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EMA Restricts Tofacitinib Dosing
The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency issued recommendations limiting the use of Xeljanz (tofacitinib) 10 mg twice daily in patients with ulcerative colitis in the EU.
The new recommendations are temporary while PRAC undertakes a review of all available evidence on the safety and efficacy of tofacitinib. The review follows warnings of an increased risk of pulmonary embolism (PE) and death from the U.S. Food and Drug Administration based on Pfizer's large post-marketing safety study (in high risk rheumatoid arthritis patients with one or more underlying cardiovascular risk factors) wherein those receiving in tofacitinib 10 mg twice daily in study A3921133 had more PE and mortalities than comparator groups (tofacitinib 5 mg bid or adalimumab).
Opioids, SSRIs and Steroids Increase Fracture Risk in RA
Analysis of a large US observational rheumatoid arthritis (RA) patients finds that opioids, SSRIs and glucocorticoids were associated with increased risk of fracture in RA, whereas statins and TNFi had a decreased vertebral fracture risk.
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RheumNow Podcast – Richer or Poorer (5.17.19)
Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com
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Coexistent Gout Increases Risk in Rheumatoid Arthritis
It his often said that gout and rheumatoid arthritis (RA) cannot coexist and where confusion exists, a good history and testing for serum urate (SUA) and rheumatoid factor (RF) can usually clarify the dominant disorders. A recent study shows that hyperuricemia and gout are uncommon in RA, but when present shows an increased risk of comorbidities and cardiovascular (CV) mortality.
Risk Score Predicts Thrombosis Recurrence in APS
A combination risk score helped predict recurrent thrombosis -- particularly arterial -- among patients with antiphospholipid syndrome (APS), an international study found.
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FDA Final Guidance on Interchangeability with Biosimilars
The FDA has published an industry guidance document to define interchangeability as regards to biosimilar use in the United States under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)).
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Less Structural Damage with T2T in Gout
A two‐year randomized clinical trial has demonstrated that allopurinol dose escalation to a target serum urate (SU) results in less bone erosion, structural damage and urate crystal deposition in patients with gout.
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Methotrexate Use Not Linked to Interstitial Lung Disease in RA
People with rheumatoid arthritis have a significant risk of developing interstitial lung disease (RA-ILD), yet there is often a question as to whether methotrexate (MTX) exposure can cause or worsen ILD. A controlled cohort study suggests that MTX use is not associated with an increased ris
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Generic Price Fixing Alleged by State Prosecutors
The NY Times and 60 Minutes have reported that Connecticut, along with 43 other states, filed a mega-lawsuit accusing the generic drug makers of a massive, systematic conspiracy to bilk consumers out of billions of dollars.
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Low Serious Infection Risk with Newer Agents in Psoriasis
JAMA Dermatology reports on a comparative cohort study of 107,707 psoriasis patients, finding a decreased risk of serious infections among users of apremilast, etanercept, and ustekinumab when compared with methotrexate.
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RheumNow Podcast – Periodontitis in RA Relatives (5.10.19)
Dr. Jack Cush reviews the news and journal articles from the past week on RheumNow.com
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Gabapentinoid Drugs Overuse and Misuse
A recent article in JAMA by Drs. Goodman and Brett reviews the increasing off label use of gabapentinoid drugs, originally developed as antiseizure drugs that are now increasingly prescribed for painful conditions.
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Calcineurin Inhibitors in Anti-Synthetase Dermatomyositis ILD
A pilot treatment study of patients with anti-aminoacyl-tRNA synthetase antibody–positive polymyositis/dermatomyositis-associated interstitial lung disease (anti-ARS-PM/DM-ILD) shows therapy with glucocorticoids and calcineurin inhibitors (CNI) to be highly effective.
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Drug Pricing Regulations in US and Canada
Reuters reports on regulatory efforts by Canada and the US to curb the rising cost of drugs, especially expensive new medicines.
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Pilot Study Targets Insulin Resistence in Fibromyalgia
An unusual pilot study has shown that insulin resistence (IR), assessed by Hgb-A1c levels, was more prevalent in fibromyalgia (FM) patients compared to non-diabetic controls and that when FM patients were given metformin, half had complete resolution of their pain.
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Denosumab Protects Against RA Erosions
Combining denosumab (Prolia) with a conventional disease-modifying antirheumatic drug (DMARD) such as methotrexate showed promise for slowing radiographic damage in rheumatoid arthritis (RA), a manufacturer-sponsored phase III trial called DESIRABLE found.
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RheumNow Podcast – DESIREABLE Results (5.3.19)
Dr. Jack Cush reviews the latest journal articles and rheumatology news from the past week on RheumNow.com:
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Nonadherence is Costly for Patients in Pain
A comparative cohort study of patients with osteoarthritis (OA), gout, diabetic peripheral neuropathy (pDPN), post-herpetic neuralgia (PHN), and fibromyalgia (FM) shows that nonadherence to pain medications is high and leads to greater overall health care resource utilization and costs.
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Ideal Outcomes are Seldom Achieved in Gout
Studies from a cohort of gout patients in Mexico shows that long-term goals of a target serum urate (sUA) 6 mg/dL and remission are rare, especially for those with severe gout.
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Omega-3 Rich Fish Lowers Gout Flares
Boston researchers have shown that consumption of fish rich in omega‐3 polyunsaturated fatty acids (n‐3 PUFA) leads to a lower risk of recurrent gout flares.
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