The FDA is asking for more safety analysis before approving tofacitinib to treat psoriasis. Also, adalimumab and etanercept received the greatest number of adverse and serious adverse events reported to the FDA in 2014…
J&J’s Stelara Succeeds in Phase 3 Crohn’s Disease Trial
(Reuters)—Johnson & Johnson’s Stelara (ustekinumab) was significantly better than placebo at inducing clinical response and remissions in patients with moderate to severe Crohn’s disease, according to data from a late stage trial, providing ammunition for a potential expanded approval of the medicine. Stelara, a biotech medicine that blocks inflammation, is approved to treat plaque psoriasis…
Rituximab May Benefit Patients with Refractory JIA-Associated Uveitis
NEW YORK (Reuters Health)—Rituximab may calm juvenile idiopathic arthritis (JIA)-associated uveitis and especially benefit patients who haven’t responded to other biologic treatments, a study from Italy suggests. With its convenient dosing schedule, rituximab may be a new treatment option for patients with autoimmune diseases, especially for those who have not responded to tumor necrosis factor…
Adalimumab, Tacrolimus Effective for Treating Refractory Ulcerative Colitis
NEW YORK (Reuters Health)—The human IgG1 anti-TNF antibody adalimumab is safe and effective for short- and long-term treatment, and the calcineurin inhibitor tacrolimus given short-term brings remission, in patients with refractory ulcerative colitis, according to two new studies in the Journal of Crohn’s and Colitis. In the first study, online Sept. 21, Dr. Tamas Molnar…
FDA Declines to Expand Approval of Pfizer Arthritis Drug Xeljanz
(Reuters)—U.S. health regulators declined to approve Pfizer Inc’s oral rheumatoid arthritis drug Xeljanz (tofacitinib) to treat moderate to severe cases of plaque psoriasis, the drugmaker said on Wednesday. Pfizer said it received a complete response letter from the Food and Drug Administration. Such letters typically outline concerns and conditions that must be addressed in order…
Phase 3 Trials: Secukinumab for Psoriatic Arthritis & DA-DKP for OA
In a global Phase 3 trial, subcutaneous secukinumab proved safe and effective in patients with psoriatic arthritis. Also, a version of aspartyl-alanyl diketopiperazine, a biologic for knee OA, has entered Phase 3 trials…
Ustekinumab Can Be Used to Safely Treat Teens & More
A recent study showed ustekinumab can be used to treat teens with moderate to severe psoriasis. Also, Phase 2 trials for an analgesic combination drug show it holds promise for reducing post-operative pain…
Novartis Biosimilar Takes Aim at Amgen’s Enbrel
ZURICH (Reuters)—The U.S. Food and Drug Administration has accepted Novartis unit Sandoz’s regulatory submission for approval of a biosimilar copy of Amgen’s blockbuster anti-TNF drug Enbrel, the Swiss drugmaker said on Friday. Enbrel, or etanercept as the drug is known generically, is a big prize since it was the world’s fifth-biggest selling medicine in 2014…
Rituximab for RA Is Safe Long Term, Plus Oxycodone Update
Rituximab was evaluated and found safe as a long-term RA therapy. Also, FDA Advisory Committees voted on oxycodone therapies at a joint meeting.
Methotrexate Halt Feasible in Some Etanercept RA Responders
NEW YORK (Reuters Health)—Certain rheumatoid arthritis (RA) patients doing well on etanercept and methotrexate may be able to quit the latter agent if they have tolerability problems, according to an open-label Canadian study. In a Sept. 11 online paper in Rheumatology, Dr. Boulos Haraoui, of the University of Montreal, and colleagues noted that although combination…
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