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Biologics/DMARDs

Guselkumab Improves Active Psoriatic Arthritis

Michele B. Kaufman, PharmD, BCGP, & Lara C. Pullen, PhD  |  January 11, 2017

A study showed that guselkumab may decrease symptoms of psoriatic arthritis and improve quality of life in adult patients…

New Test Yields Rapid Infliximab Drug Concentrations

Will Boggs, MD  |  December 22, 2016

NEW YORK (Reuters Health)—A new test provides rapid infliximab drug concentrations that enable immediate dosing adjustments, researchers from Belgium report. “With this rapid test, our biggest wish is to persuade physicians to now perform and use infliximab measurements also in their own daily clinical practice, as many practical and organizational issues that went along with…

GCA Relapse Possible When Discontinuing Tocilizumab

Michele B. Kaufman, PharmD, BCGP  |  December 14, 2016

A recent study found that although patients with giant cell arteritis respond positively to long-term tocilizumab treatment, relapse may occur after discontinuing the medication…

U.S. Supreme Court Declines to Hear Biologic Drug Patent Fight

Brendan Pierson  |  December 12, 2016

WASHINGTON (Reuters)—The U.S. Supreme Court on Monday declined to hear a case over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval before bringing them to the market. The justices opted not to take up Apotex Inc.’s appeal of a July federal appeals court ruling that could…

FDA Update on Rituximab & Etanercept; Plus New ACP Gout Guideline

Michele B. Kaufman, PharmD, BCGP  |  November 30, 2016

The FDA is considering an application for subcutaneous rituximab and has approved an application for etanercept to treat pediatric patients with plaque psoriasis…

Reinitiating TNF Blockers after Tuberculosis Treatment

Michele B. Kaufman, PharmD, BCGP  |  November 23, 2016

A retrospective study showed that patients who have rheumatic disease and develop tuberculosis may be able to resume anti-TNF therapy and other biologic agents…

TNF Inhibitor Tied to Lower Cardiovascular Risk in Psoriasis

Lorraine L. Janeczko  |  November 22, 2016

NEW YORK (Reuters Health)—Psoriasis patients treated with tumor necrosis factor-alpha (TNF) inhibitors may have a lower risk of major cardiovascular (CV) events than those treated with methotrexate (MTX), according to a new study. “The findings do not surprise me. TNF inhibitors control inflammation better than methotrexate,” lead author Dr. Jashin J. Wu of Kaiser Permanente…

Update on Legislation, Notification Rules Concerning the Substitution of Interchangeable Biologic Drugs

From the College  |  November 16, 2016

Although the FDA has not yet awarded the title of interchangeable to any biosimilar, legislation that governs their substitution will continue to be a dominant state issue in 2017. Since 2013, 24 states and Puerto Rico have passed legislation regarding interchangeable biologics. As many as 15 states will have biosimilar-related legislation introduced by coalitions in…

Sarilumab Approval Stalled; Piclidenoson Promising for Psoriasis

Michele B. Kaufman, PharmD, BCGP  |  November 16, 2016

Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…

Second Biosimilar Equivalent to Adalimumab

Michele B. Kaufman, PharmD, BCGP  |  November 9, 2016

A recent study established the equivalency of BI 695501, a biosimilar, to its reference product, adalimumab, for treating patients with rheumatoid arthritis…

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