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).
Biosimilars continue to command a great deal of attention given the promise of significant cost savings and potentially wider use for those in need.
Systemic lupus is a clinically heterogeneous disorder, unified by requisite clinical features and exuberant humoral response to unknown triggers. While the diagnosis is easy, the disease course and management can be complicated and challenging.
One of the hallmarks of aggressive rheumatoid arthritis (RA) is presence of antibodies against citrullinated protein antigens (ACPA). ACPA often predates the onset of clinic symptoms and in majority of cases signifies more aggressive disease course with more erosive joint destruction and extra-articular disease manifestations in comparison with ACPA-negative patients.
In a retrospective cohort comparison study, 42,180 rheumatoid arthritis (RA) patients were compared 1:4 with 168,000 normal controls to examine the incidence of new tuberculosis in Taiwan. The RA population included those receiving csDMARDs (36,162), etanercept (3,577), adalimumab (1,678) and rituximab (763).
We physicians are clearly better at defining “too sick to work” in our patients than we are for ourselves. After pondering this ill issue, I’ve come up with some wisdom, goofiness and facts.
This week, when the FDA approved the biosimilar drug Inflectra as an alternative to infliximab (Remicade), it was only the second biosimilar to be granted approval in the United States, and was the first monoclonal antibody biosimilar.
Methotrexate (MTX) is a highly favored drug in rheumatology. Yet it has numerous nuisance side effects that may limit its use or patient acceptance.
In March 2016, RheumNow published 82 social media “tweets” regarding news, research and teaching points that impact the rheumatology community. These feeds had a reach (impressions) of 86,400 with, 76 mentions, and over 2700 visits to learn on RheumNow.com. The average daily “tweet” from RheumNow is seen by 3000-8,000, with as many as 89,500 viewers from a single tweet.
Dr. Jack Cush reviews the rheumatology highlights from the news, media, and journals from this past week:
Previous research has suggested a potential role for gut dysbiosis and alterations Th17 and regulatory T (Treg), along with IL-17, IL-22, and IL-23, in the pathogenesis of SLE.
Lopez and colleagues from Spain have studied the gut microbiome of lupus patients and reported that lupus microbiota promoted lymphocyte activation and Th17 differentiation from naïve CD4+ lymphocytes moreso than
The GAUSS-3 trial, recently published in JAMA, examined cholesterol-lowering interventions in patients with a high LDL (>120 mg/dl) and a history of statin intolerance to 2 or more statins.
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.
It is estimated that 21% of laboratory tests are requested inappropriately. Researchers have explored the impact of educational programs for rheumatologists working at three rheumatology departments in secondary and tertiary care centers in The Netherlands.
Pfizer has issued a press release of its preliminary results from the OPAL study that examined the efficacy and safety of tofacitinib 5 mg and 10 mg twice daily (BID) in adults active psoriatic arthritis (PsA).
422 PsA patients, on background DMARD therapy, were randomized to receive tofacitinib (5 mg or 10 mg BID), adalimumab 40 mg q2 wk (active control) or placebo in a phase III trial.
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.
