Last year, the FDA was busy with new biologic and other drug approvals, new and expanded drug indications, and important safety updates relevant to rheumatology…
Remembering Etanercept & the Advent of the Biologic Era
As a veteran rheumatologist, I remember the clinical trials of etanercept’s (Enbrel’s) efficacy. And when the drug was first approved in 1998, I participated in those clinical trials and realized the effectiveness was astonishing. It was easy to tell which patients were treated with etanercept vs. those who received placebo, even though both groups were…
Risankizumab Demonstrates Superiority to Secukinumab for Plaque Psoriasis
In a phase 3, comparator study in adults with plaque psoriasis, patients taking
risankizumab achieved greater skin clearance than those taking secukinumab…
Biologic Spending & Price Trends
Any given rheumatology patient who needs a biologic disease-modifying anti-rheumatic drug (DMARD) will spend $22,000–44,000 on their medication each year…
Canada & E.U. Approve Upadacitinib for RA
Upadacitinib will soon be available to treat patients with moderate to severe rheumatoid arthritis in Canada and the E.U…
Denosumab Tied to Infection Risk
NEW YORK (Reuters Health)—The osteoporosis drug denosumab is associated with a higher incidence of serious infections compared with placebo, but the risk is similar to comparator drugs, a systematic review and meta-analysis reveals. Talia Diker-Cohen, MD, PhD, of Tel Aviv University, and colleagues searched the literature through May 2019 for randomized controlled trials of denosumab…
Novartis, Merck & Allergan Join Those Raising U.S. Drug Prices for 2020
NEW YORK (Reuters)—Novartis AG, Merck & Co Inc. and Allergan Plc. were among companies that raised U.S. prices on more than 100 prescription medicines on Jan. 4, bringing the tally to 445 drugs that will cost more in 2020, according to data analyzed by healthcare research firm 3 Axis Advisors. That is above the average…
Phase 3 Results for Ixekizumab Promising in Patients with Non-Radiographic Axial Spondyloarthritis
In a phase 3 study, ixekizumab proved safe and effective for improving the signs and symptoms of non-radiographic axial spondyloarthritis (axSpA) in combination with conventional background medications, such as NSAIDs…
EU Approves Remsima SC, a Biosimilar to Infliximab
Subcutaneous CT-P13 (Remsima SC), biosimilar to infliximab, will soon be available in the E.U. to treat adults with rheumatoid arthritis…
FDA Approves Nintedanib for SSc-ILD, But Temper Your Expectations
The U.S. Food & Drug Administration (FDA) approved nintedanib for systemic sclerosis associated interstitial lung disease (SSc-ILD) on Sept. 6 after a randomized, controlled trial (SENSCIS) demonstrated significant benefit against placebo.1 At a cost of $96,000 per year, treatment reduced the adjusted annual rate of change in forced vital capacity (FVC) from –93.3 mL in…
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