(Reuters)—Valeant Pharmaceuticals International Inc.’s experimental drug to treat psoriasis carries a potential risk of suicide that is challenging to assess due to limited data, a preliminary review by the U.S. Food and Drug Administration said on Friday. The review comes two days ahead of a meeting of outside experts who will advise the FDA on…
Patients with PsA, Cutaneous Psoriasis May Undergo Hip Replacement
A recent study of patients with psoriatic arthritis and cutaneous psoriasis found that these patients do not have a higher risk of worse outcomes after total hip arthroplasty compared with patients with osteoarthritis…
Biosimilars Update: FDA Panel Voted to Approve Biosimilars for Etanercept & Adalimumab at July Meeting
In July, the FDA’s Arthritis Advisory Committee will meet and review proposed biosimilars for etanercept and adalimumab to treat multiple rheumatic diseases…
FDA Panel Supports Novartis Biosimilar of Etanercept
(Reuters)—Novartis AG’s cheaper version of Amgen Inc.’s arthritis drug etanercept (Enbrel) is highly similar in potency and safety to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The panel voted 20–0 that there is no clinically meaningful difference between Novartis’s drug, a biologic made…
Ethics Forum: Unexpected Ethical Issues in Private Practice, Clinical Research
Ethical issues that arise in the average rheumatology practice and in clinical research are often straightforward. The AMA Code of Medical Ethics and the Office Practice and Procedures Manual offer useful information.1 In research, the Protocol and Investigators Agreement spells out who you can enroll and how the trial must be conducted. But still—even when…
Rheumatology Coding Corner Answer: Physical Examination with Infliximab Infusion
Take the challenge. CPT: 99214-25, 96413, 96415 x 1, J1745 x 35 ICD-10: M07.68, K51.80 Billing Overview It is appropriate to bill for an E/M visit for this day of service along with the infusion procedure. Modifier 25 should be appended to the E/M, indicating that the patient received a significant, separately identifiable E/M service…
Rheumatology Coding Corner Question: Physical Examination with Infliximab Infusion
A 12-year-old male established patient with inflammatory bowel disease with associated juvenile spondyloarthropathy returns to the office for a follow-up visit for his infliximab infusion. The patient reports moderate pain in his right hip after walking for extended periods of time or after sports activities. He denies any other joint pain and denies any joint…
How HLA-B27 Research Landmarks, Advances Relate to Ankylosing Spondylitis Pathogenesis
The mechanistic link between human leukocyte antigen B27 (HLA-B27) and ankylosing spondylitis (AS) is one of the great enigmas in rheumatology. The introduction of biological therapies that target tumor necrosis factor (TNF) or the interleukin (IL) 23/IL-17A axis has had a major impact on the quality of life for many patients with AS, and one…
FDA Panel Backs Amgen Biosimilar of Humira
(Reuters)—Amgen Inc.’s cheaper version of AbbVie’s top-selling arthritis drug adalimumab (Humira) is highly similar to the original and should be approved, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted 26–0 that the drug, ABP 501, which was studied in rheumatoid arthritis and plaque psoriasis, was similar in…
Exercise Therapy Recommended to Manage Knee Osteoarthritis
The benefits of exercise therapy for individuals with knee osteoarthritis (OA) are well known. The ACR strongly recommends both aquatic exercise and land-based aerobic and resistance exercise for managing knee OA.1 A recent Cochrane systematic review and meta-analysis concluded that high-quality evidence supports the use of exercise to reduce pain and improve physical function and…
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