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ORBIT Study Shows Rituximab and TNF inhibitor Equivalence
The initial choice of biologic is crucial to long-term success. Yet there are few studies evaluating head-to-head differences in some of our most popular therapies.
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FDA Delays Ruling on Generic Labeling
The New York Times reports that the FDA has delayed its much anticipated ruling on generics until sometime in 2017.
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Risk Factors for Bisphosphonate Bone Complications
Rare reports of bisphosphonate associated atypical femoral fractures (AFF) and osteonecrosis of the jaw (ONJ) have raised concerns about the chronic use of bisphosphonates. The risk of AFF and ONJ was assessed in an analysis of the Swedish national database.
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Reports Call for More Gout Education
Two recent surveys show that gout patients are often uninformed, undertreated, improperly monitored and frequently stigmatized by their gout.
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Cochrane Reports Moderate Evidence Favoring Biologic Add-on Therapy
Singh and coworkers have assessed the value of adding a biologic to rheumatoid arthritis (RA) patients not responding to either methotrexate (MTX) or DMARDs. The results of their netowork metanalsysis is published as a Cochrane review wherein they examined a total of 90 RCTs (73 new) with 32
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Secukinumab Improves Patient-Reported Outcomes in Psoriatic Arthritis (FUTURE 1)
Secukinumab (Cosentyx) has recently been approved for use in ankylosing spondylitis and psoriatic arthritis; the latter largely based on the FUTURE 2 and the just reported FUTURE 1 clinical trial. FUTURE 1 demonstrates the efficacy and safety of secukinumab, with inital weekly intravenous loading, given monthly as a subcutaneous injection.
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Generics Surge the Market
Generics are being approved at a record-setting pace. Thanks to the 2012 FDA Safety and Innovation Act, there are new funds generated by manufacturers' fees for drug applications to hasten the approval of generics. In 2015 alone, the FDA has approved 580 generic drugs – the highest number on record – while another 146 were granted tentative approval.
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Curbside Consults - May 2016
How would you manage rheumatoid arthritis patients with melanoma in situ, or high liver enzymes or interstitial lung disease? Curbside consults takes on these challenging therapeutic or safety issues with answers are based on experience, literature and guidelines.
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FDA REMS/Safety Panel Backs Educational Requirements for Opioid Prescribers
An advisory panel to the Food and Drug Administration met May 3rd and 4th to review whether the long-acting or extended release (ER/LA) opioid REMS programs approved in 2012 have had a meaningful effect on the opioid abuse problems noted nationwide. The FDA panel voted overwhelming
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Biosimilar Switching Shows Favorable Interchangeability
Interchangeability is a major issue that will determine the success of biosimilars.
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Low Adherence to Biologics in Psoriasis Patients
Doshi and colleagues have conducted a retrospective claims analysis (2009 through 2012) of psoriasis patients on Medicare to examine the use and adherence to those initiating treatment with either infliximab, etanercept, adalimumab, or ustekinumab.
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RheumNow Week in Review – 22 April 2016
Watch Dr. Jack Cush cover ten highlights from this week on RheumNow.com.
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Biosimilar Reports - April 2016
Major advances in biosimilars have occurred in the last three months, beginning with the FDA Arthritis Advisory Committee voting 21-3 to approve Celltrion’s Inflectra (CT-P13) and ending with the recent approval of Inflectra (generically referred to as infliximab dyyb).
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Intraarticular Wnt Inhibitor Therapy Effective in Knee Osteoarthritis
At the 2016 World Congress on Osteoarthritis (OARSI) meeting last week, first line results of a novel intraarticular inhibitor of the Wnt pathway (SM04690) in knee osteoarthritis were presented.
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FDA Biosimilar Approval of Inflectra Viewed as a Milestone Advance
On February 9th, the Food and Drug Administration (FDA) Arthritis Advisory Committee voted 21-3 in favor of approving the infliximab biosimilar, CT-P13/Inflectra, for use in all of infliximab's indications.
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1 in 2 Americans Have Musculoskeletal Conditions
A recent report from the United States Bone and Joint Initiative (USBJI) estimates that 126.6 million Americans (one in two adults) are affected by a musculoskeletal (MSK) condition; a number on par with the number of Americans living with a chronic lung or heart conditions.
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First Head-to-Head TNF Trial Ends in a Draw
Comparative efficacy trials may be the best way to make informed treatment choices in a sea of treatment options for rheumatoid arthritis (RA). Recent years have seen impressive head-to-head (H2H) clinical trials for RA, including AMPLE (abatacept vs.
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Bisphosphonate Use Falls Following FDA Warnings
In the current issue of JBMR, Kim and colleagues from Brigham and Women's Hospital in Boston assessed US claims data and studied the impact of three FDA drug safety warnings regarding the use of bisphosphonates.
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Biosimilars Reviewed by Expert Panel
As the number of biosimilars in development keeps on growing, reaching nearly 700 products to date, demand for data from randomized controlled trials (RCTs) and an understanding of these new biologics is peaking the interest of many.
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ASAS: MRI Definition of Active Sacroiliitis
Increased use of MRI for diagnosis of spondyloarthritis (SpA) in the last two decades has led to earlier diagnoses and gradual incorporation of MRI into the SpA assessment toolset.
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