NEW YORK (Reuters Health)—Pfizer’s expensive arthritis drug tofacitinib has been shown to produce a remission in nearly 1 in 5 patients with moderate to severe ulcerative colitis, but long-term remission persists in fewer than half of those cases. In a series of studies published in the May 4 New England Journal of Medicine, researchers reported…
Tofacitinib Treatment May Improve Nail Psoriasis
NEW YORK (Reuters Health)—The oral Janus kinase (JAK) inhibitor tofacitinib appears to improve moderate to severe nail psoriasis, according to a new study. “Nails are hard to treat in psoriasis and we need better treatments,” says Dr. Luis Garza, a dermatologist at Johns Hopkins School of Medicine in Baltimore, who was not involved in the research….
The OPAL Beyond Study: Tofacitinib Phase 3 Results Positive for Treating PsA
In a recent study, patients with psoriatic arthritis taking tofacitinib had a decrease in disease activity compared with placebo…
Many Patients Discontinue Tofacitinib by Year 1; Fasinumab Promising for Pain
A recent analysis found that about 10% of RA patients taking tofacitinib do not follow recommended guidelines and more than half stop treatment by one year…
Tofacitinib Promising for Psoriatic Arthritis & FDA Issues Alert for Warning for Saxagliptin & Alogliptin Diabetes Treatments
A recent Phase 3 study found tofacitinib safe and effective for treating psoriatic arthritis at both 5 mg and 10 mg doses compared with placebo. And the FDA has added label warnings to saxagliptin and alogliptin for an increased risk of heart failure in individuals taking the drugs, particularly in those with heart and kidney disease…
The ACR Addresses the FDA about the Safe Adoption of Biosimilars in the U.S.; Plus Tofacitinib Approved for RA & Romosozumab May Reduce Fracture Risk
The ACR has continued its advocacy to ensure the safe adoption of biosimilars in the U.S., most recently addressing an FDA public hearing. Also, the FDA has approved tofacitinib for RA, and a clinical trial of romosozumab for patients with osteoporosis met its primary endpoint…
Tofacitinib Shows Ongoing Action Against Plaque Psoriasis
NEW YORK (Reuters Health)—The oral Janus kinase inhibitor tofacitinib (Xeljanz, Pfizer) shows long-term efficacy against chronic plaque psoriasis, according to findings from two randomized studies and an extension trial. The outcome, Dr. Svitlana Tatulych told Reuters Health by email, “demonstrated that oral tofacitinib, at both the 10 mg and 5 mg twice-daily doses, provided sustained…
Tofacitinib Released from FDA REMS Requirement; Plus Biosimilars for Etanercept & Adalimumab Show Promise
Tofacitinib has been released from the FDA’s risk evaluation and mitigation strategy requirement. The FDA is also reviewing a biologics license application for ABP-501, an adalimumab biosimilar. And CHS-0214, a proposed etanercept biosimilar, has met its primary endpoint at Week 24 in an ongoing 52-week study…
Tofacitinib Decreases Inflammation in Early RA
A recent study used MRI to show that tofacitinib reduces inflammation and inhibition of the progression of structural damage in adults with early RA…
Tofacitinib on Hold for Psoriasis, Plus Anti-TNFs Top FDA List for Adverse Events
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…