanercept (ETN), golimumab (GOL), infliximab (IFX) |
Non-TNF biologic DMARD: Abatacept (ABA), rituximab (RIT), sarilumab (SAR),a tocilizumab (TCZ) |
Targeted synthetic DMARD (tsDMARD): Tofacitinib (TOF)a |
Biosimilars: ADA-atto,a IFX-dyyb,a IFX-abda,a ETN-szzsa |
Key Questions Covered by the Review |
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Timing of Review |
Beginning Search Date: January 2011 |
End Search Date: October 5, 2017 |
Overview of Important Studies Underway |
Six trials either ongoing or completed, but findings not yet published.
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New medications that FDA has approved since the prior report
Sharp-van der Heijde method for scoring radiographs
As defined by FDA: Life-threatening, requires hospitalization, leads to lasting disability or congenital anomaly, or jeopardizes the patient in any serious way
Rash, upper respiratory tract infection, nausea, pruritus, headache, diarrhea, dizziness, abdominal pain, bronchitis, leukopenia, injection site reactions
ACR 20/50/70 = American College of Rheumatology 20/50/70% improvement from baseline; AE = adverse event; csDMARD = conventional synthetic disease-modifying antirheumatic drug; DAS = Disease Activity Score; DMARD = disease-modifying antirheumatic drug; ETN = etanercept; FDA = U.S. Food and Drug Administration; HAQ = Health Assessment Questionnaire; MTX = methotrexate; RA = rheumatoid arthritis; SF-36 = Medical Outcomes Study Short Form 36 Health Survey; TCZ = tocilizumab.
From: Evidence Summary
NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.