Turnabout for Baricitinib

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Eli Lilly and Company and Incyte Corporation announced today that, after discussions with the U.S. Food and Drug Administration in late August 2017, Lilly will resubmit a revised New Drug Application for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data. 

Shingles Vaccine Studies in A&R

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The current issue of Arthritis & Rheumatology features an editorial and two novel articles on the herpes zoster vaccine.

Canakinumab Reduces CV Outcomes in High Risk Patients

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The results of a randomized, double-blind trial have shown that canakinumab (CAN), an interleukin-1β inhibitor, given as 150 mg every 3 months, resulted in a significantly lower rate of recurrent cardiovascular events (in high-risk CV patients), independent of lipid-level lowering. The results of the CANTOS studywere simultaneously published in NEJM, Lancet and were presented at the European Society of Cardiology meeting in Barcelona.

Another Adalimumab Biosimilar Approved

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On Friday August 25th, the FDA approved another adalimumab biosimilar: Cyltezo (generic name: adalimumab-adbm).

Adalimumab Biosimilars Adding Up

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Reuters reports that yet another adalimumab biosimilar has been approved by European Union regulators.

The new drug is named Imraldi, and is manufactured by Samsung Bioepis, a company who has several biosimilars approved or in development for worldwide use.

It's Rheumatoid Arthritis, not the TNF inhibitor, that Drives Lymphoma Risk

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Evidence from multiple studies suggests there is an increased risk of lymphoma in rheumatoid arthritis (RA) that is believed to be linked to the cumulative activity of the disease.  

Therapeutic Update: 5 Questions on FDA Hearing for Tofacitinib in PsA

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In this Therapeutic Update, Drs. Mease, Gibofsky and Cush answer five questions regarding the August 3rd FDA Arthritis Advisory Committee meeting that reviewed the potential approval of tofacitinib (Xeljanz) in patients with active psoriatic arthritis. The panel was nearly unanimous (10-1) in favor of the efficacy and safety profile of of tofacitinib, and similarly voted 10-1 to approve this drug for use in PsA. Final decisions on these recommendations from the AAC panel will be made at a later date by the FDA. 

Pegloticase Infusion Reactions Largely Seen in Non-Responders

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The introduction of intravenous pegloticase (PEG) in 2010 was felt by many to be a major advance in the treatment of patients with severe, refractory tophaceous gout.  But for some, concerns over infusion reactions and safety have limited its use.

No Evidence to Support Use of Gabapentinoids in Low Back Pain

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Management of chronic low back pain (CLBP) is often complex, requiring multiple modalities and meds to control pain. An analysis of studies shows that Gabapentinoids, including pregabalin and gabapentin, have little to no benefits but significant risk of adverse effects.

Marijuana Has Little Effect on Most Types of Pain

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Cannabis has become a regulated product, and many states have made it available with the intent of treating a variety of medical disorders, including chronic pain. A metanalysis published in Annals of Internal Medicine has shown that while cannabis may help neuropathic pain, it is not proven to benefit other types of chronic pain.

The RheumNow Week in Review – 11 August 2017

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The RheumNow Week in Review caps the week's news every Friday. Dr Jack Cush reviews the news, journal reports and important events from the past week in rheumatology.

Therapeutic Update: 5 Questions on Sirukumab FDA Hearing

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Drs. Cush and Gibofsky answer 5 questions about the August 2, 2017 FDA Arthritis Advisory Committee meeting that reviewed the NDA for sirukumab use in rheumatoid arthritis. The panel voted against (1-12) the approval of sirukumab.

FDA Arthritis Advisory Panel Endorses Tofacitinib Approval for Psoriatic Arthritis

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On Thursday, August 3, the FDA Arthritis Advisory Committee (AAC) met to consider tofacitinib for use in patients with psoriatic arthritis. The panel voted 10-1 in favor of approval.

The RheumNow Week in Review – 4 August 2017

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Dr. Jack Cush reviews new FDA decisions on sirukumab and tofacitinib as well as other news items from the past week on RheumNow.com. 

Arthritis Advisory Panel Votes Down Sirukumab

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On Wednesday, August 2, the FDA convened the Arthritis Advisory Committee (AAC) to evaluate the safety and efficacy of Janssen’s anti-IL-6 monoclonal antibody, sirukumab.

Pediatric Consensus on Comorbidity Assessments

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Comorbidity is a serious consequence or confounder in patients with inflammatory diseases. This has been well described in both psoriatic and rheumatoid disease.

No Increase in Malformations with Etanercept Use During Pregnancy

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While there are several reports detailing uncontrolled, observational results of biologic use during pregnancy, most are hampered by low numbers, incomplete data and too small a sample to make reliable judgements regarding the teratogenicity.  A company sponsored claims data analysis has shown that etanercept exposure during pregnancy was not associated with an increase in major congenital malformations (MCMs).

Romosuzumab Outperforms Teriparatide in Post-Bisphosphonate Osteoporosis

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The STRUCTURE trial results have been reported in Lancet and have shown that after 12 months of therapy, romosozumab (ROMO) had superior gains in bone mineral density (BMD) compared to teriparatide (TER) in women with postmenopausal osteoporosis who have previously taken bisphosphonate therapy.

One-Third of Americans Took Opioids in 2015

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 In the wake of the well-publicized "opioid epidemic", researchers report in the Annals of Internal Medicine (online July 31) that more than one third of U.S.

August 2nd AAC Meeting: FDA Concerns Over Sirukumab Deaths

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On August 2, the US Food and Drug Administration (FDA) will convene a hearing of the Arthritis Advisory Committee (AAC) to review the safety of the novel IL-6 inhibitor, sirukumab, being developed by Janssen (Johnson & Johnson).