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…
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
Secukinumab, an anti-interleukin-17A monoclonal antibody, has successfully completed multiple clinical trials, which found the intravenous treatment may be safe and effective for treating patients with active ankylosing spondylitis…
New research indicates that vaccination for the herpes zoster virus in patients with rheumatoid arthritis starting tofacitinib appears to be both safe and useful. Rheumatologists may want to check the patient’s pre-existing immunity status prior to administering the vaccine…
SAN FRANCISCO—A 40-year-old woman shows up in the clinic with scarring alopecia, with an area of hyperpigmentation on the rim of her scalp, extending from just behind the temple to behind her ears. An examination with a dermatoscope shows hyperkeratotic follicular plugging. The case—in this example, the discoid form of cutaneous lupus erythematosus (DLE)—is one…
One of your first clinical assignments as a medical student was likely to have been the lung exam. Its key descriptors may still resonate in your mind: inspection, palpation, percussion and auscultation. Proudly parading down the hospital corridors, your newly purchased stethoscope snugly tucked inside your lab coat pocket, you carefully place its cold metal…
The Case A 41-year-old woman was referred to the dermatology clinic for a three-month history of tender lesions on her elbows and around the joints of her hands. Her medical history was notable for seropositive, non-erosive rheumatoid arthritis (RA), which was being treated with 5 mg prednisone daily, 10 mg methotrexate weekly by mouth, 200…
A recent study used MRI to show that tofacitinib reduces inflammation and inhibition of the progression of structural damage in adults with early RA…
An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
Three clinical trials are evaluating subcutaneous sirukumab for safety and efficacy in treating rheumatoid arthritis. And a study found no significant difference in persistence and remission for TNF-α monotherapy when compared with TNF-α plus conventional DMARD combination therapy for treating psoriatic arthritis…