NEW YORK (Reuters Health) – The anti-inflammatory drug adalimumab can provide significant relief for about a quarter of people who suffer from a moderate-to-severe case of the chronic skin condition hidradenitis suppurativa, according to two 36-week trials. But the drug – which would cost over $104,000 per year for the weekly injections used in the…
Generic TNF-Alpha Inhibitors Comparable to Established Brands
NEW YORK (Reuters Health)—Biosimilar tumor necrosis factor-alpha inhibitors appear equivalent to the branded original versions, according to a systematic review and meta-analysis. As Dr. G. Caleb Alexander tells Reuters Health by email, “biologic treatments represent a rapidly growing proportion of prescription drug expenditures and thus there is enormous interest in whether or not biosimilar products…
New RA Therapy Promising in Clinical Trial
Results from a clinical trial support the efficacy of vobarilizumab for treating RA. Plus, the UK will recommend the use of certolizumab pegol to treat severe cases of RA in upcoming guidelines…
Methotrexate with Step-Down Glucocorticoid Remission Induction Works in Early RA
NEW YORK (Reuters Health)—Methotrexate with step-down glucocorticoid remission induction (COBRA Slim) is an effective, safe and feasible initial treatment strategy for patients with early rheumatoid arthritis (RA), researchers from Belgium report. Patients with early RA should be treated rapidly, intensively and to target, according to current guidelines, they note in a paper online July 18…
Secukinumab Inhibits Structural Joint Damage in Active PsA
Psoriatic arthritis (PsA), a chronic inflammatory arthritis characterized by structural damage to the joints, has been associated with reduced health-related quality of life, disability and reduced life expectancy. The joint changes in PsA are characterized radiographically by a combination of erosive and proliferative bone changes, including erosive joint destruction, fluffy periostitis and pencil-in-cup deformities. Radiographic…
EMA Flags Faulty Generic Drug Data, Backs Sales Halt
(Reuters)—The European Medicines Agency (EMA) recommended suspending sales of some generic drugs after a review found that data collected by a contract research company in India for their approval was unreliable. The EMA’s list included drugs made by some of the top generic drugmakers, including Teva Pharmaceutical Industries Ltd., Mylan NV and Novartis AG’s Sandoz….
Underprescribing Adds to Mortality, Hospitalization for Oldest Patients
NEW YORK (Reuters Health)—Inappropriate underprescribing of medications is associated with increased mortality and hospitalization rates among community-dwelling adults aged 80 years and older, researchers from Belgium report. “Patients with five or more medications (a standard cut-off used for polypharmacy) can have a well-tailored and balanced medication therapy with an acceptable risk for adverse events,” Dr….
U.S. FDA Panel Backs Valeant Psoriasis Drug with Risk Program
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis should be approved as long as certain measures are put in place to mitigate the risk of suicide, an advisory committee to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically…
Tildrakizumab Promising for Plaque Psoriasis; FDA Approves Adalimumab to Treat Panuveitis
n clinical trials, tildrakizumab was more effective than etanercept and placebo at treating moderate to severe plaque psoriasis. Adalimumab has received approval for treating non-infectious intermediate, posterior and panuveitis—its 10th FDA indication…
Valeant Psoriasis Drug’s Suicide Risk Hard to Assess, Say FDA Staff
(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday. The review comes two days ahead of a meeting of outside experts who will advise the FDA on…
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