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Biologics/DMARDs

Biosimilars Seek Regulatory Approval in the U.S. & Europe; Plus MTX Underused in the U.S.

Michele B. Kaufman, PharmD, BCGP  |  January 6, 2016

In Europe, an etanercept biosimilar is getting closer to being approved to treat RA and more, and in the U.S., an application for an adalimumab biosimilar has been submitted for FDA approval. Also, an analysis of methotrexate use in the U.S. shows that therapy may actually be underused for RA…

Biologic DMARDs Prove Effective for Psoriatic Arthritis & Combination DMARDs Show Promise for RA

Michele B. Kaufman, PharmD, BCGP  |  December 25, 2015

In clinical trials, ixekizumab and adalimumab proved safe and effective in treating adults with active psoriatic arthritis. Also, the combination therapy of certolizumab pegol plus methotrexate was more effective than placebo for treating severe RA…

New SLE Drug May Allow Patients to Reduce Steroid Use

Michele B. Kaufman, PharmD, BCGP  |  December 16, 2015

In a recent study, the use of anifrolumab in SLE patients was shown to be safe and effective, enabling some patients to decrease their oral steroids. Also, secukinumab has been approved in Europe to treat ankylosing spondylitis and psoriatic arthritis…

Etanercept Biosimilars Promising in Clinical Studies

Michele B. Kaufman, PharmD, BCGP  |  December 2, 2015

In multiple clinical studies, investigational biosimilars for etanercept were shown to be safe and effective for treating rheumatoid arthritis and moderate to severe plaque psoriasis…

Amgen Files for U.S. Approval of Biosimilar

Bill Berkrot  |  November 29, 2015

(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…

Oxycodone Capsules Put on Hold; Clinical Trials for Lupus Nephritis & SLE Therapies

Michele B. Kaufman, PharmD, BCGP  |  November 25, 2015

Due to a lawsuit, the FDA has issued only tentative approval for an extended-release oxycodone capsule. Obinutuzumab is in clinical trials for lupus nephritis, and subcutaneous belimumab is being tested for SLE…

FDA Approves 2 Pain Drugs & New Gout Treatment on Road to Approval

Michele B. Kaufman, PharmD, BCGP  |  November 18, 2015

The FDA has approved two drugs designed to manage pain: buprenorphine for chronic pain and meloxicam capsules for OA pain. Lesurinad is also closer to FDA approval for treating gout…

Higher Tocilizumab Dose Plus Methotrexate Best for Early RA

Reuters Staff  |  November 14, 2015

NEW YORK (Reuters Health)—Tocilizumab improves remission rates and slows disease progression in patients with early rheumatoid arthritis (RA), a new randomized controlled trial demonstrates. Tocilizumab was effective both on its own and when combined with methotrexate, Dr. Gerd R. Burmester of Charite Medical University of Berlin and his colleagues found. Tocilizumab, an interleukin-6 (IL-6) blocker,…

RA Drug Tested & FDA Orders Drug-Interaction Studies for Kayexalate

Michele B. Kaufman, PharmD, BCGP  |  November 11, 2015

In multiple trials, baricitinib has proved promising for treating RA. Also, the FDA is requiring drug-interaction studies for sodium polystyrene sulfonate…

German Registry Evaluates Systemic Psoriasis Treatments

Michele B. Kaufman, PharmD, BCGP  |  November 4, 2015

The German Psoriasis Registry, PsoBest, found conventional systemic and biologic drugs for psoriasis demonstrated relative safety from serious adverse events in patients between January 2008–December 2012…

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