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Articles tagged with "Safety"

Brodalumab Approved for Plaque Psoriasis, Plus Baricitinib Effiicacy Studied for RA

Michele B. Kaufman, PharmD, BCGP  |  April 20, 2017

Brodalumab Approved for Plaque Psoriasis The U.S. Food and Drug Administration has approved brodalumab, a monoclonal antibody that targets interleukin 17 (IL‑17).1,2 Brodalumab (Siliq) was approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond to, or have lost response to, other…

Biosimilar Drugs Raise Questions around Treatment Efficacy, Quality, Safety

Thomas R. Collins  |  April 20, 2017

WASHINGTON, D.C.—Challenges abound for the manufacturing of biosimilar drugs—from their sheer size compared with small molecule drugs to the unknowable proprietary aspects of the originator drugs—an expert said at the 2016 ACR/ARHP Annual Meeting in a session titled Immunology Update: Biologic Agents: From Nature to Protein Engineering to Biosimilars. Above all, because biosimilars are copies…

FDA Drug Labeling, Approval Process Help Minimize Lawsuits Against Pharmaceutical Companies

Bruce N. Cronstein, MD  |  April 17, 2017

Like many people, I am up early and in the gym most days. Although I don’t seem to get anywhere new on the stationary bicycle or the elliptical machine, I do get to keep up with the pundits on the early morning talk shows. In contrast to the television series I binge on later in…

Rheumatology Practices Need Sharp Focus on Patient Care Safety, Quality

Carina Stanton  |  February 16, 2017

“It is not necessary to change. Survival is not mandatory.” —W. Edwards Deming For practices to survive, change is a requirement—not an option—in the rapidly evolving practice of rheumatology care. Pharmaceutical therapies are advancing quickly, opening the door for game-changing therapies in the treatment of chronic autoimmune disorders. With these advances comes a need for…

Rheumatology Drug Updates: Efficacy & Safety of Guselkumab, Plus FX006 for Knee OA

Kelly April Tyrrell  |  February 16, 2017

Guselkumab Improves Active Psoriatic Arthritis New research has revealed that patients with active psoriatic arthritis (PsA) and ≥3% body area of plaque psoriasis benefit from treatment with a human monoclonal antibody known as guselkumab (GUS). GUS is specific for the p19 subunit of interleukin 23 (IL-23). Patients in the Phase 2 clinical trial experienced significant…

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Tips, Resources to Help Rheumatologists Educate Patients on Biologics and Biosimilars

Vanessa Caceres  |  February 15, 2017

Rheumatologists are accustomed to educating patients about medications—but biologic medications require some additional time and discussion. “Biologics are inherently more complex [than other medications], and there are multiple issues to consider before initiating treatment,” says K. “Kwas” Huston, MD, The Center for Rheumatic Disease, Kansas City, Mo. “This includes the patient’s disease activity, prior medications…

Rheumatology Drug Updates: Giant Cell Arteritis Relapse Possible if Tocilizumab Discontinued; Plus Updates on Rituximab, Etanercept

Michele B. Kaufman, PharmD, BCGP  |  January 19, 2017

GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…

Electronic Medical Records Have Mixed Impact on Quality, Quantity of Healthcare

David S. Knapp, MD, FACR  |  January 17, 2017

The widespread implementation of electronic medical records (EMRs) and electronic health records (EHRs) has significantly changed the quality and quantity of healthcare for both the better and the worse. The digitalization of medical records provides comprehensive documentation of all events and actions associated with an individual’s medical care. Likewise, legibility, accountability and credibility are greatly…

Rheumatology Drug Updates: Celecoxib and Cardiovascular Safety Trial Results Reviewed

Michele B. Kaufman, PharmD, BCGP  |  December 13, 2016

Nonsteroidal anti-inflammatory drugs (NSAIDs) have been used therapeutically since the 1960s.1 Evidence of adverse cardiovascular outcomes led to the withdrawal of the selective COX-2 inhibitor rofecoxib in September 2004, when the question of cardiovascular safety of NSAIDs first came into the limelight.2 Valdecoxib (Bextra) was subsequently withdrawn from the market in April 2005 due to…

Rheumatology Drug Updates: Abaloparatide Promising for Osteoporosis, Plus Secukinumab for Ankylosing Spondylitis

Michele B. Kaufman, PharmD, BCGP  |  October 10, 2016

Abaloparatide for Osteoporosis Abaloparatide is completing Phase III clinical trials for the potential treatment of postmenopausal osteoporosis in women who are at an increased risk of fracture.1 Abaloparatide is a synthetic peptide that engages the parathyroid hormone receptor and has favorable bone building activity. Abaloparatide has completed Phase 3 development for use as a daily…

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