Psoriatic arthritis (PsA) is remarkably diverse in presentation and course. To assist clinicians in its management, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) published treatment recommendations in 2009 based on a systematic evidence review. To be clinically relevant, such recommendations must be dynamic, and significant developments in PsA pathophysiology and disease assessment, particularly regarding the important contribution of comorbidities coupled with major therapeutic advances, necessitated an update of the GRAPPA recommendations…
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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…
The Microbiome in Pediatric Rheumatic Diseases
The human intestinal microbiota is home to more than 1,000 bacterial species, containing approximately 3 million genes, many of which code for functions that have the potential to affect human physiology.1 Smaller numbers of organisms are also present in the skin, upper gastrointestinal tract, female reproductive tract and the oro- and nasopharynx. As tools have…
Research Provides Insight into Impact of Microbiome on Health, Rheumatic Disease
The microbiome comprises diverse microbial flora, including bacteria, viruses and fungi, that live on mucosal surfaces, predominantly the skin and digestive tract. Microbes evolved billions of years prior to the development of modern Homo sapiens 200,000 years ago; we have always existed with their ubiquitous presence. Despite this, the first microbe was not visualized until…
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…
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…
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…
Rheumatology Drug Updates: Opioid CR845 for OA Pain; RA Treatments in Development
CR845—an oral, peripherally selective kappa opioid agonist—is currently in Phase 2 trials for the treatment of pruritus, and acute and chronic pain.1 Eighty patients with hip osteoarthritis (OA) or knee OA were randomized to receive treatment with 0.25 mg, 0.5 mg, 1.0 mg or 5.0 mg CR845 twice daily for two weeks. Safety assessment, pharmacokinetics…
2015 ACR/ARHP Annual Meeting: Skin Issues in Rheumatic Diseases Present Challenges
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…
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…
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