How are COVID-19 and physical distancing restrictions at work affecting rheumatology professionals? The Rheumatologist interviewed clinical pharmacist Wendy Ramey, BSPharm, RPh, CSP, to discuss how the pandemic has changed the way her staff supports rheumatologists at the University of Kentucky Specialty Pharmacy and Infusion Services, Lexington. Ms. Ramey describes how these unprecedented times affect patients,…
Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
While medical advances in rheumatoid arthritis (RA) have led to improvements in disease control and quality of life for patients worldwide, the rate for stable remission remains low.1 Management of RA symptoms is traditionally accomplished through a combination of medications and nonpharmacological interventions.2 This approach can prevent the development of secondary adverse health outcomes. Two…
Research has shown that anticonvulsants are teratogens and pose a risk for fetal malformations. Meadow was the first to note a possible link between congenital abnormalities and maternal use of anticonvulsive drug in 1968.1 In 1974, Barr et al noted hypoplasia and irregular ossification of the digital distal phalanges with nail dystrophy in children born to…
As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…
MADRID—Scores on the Health Assessment Questionnaire for Rheumatoid Arthritis (HAQ) and C-reactive protein (CRP) levels were independent predictors of whether patients could be tapered successfully from a TNF inhibitor after having reached remission of their RA, according to findings presented in a session at the Annual European Congress of Rheumatology. Researchers also developed a composite…
MADRID—The anti-IL6 “nanobody,” vobarilizumab, produced mixed results when used with methotrexate (MTX) and compared with MTX and placebo, according to results of a 24-week, double-blind Phase 2b study of patients with rheumatoid arthritis (RA), which were presented in an abstract session at the Annual European Congress of Rheumatology (EULAR). The drug missed its primary endpoint…
MADRID—Tofacitinib (a JAK inhibitor) used with methotrexate (MTX) is not inferior to adalimumab (a TNF inhibitor) in rheumatoid arthritis (RA) patients who’ve had an inadequate response to MTX alone, according to results of a Phase 3B/4 trial presented in a session at the Annual European Congress of Rheumatology (EULAR). The findings came in a one-year…
Abatacept Approved for Adult PsA On June 30, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) to treat adults with active psoriatic arthritis (PsA).1 Abatacept is available as both an intravenous formulation and a subcutaneous injection.2 The approval was based on results of two randomized, double-blind, placebo-controlled trials, PsA-I and PsA-II, during which…
Patients with a diagnosis of rheumatoid arthritis (RA) experience on average double the risk of developing malignant lymphoma when compared with the general population. With the major changes in RA treatment taking place over the past decade, has there been a reduction in the risk of lymphoma in this population? Researchers from the Karolinska Institute…