At a recent symposium, Kristin Highland, MD, reported on the use of antirheumatic treatments, specifically methotrexate, and their connections with pulmonary toxicity in patients.
Public Rarely Knows Why FDA Rejects New Drugs
(Reuters Health)—Drug companies generally don’t disclose all the reasons new medicines fail to win U.S. marketing approval, even though regulators often reject treatments over concerns about safety or effectiveness, a study finds. Researchers compared the details companies made public in press releases with confidential documents from the U.S. Food and Drug Administration known as complete…
Biosimilars for RA Studied in Multiple Trials
Biosimilars for etanercept and sarilumab are being examined in multiple Phase 3 trials for their effects in RA and psoriasis patients.
Increased Risk of Serious Infections During Early Anti-TNF Treatment
NEW YORK (Reuters Health)—The risk of serious infections increases in the early months of anti-TNF treatment for inflammatory bowel disease, researchers from Denmark report. “The pro-inflammatory cytokine TNF-alpha plays an important role in the immune system and therefore it is biologically plausible that TNF-alpha inhibitors may increase the risk of infections,” said Dr. Nynne Nyboe…
Ixekizumab Clinical Trials Continue; FDA Updates Warning Label for Varenicline
It seems to have begun in Norway, the international pressure to switch patients from well-known brand biologic agents, such as Remicade (infliximab), to biosimilar agents, due to a significant cost advantage.1 This biosimilar came with a 39% price markdown last year compared with the brand, and when Norway called for bids, the discount went to…
Glucocorticoid Use for Rheumatoid Arthritis Still Sparks Debate
Glucocorticoids: The Debate Continues Déjà vu … In past decades, rheumatologists have seen, heard, practiced and taught much of what has been argued in the “ongoing debate” on the use of glucocorticoids (GCs) in the management of rheumatoid arthritis (RA).1 It is heartening to note that eminent professors have stuck to their premise all these…
Tofacitinib Effective for Treating Moderate-to-Severe Chronic Plaque Psoriasis
NEW YORK (Reuters Health)—Tofacitinib is better than placebo (and noninferior to etanercept) for treating patients with moderate-to-severe chronic plaque psoriasis, according to Pfizer’s OPT Compare trial. In an earlier 12-week, phase 2b, dose-ranging trial, the oral JAK inhibitor tofacitinib proved to be more effective than placebo for treating patients with moderate-to-severe plaque psoriasis. Based on…
Data Collection Drives Evaluation of Psoriasis Treatments
For six years, the Psoriasis Longitudinal Assessment and Registry (PSOLAR) has collected data to assess the infection risk for drugs treating systemic psoriasis.
U.S. NIH Drug Facility Suspended after Contamination Found
(Reuters)—The National Institutes of Health said on Thursday it had suspended operations of a facility that makes products used for clinical research after the discovery of fungal contamination in two vials of albumin. Vials made from the same batch of albumin had been administered to six patients, though it is not known if those were…
Biologic Drugs for Psoriasis Are Rarely Stopped for AEs
NEW YORK (Reuters Health)—Real-world psoriasis patients receiving biologic therapies rarely stop taking the drugs because of adverse effects, researchers say. Although data from long-term registries have shown similar results, “the demographics of patients in registries are somewhat different than those of patients in real-world practices,” Dr. Jensen Yeung told Reuters Health by email. “I have…
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