NEW YORK (Reuters Health)—Tofacitinib begun two to three weeks after live zoster vaccination does not impair immunogenicity, and vaccination appears to be safe in patients with pre-existing varicella zoster virus (VZV) immunity, researchers report. Patients with rheumatoid arthritis (RA) are about twice as likely as healthy adults to develop herpes zoster, or shingles, and the… [Read More]
Search results for: Tofacitinib
FDA Committee Recommends Tofacitinib Approval

The FDA Arthritis Advisory Committee voted 10 to 1 to recommend approval of tofacitinib to treat psoriatic arthritis…... [Read More]
Tofacitinib with Methotrexate Not Inferior to Adalimumab with Methotrexate
Highlights from the 2017 EULAR Congress MADRID—Tofacitinib (a JAK inhibitor) used with methotrexate (MTX) is not inferior to adalimumab (a TNF inhibitor) plus MTX in rheumatoid arthritis (RA) patients who’ve had an inadequate response to MTX alone, according to results of a Phase 3B/4 trial presented in a session at the Annual European Congress of… [Read More]
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…. [Read More]
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…... [Read More]
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…... [Read More]
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…... [Read More]
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…... [Read More]
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… [Read More]
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…... [Read More]
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