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…
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…
Opana ER Pulled from U.S. Market Last month, the U.S. Food and Drug Administration (FDA) asked Endo Pharmaceuticals to remove oxymorphone hydrochloride extended release (Opana ER) from the U.S. market due to public health consequences related to abuse. The agency has concerns that the risks presented by the treatment do not outweigh its benefits.1 On…
Soon, rheumatologists may have another drug to offer their patients with refractory rheumatoid arthritis (RRA) for whom effective and safe treatment remains challenging. A study published in the New England Journal of Medicine shows that patients with RRA treated with once-daily baricitinib in a 4 mg dose had a significant clinical improvement in symptoms of…
GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…
Ixekizumab Improves Work Productivity in Patients with Plaque Psoriasis Indirect costs of reduced work productivity can have a significant impact on a patient’s quality of life. A recent article published in JAMA Dermatology analyzed the results of three multicenter, randomized double-blind Phase 3 trials, UNCOVER-1, UNCOVER-2 and UNCOVER-3, which evaluated the effect of ixekizumab on…
CR845—an oral, peripherally selective kappa opioid agonist—is currently in Phase 2 trials for the treatment of pruritus, and acute and chronic pain.1 Eighty patients with hip osteoarthritis (OA) or knee OA were randomized to receive treatment with 0.25 mg, 0.5 mg, 1.0 mg or 5.0 mg CR845 twice daily for two weeks. Safety assessment, pharmacokinetics…
The field of rheumatology took center stage when a handful of speakers discussed trends and research during a disease-oriented session of the 2015 Federation of Clinical Immunity Societies (FOCIS 2015) conference held in San Diego in June. Neutrophils in SLE Mariana Kaplan, MD, chief of Systemic Autoimmunity Branch at the National Institute of Arthritis and…
A presentation given during FOCIS 2015, the 15th annual meeting of the Federation of Clinical Immunity Societies in June 2015 in San Diego, focused on advances in stem cell research related to treatment of cancer and the function that particular enzymes play in disease. Anjana Rao, PhD, professor at the La Jolla Institute for Allergy…
ROME, Italy—The traditional approach to trials to assess new biomarkers and related treatments has largely been inefficient, and a better strategy is needed to make stratified treatment available for patients more quickly, an expert said at EULAR 2015, the annual congress of the European League Against Rheumatism (EULAR). Mahesh Parmar, PhD, director of the Medical…