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Post-Approval Exploratory Trials with Pregabalin Often Fail

d Jack Cush, MD

A systematic review of 238 pregabalin (Lyrica) trials for nonapproved indications shows that nearly two-thirds yielded uncertain evidence of efficacy, thereby questioning the off-label use or endorsement in clinical practice guidelines.

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FDA Approves Biosimilar Rituximab for NHL, not RA

d Jack Cush, MD

The U.S. Food and Drug Administration on Wednesday approved Celltrion biosimilar of rituximab called Truxima; previously called CT-P10, now generically labeled as rituximab-abbs. This is the first biosimilar to the Rituxan currently approved to treat non-Hodgkin’s lymphoma. Truxima is not approved for use in rheumatoid arthritis, vasculitis, pemphigus vulgaris or chronic lymphocytic leukemia.

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Hepatic Safety of Urate Lowering Therapies in Gout

d Jack Cush, MD

Lee and a group of Korean investigators have analyzed the comparative safety of allopurinol and febuxostat in a small cohort of gout patients with fatty liver disease (FLD) and found febuxostat had a lower risk for hepatotoxicity (defined as AST or ALT at least 3× the upper limit of normal)

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Diagnosing Early Lupus from Mimics

d Jack Cush, MD

A multicenter study of early systemic lupus erythematosus (SLE) patients examined manifestations at disease onset and found that certain clinical features can help to distinguish early SLE from other SLE‐mimicking conditions. 

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High CV Risk in Lupus

d RheumNow

Patients with systemic lupus erythematosus (SLE) remain at risk for accelerated atherosclerosis, and important questions have yet to be answered, British investigators reported.

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Trazodone High Risk of Falls and Fractures

d Jack Cush, MD

The CMAJ (Canadian Medical Association Journal) has reported that trazadone use in the elderly may be associated with a risk of falls and major fractures. 

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UK's NHS has spent £400million on Humira for 46,000 UK patients and starting in December will replace it with biosimilars of adalimumab at a cost of £100million https://t.co/jYzHi2pxrB

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Study of 2053 RA patients from VA medical centers found 27% with chronic lung disease that confered a 51% increased mortality risk that was not altered by MTX or biologic therapy. https://t.co/nYFnScSXQ4

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Amongst 192 patients w/ ANCA Assoc. vasculitis there were 95 severe infections (25%; 26/100PYs). TMP/SMX prophylaxis lowered risk of severe infections by 70% (HR 0.30). Risk was higher w/ age, bronchiectasis, endobronchial dz, COPD. https://t.co/aDEGNuwsEH

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FDA has approved Genentechs ACTpen - a tocilizumab autoinjector 162 mg sc for use in RA, GCA, poly & systemic JIA - should be available in January 2019. https://t.co/YzFHyYxQlS

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A systematic literature review shows that triple positivity for ACPAs, RF, and anti‐CarP antibodies yields a higher specificity for RA (98–100%), accompanied by a lower sensitivity (11–39%). https://t.co/TKAZd7CP1M

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Claims data study from Germany looked at OA of hip or knee in adults > 60 yrs finding 595,754 pts (mean 75 yrs; 70% female) Dx with OA (21.8%); 63% received analgesics, higher with increasing age. PT in 43.1% and 5.3% w/ joint replacement in 2014. https://t.co/shLSlDeO9h

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CDC review of new syndrome Acute Flaccid Myelitis - 106 cases in 2018, mostly white (86%), children (median 4 yrs) w/ rapid onset of flaccid weakness in one or more limbs and spinal cord gray matter lesions. Evidence suggests a viral association. https://t.co/C5FHAHMHI9

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Dr. John Cush RheumNow ( View Tweet)

Clinical Expectations of Biosimilars is one of several educational videos available in the "Therapeutic Update: Biosimilars in Rheumatology" video series, sponsored by Sandoz, Inc. and now available on RheumNow. https://t.co/1vmnEJqOSi

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Dr. John Cush RheumNow ( View Tweet)

Musculoskeletal/Rheumatic diseases (arthralgias, myalgias, arthritis, PMR, myositis, Sjogrens, SLE) are uncommon side effects of immune checkpoint inhibitors, so-called irAE (immune related adverse events). Good review here. https://t.co/R52SW0HUjv

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Despite many excellent therapies, most patients with gout are not adequately managed, and patients and providers have many misconceptions about gout. Great review by Ted Fields, MD https://t.co/Njpo1225XP

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Dr. John Cush RheumNow ( View Tweet)

Bisphosphonate safety review - risk of Atypical Femoral Fracture is 1/1000 and risk of osteonecrosis of the jaw is 1/10,000. One-third of IV zolendronic acid pts will have arthralgia/myalgias or flu like sxs. https://t.co/80xBkZlKgn

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Dr. John Cush RheumNow ( View Tweet)

TB Testing 2 - Note: <10% of pts initially PPD/IGRA neg may be positive later (either they were anergic or have a new TB infx). I Recommend repeat TB testing 3 mos after starting or changing from 1st to 2nd biologic - Repeat testing indicated if newly EXPOSED or when Risk Changes

Dr. John Cush RheumNow ( View Tweet)

TB Testing - Do PPD or IGRA before TNFi or biologic - If negative, start therapy - If Positive, Eval for active TB (Sxs, CXR, C/S); if neg --> LTBI Rx BEFORE biologic - If "Indeterminate", repeat or change test. If same or neg--> start biologic - Do not do annual TST or IGRA

Dr. John Cush RheumNow ( View Tweet)

Metanalysis shows DMARDs (6 studies) and biologics (5 studies) offer NO clinically significant benefit compared with placebo in Osteoarthritis. https://t.co/fNGVzuNQNo

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