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…

Romosozumab Promising for Osteoporosis Treatment; Setbacks for Fulranumab Clinical Trials
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…

OA Knee Pain Treatment Enters Clinical Trials, Ixekizumab Receives FDA Approval & Belimumab Promising for SLE Patients
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…

Biosimilars Debate Heats up over Cost Savings, Safety Concerns
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),…

Rheumatology Drug Updates: Biosimilars Receive Positive News & More
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…
Hidradenitis Suppurativa Can Complicate Biologic Therapy
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,…

Etanercept Submitted to FDA for Approval to Treat Pediatric Plaque Psoriasis; Boehringer Ingelheim & AbbVie to Collaborate; Low Doses of Gerilimzumab Promising for RA
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…

Infliximab Biosimilar Receives FDA Approval
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…
Remicade Antibodies Cross-React to Biosimilars
NEW YORK (Reuters Health)—Patients with antibodies to infliximab in Remicade should not be switched to biosimilars, researchers warn. “(The) antibodies will cross-react with the new biosimilar drug, potentially reducing clinical response,” Dr. Daniel Nagore, director of research and development at Progenika Biopharma in Derio, Spain, told Reuters Health by email. “The study highlights the importance…
FDA Approves Biosimilar to J&J’s Remicade for Multiple Diseases
(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson’s drug Remicade (infliximab), to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Inflectra, also known as infliximab-dyyb, is expected by some analysts to sell for a 25% discount to Remicade, which generated annual…
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