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…
NEW YORK (Reuters Health)—About two-thirds of patients with ulcerative colitis (UC) had mucosal healing by the end of induction treatment with the infliximab biosimilar CT-P13, according to results of the first prospective study to evaluate this. CT-P13 is the first biosimilar monoclonal antibody of reference infliximab (Remicade) approved in Europe and several other countries where…
NEW YORK (Reuters Health)—The anti-interleukin (IL)-12/IL-23 monoclonal antibody ustekinumab improves signs and symptoms of spondylitis in patients with psoriatic arthritis, according to a post-hoc analysis of data from the PSUMMIT-1 and PSUMMIT-2 trials. “This treatment did seem to have a benefit on axial symptoms,” Dr. Arthur Kavanaugh from the University of California San Diego, La…
Two studies have shown that romosozumab is effective for increasing bone mineral density in both men and women with osteoporosis. And due to safety concerns, Janssen has dropped out of clinical trials for fulranumab, which is being studied to treat OA pain…
Clinical trials have begun to determine if disodium zoledronate tetrahydrate is safe and effective for treating pain in patients with knee osteoarthritis. The FDA has approved the use of ixekizumab for the treatment of plaque psoriasis. And a study has shown that patients with SLE treated with belimumab may be able to decrease steroid use…
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),…
On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 On Jan. 16, 2016, EMA granted marketing authorization in the European Union for Benepali to be used to treat rheumatoid arthritis (RA), psoriatic…
NEW YORK (Reuters Health)—Hidradenitis suppurativa can complicate biologic therapy of chronic inflammatory diseases, according to a retrospective study from France and Belgium. Hidradenitis suppurativa (HS) often responds to treatment with biologic agents, but there have been scattered reports of patients developing HS while undergoing biologic therapy. Dr. Coline Faivre from Hôpital Edouard Herriot in Lyon,…
The FDA has received an application to expand the use of etanercept to treat plaque psoriasis in pediatric patients. Boehringer Ingelheim and AbbVie have announced a collaborative partnership to develop treatments for multiple autoimmune diseases. And gerilimzumab may prove safe and effective for treating inflammatory diseases at very low doses…
The FDA has officially approved an infliximab biosimilar for the treatment of multiple autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Prescribing information is now available…