Vitamin D, Omega-3s May Boost DMARD Response in Early RA

The researchers aimed to evaluate the association between dietary vitamin D, omega-3 fatty acids, and treatment outcomes with DMARDs in patients with rheumatoid arthritis.

Drug Combo Effective for Tophaceous Gout

When lesinurad 400mg was added to febuxostat, significantly more patients achieved target sUA by Month 6 (76.1%; P<0.0001) vs. febuxostat alone (46.8%); however, this was not seen with adding lesinurad 200mg (56.6%; P=0.13).

FDA Approves New Administration Option for Orencia in pJIA

The approval of the prefilled syringe was based on dosing, efficacy, and safety data of SC abatacept in JIA among patients aged 2-17 years with inadequate response to at least one nonbiologic or biologic DMARD (Study JIA-2).

Higher Alcohol Intake May Up Muscle Loss, Function for Some Women

The data showed sarcopenia was 4 times more prevalent for the high-risk alcohol drinking group vs. the low-risk alcohol drinking group (odds ratio 4.29, 95% CI: 1.87, 9.82).

Case: Inhaled Corticosteroid-Induced Myopathy in HIV Patient

Initially, the team attributed the muscle weakness to either HIV or drug-mediated myopathy but a muscle biopsy later revealed atrophy of type II fibers without necrosis or inflammation.

Recall: CV Meds Found to Contain Gout Pills

Accidental patient dosing with Zurampic can potentially cause adverse renal effects such as acute renal failure; this is more common if Zurampic is given alone without a xanthine oxidase inhibitor.

Kevzara Available for the Treatment of Rheumatoid Arthritis

Kevzara (sarilumab) injection has been approved for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs.

Giant Cell Arteritis Treatment Gets FDA Approval

In the study, Actemra given weekly and bi-weekly combined with a 6-month glucocorticoid regimen, more effectively sustained remission through Week 52 than placebo combined with a 26-week steroid taper and a 52-week steroid taper.

AACE/ACE: New ACP Osteoporosis Guidelines 'Fall Short'

Five important differences were identified by AACE/ACE involving pharmacotherapy choice as well as treatment duration and reevaluation.

Are Corticosteroid Injections Beneficial for Knee Osteoarthritis?

The researchers found that at the end of the study, pain levels didn't differ significantly between the patient who received intra-articular triamcinolone or saline.

Xeljanz Under FDA Review for Psoriatic Arthritis

An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.

Are Statin Users at Greater Risk for Back Disorders?

Previous research has demonstrated a link between statin use and use-related injury and arthropathies.

Bone Building Drug Gets FDA Approval for Osteoporosis

Abaloparatide is a parathyroid hormone related peptide [PTHrP(1-34)] analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells.

Powder Form of Ilaris Permanently Discontinued

Ilaris for Injection will be replaced by Ilaris Injection (solution) for subcutaneous use.

FDA to Review BLA Resubmission of Rheumatoid Arthritis Biologic

The FDA has accepted for review the resubmission of the Biologics License Application (BLA) for Kevzara (sarilumab; Regeneron and Sanofi) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs.

Report Sheds Light on Physician Compensation by Location, Gender

Which cities report the highest physician compensation?

Xatmep Approved for Pediatric Patients with pJIA, ALL

To date, there is no approved oral liquid formulation of methotrexate for pediatric patients who require body surface area (BSA) dosing or who have difficulty swallowing or cannot ingest tablets or those with needle-phobia.

Spinraza Beneficial in Later-Onset Spinal Muscular Atrophy

The CHERISH study was a multicenter, randomized, double-blind, sham-procedure controlled study to evaluate the safety and efficacy of Spinraza in children with later-onset SMA (n=126) aged 2-12 years.

Biosimilar Renflexis Gets FDA Approval

A biosimilar product must demonstrate no clinically meaningful differences in safety or efficacy from the reference product.

Movement Disorders Examined in Current, Past Stimulant Drug Users

The researchers concluded that stimulant drug use may result in acute stimulant-induced tremor as well as long-term proprioceptive deficits in terms of arm-droop.

Second-Line Tx Options Explored for RA Patients with MTX Failure

The data overall showed favorable ACR and EULAR response criteria, DAS28, and modified Sharp scores with anti-TNF agents + methotrexate, with no difference with HAQ and rates of adverse events between the treatment groups.

FDA Requires More Data Before Baricitinib Approval

The NDA for baricitinib was submitted in January 2016 and a 3-month extension for time to review additional analyses was announced in January 2017.

Do Uric Acid Lowering Drugs Reduce BP in Hypertensive Patients?

In general, there was low quality evidence from three trials indicating no reduction in systolic (-6.2mmHg, 95% CI: -12.8 to 0.5) or diastolic (-3.9mmHg, 95% CI: -9.2 to 1.4) 24-hour ambulatory BP with uric acid lowering drugs vs. placebo.

First Drug for Tardive Dyskinesia Gains Approval

The FDA approval was based on efficacy data of Ingrezza in a 6-week clinical study (n=234) of patients who received Ingrezza vs. placebo.

Postmenopausal Osteoporosis Drug Shows Long-Term Safety

Researchers evaluated the incidences of adverse events in women who initially received placebo during the FREEDOM trial and then received denosumab for up to 3 years during the FREEDOM Extension trial.

Amgen Looks to Expand Xgeva Use to Multiple Myeloma Patients

The study met its primary endpoint of Xgeva non-inferiority versus zoledronic acid in delaying the time to first on-study SRE in multiple myeloma patients (HR=0.98, 95% CI: 0.85, 1.14; P=0.01).

Amount of Vitamin D Needed May Be Less than What's Recommended

"This has important ramifications for public health recommendations," said Christopher Gallagher, MD, professor and director of the Bone Metabolism Unit in the Division of Endocrinology of Creighton University School of Medicine.

Experimental Device Helps Paralyzed Man Feed Himself

Researchers utilized functional electric stimulation intracortical brain-computer interface system

SSRI Use Tied to Improved Joint Replacement Sx Outcomes

SSRIs users had significantly lower risk of revisions and aseptic revisions compared to those who were not administered an SSRI.

Alexion Seeks Eculizumab Approval for Ultra-Rare Neuromuscular Disease

The submission is supported by data from the Phase 3 REGAIN study, a randomized, double-blind, placebo-controlled trial which enrolled a total of 125 patients with anti-AChR Abs.

Study Investigates Transfer of TNFi Therapy to Breast Milk

A study which assessed concentrations of certolizumab pegol (Cimzia; UCB) in human breast milk found that minimal to no transfer of drug from plasma to breast milk occurs.

Pain Management Goals Differ for Physicians, Patients

Patients and physicians have substantially different goals when it comes to chronic musculoskeletal pain management, however these differences do not predict patient experience or physician-reported visit difficulty.

Does Tocilizumab Raise CV Risk in RA Patients?

Tocilizumab is known to raise LDL cholesterol levels but it is unclear whether the drug raises CV risk in RA patients.

Resolaris Granted Orphan Drug Status for Rare Genetic Myopathy

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma) for the treatment of limb girdle muscular dystrophy (LGMD).

Tofacitinib Goes Head-to-Head with Adalimumab in RA Study

Tofacitinib plus MTX was shown to be non-inferiority vs. adalimumab plus MTX, however, Xeljanz monotherapy did not meet its primary endpoint for non-inferiority vs.adalimumab plus MTX, or vs. Xeljanz plus MTX.

Low Back Pain Treatment Guidelines Released

The recommendations are intended for all clinicians treating adult patients with acute, suabcute, or chronic low back pain.

Is Diazepam Beneficial in Acute Low Back Pain?

In the U.S., diazepam is prescribed in approximately 300,000 visits for low back pain annually, however the evidence regarding its efficacy is surprisingly lacking.

Can Yoga Improve Nonspecific Low Back Pain, Function?

For patients experiencing low back pain, yoga may be an effective pain reliever, according to a review published online January 12 in The Cochrane Library.

Emflaza Approved for Duchenne Muscular Dystrophy

The Food and Drug Administration (FDA) has approved Emflaza (deflazacort; Marathon) tablets and oral suspension for the treatment of Duchenne muscular dystrophy (DMD) in patients aged 5 years and older.

Shift in Bisphosphonate Use with Revised Osteoporosis Recommendations

In response to revised osteoporosis recommendations in 2008, there was a shift in age-related trends in oral bisphosphonate (BP) therapy initiation, according to a study published online February 2 in the Journal of the American Geriatrics Society.

Etanercept vs. Monoclonal Antibody Tx Assessed in Rheumatoid Arthritis

For patients with rheumatoid arthritis, etanercept is associated with lower risk for general infections and tuberculosis compared with monoclonal antibody treatment, according to a meta-analysis published online Feb. 3 in the International Journal of Rheumatic Diseases.

FDA Accepts Zilretta NDA for Osteoarthritis Knee Pain

The FDA has accepted for review the New Drug Application (NDA) for Zilretta (FX006; Flexion Therapeutics) for the treatment of patients with osteoarthritis (OA) of the knee.

Polypharmacy and Frailty: What's the Link?

Older adults who take multiple medications may be twice as likely to become frail in a relatively short period of time (3 years) compared to those who take fewer medications.

Many Factors Involved in High Rate of Low Back Pain Among Children

Low back pain is common in school-age American children, and rates increase with age, according to a study published online January 30 in JAMA Pediatrics.

New Position Paper on Screening for Osteoporosis Therapy Adherence Published

The International Osteoporosis Foundation and European Calcified Tissue Society Working Group proposed a screening strategy measuring certain bone turnover markers in patients who have initiated oral bisphosphonate therapy for postmenopausal osteoporosis as a practical way to identify low adherence.

High-Inflammation Diets May Impact Fracture Risk

An anti-inflammatory diet may protect women against bone density loss and decrease the risk of hip fracture, according to data taken from the Women's Health Initiative (WHI).

Tocilizumab Gets Priority Review for Treatment of Giant Cell Arteritis

Genentech has announced that the Food and Drug Administration (FDA) has accepted the company's Supplmental New Drug Application (sBLA) for Actemra (tocilizumab) to treat giant cell arteritis (GCA).

Spinal Cord Stimulation May Cut Opioid Use in Chronic Pain

Spinal cord stimulation was found to help decrease or stabilize opioid use in patients with chronic pain.

New Point-of-Care Device Helps to Detect Osteoporosis

Bone Index announced that the Food and Drug Administration (FDA) has granted clearance for the second generation Bindex device model to aid in the diagnosis of osteoporosis.

How Behavior Could Quicken DNA Aging by 8-Years

A sedentary lifestyle may accelerate biological aging, according to a study published online January 18 in the American Journal of Epidemiology.

Body Dysmorphic Disorder Often Not ID'd by Plastic Surgeons

Nearly one in 10 patients seeking facial plastic surgery suffers from body dysmorphic disorder (BDD), but doctors often don't spot the problem, according to research published online recently in JAMA Facial Plastic Surgery.

Muscular Dystrophy Treatment Gets Fast Track Designation

aTyr announced that its candidate Resolaris has been granted Fast Track designation for the treatment of limb girdle muscular dystrophy 2B (LGMD2B), by the Food and Drug Administration (FDA). The FDA also removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials.

First-of-its-Kind Muscle Activation Therapy Cleared by FDA

CyMedica Orthopedics announced that the Food and Drug Administration (FDA) has granted clearance for e-vive, an app-controlled, data-driven muscle activation therapy and patient engagement solution.

Intervention vs. Usual Care for Osteoarthritis Outcomes

Patient- and provider-based interventions do not improve osteoarthritis outcomes, according to a study published online January 17 in the Annals of Internal Medicine.

Spinraza Shown to Cut Risk of Permanent Ventilation, Death in SMA

Biogen announced new data from the Phase 3 ENDEAR study that showed a statistically significant reduction in the risk of death or permanent ventilation in Spinraza (nusinersen)-treated infants with spinal muscular atrophy (SMA) vs. untreated infants.

Do Concomitant Neuropathic Pain Meds Impact Pregabalin Efficacy?

The therapeutic efficacy of pregabalin in treating two types neuropathic pain (NeP) is not influenced by concomitant NeP medications, according to new research published in the journal Pain Physician.

Can Being a 'Weekend Warrior' Reduce Mortality Risk?

Weekend warriors may add almost as many years to their life span as those who work out all week long, according to research published online in JAMA Internal Medicine.

Chondroitin Sulfate vs. Celecoxib Data Announced for Knee OA

Bioberica announced positive results from the MOSAIC Study that evaluated the use of chondroitin sulfate for knee osteoarthritis.

Soliris Application Seeks Ultra-Rare Neuromuscular Disease Indication

Alexion has submitted a marketing application to the Food and Drug Administration (FDA) to extend the indication for Soliris (eculizumab) to be a treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

Do Bisphosphonates Cause Atypical Femur Fractures in OI?

Data from a retrospective study of children with osteogenesis imperfecta (OI) suggests that atypical femur fractures are related to the severity of OI vs. use of bisphosphonates. Findings from the study are published in the Journal of Bone and Mineral Research.

Dual-Mechanism Gout Treatment Under FDA Review

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Duzallo (lesinurad/allopurinol fixed-dose combination; Ironwood) for the treatment of hyperuricemia in patients with uncontrolled gout.

First Treatment for Spinal Muscular Atrophy Gets FDA Approval

The approval was based on positive data from multiple clinical studies involving >170 patients.

BD Introduces New 2.25mL Prefillable Glass Syringes for Biologics

BD announced the launch of BD Neopak 2.25mL prefillable glass syringes intended for biopharmaceutical manufacturers that handle high-value and sensitive biologic agents that require higher quality levels and performance to treat rheumatoid arthritis, psoriasis, lupus, severe asthma, and other chronic conditions.

FDA Approves Unique Treatment for Knee Cartilage Repair

The Food and Drug Administration (FDA) has approved Maci (autologous cultured chondrocytes on porcine collagen membrane; Vericel) for the repair of symptomatic, full-thickness cartilage defects of the knee in adults.

NDA Submitted for Novel Knee Osteoarthritis Pain Treatment

Flexion has submitted a new drug application (NDA) to the Food and Drug Administration (FDA) for Zilretta (FX006), a potential treatment for patients with osteoarthritis (OA) of the knee.

AAOS: New Treatment Criteria for Carpal Tunnel Syndrome, Knee OA

The American Academy of Orthopaedic Surgeons (AAOS) approved new Appropriate Use Criteria (AUC) for the management of carpal tunnel syndrome and the surgical management of osteoarthritis of the knee.

Review Finds Gout Therapy Monitoring 'Suboptimal' Among Veterans

A retrospective chart review found that rates of urate-lowering therapy monitoring among United States veterans with gout were less than optimal. The full findings are published in the Annals of Pharmacotherapy.

Postmenopausal Osteoporosis Treatment Discontinued

The Food and Drug Administration (FDA) has posted a discontinuation notice for Miacalcin Nasal Spray (calcitonin-salmon; Mylan).

Osteoporosis Drugs Compared for Fracture Prevention

Among the pharmacological treatments for osteoporosis studied, teriparatide appeared to be most effective in preventing new non-vertebral fractures, according to new research published in Cell Physiology and Biochemistry.

Review: A Pragmatic Approach to Tapering Biologics in RA

The researchers identified six key pieces of information that may help clinicians in selecting the optimal patient for successful de-escalation of biologic DMARD.

Impact of Anti-TNF-Alpha Drugs on Pregnancy-Related Outcomes

Women with immune-mediated diseases receiving anti-tumor necrosis factor (TNF)-alpha agents had significantly higher risks of preterm birth, spontaneous abortion, and low birth weight vs. the general population, a study published in the Journal of Autoimmunity found.

Prescribing Practice Data Show Methotrexate Underutilized in RA

Methotrexate (MTX), the anchor drug in rheumatoid arthritis (RA) treatment, is currently being underutilized in the U.S., with suboptimal dosing, inadequate duration of therapy, and failure to use subcutaneous administration.

Review: Biologic Monotherapy Compared to Traditional DMARDs for RA

The analysis focused on comparing the benefits and risks of biologic monotherapy, non-TNF agents, or tofacitinib monotherapy vs. placebo or methotrexate/other DMARDs.

Benzodiazepine Users May Be at Increased Risk for Hip Fracture

Benzodiazepines and related drugs were found to increase the risk of hip fracture in patients with Alzheimer's disease.

Treatment for Painful Foot Nerve Disorder Gets Fast Track Designation

Centrexion announced that the Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975, a novel therapy intended to treat Morton's neuroma.

Celecoxib-Associated CVD Risk Compared to Other NSAIDs in Landmark Study

For osteoarthritis or rheumatoid arthritis patients at high risk for cardiovascular disease (CVD), celecoxib, ibuprofen and naproxen carry a similar CVD risk, according to newly released results from the PRECISION trial.

Does Fracture Risk Go Up After Stopping Hormone Therapy?

For women who are former hormone therapy users, risk of fracture is not increased after discontinuing therapy, according to a study published in the The Journal of Clinical Endocrinology & Metabolism.

For RA Patients, DMARDs May Protect Against Bone Loss

A new review has found disease-modifying anti-rheumatic drugs (DMARDs) to be effective in halting progressive bone loss in rheumatoid arthritis (RA) patients, and suggests that they should be used early in treatment.

Spinraza Improves Motor Function in Spinal Muscular Atrophy Study

Biogen and Ionis have announced positive results from the Phase 3 study of Spinraza (nusinersen), an investigational treatment for spinal muscular atrophy (SMA) in children.

Review Looks at Effective Treatments for Gout Management

A treatment review for acute gout attacks and management has found strong evidence that colchicine, NSAIDs, and corticosteroids are effective in relieving pain in acute gout patients.

FDA to Review Treatment for Levodopa-Induced Dyskinesia

Adamas announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, to potentially treat levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

New DMD Drug Candidate Designated Orphan Drug

Solid Biosciences and Solid GT announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for SGT-001 for the treatment of patients with Duchenne muscular dystrophy (DMD).

Treatment for Rare Genetic Myopathy Gets Fast Track Designation

ATyr Pharma has announced that Resolaris, an investigational treatment for facioscapulohumeral muscular dystrophy (FSHD), has been granted Fast Track status by the Food and Drug Administration (FDA).

Biosimilar Inflectra Now Available

Pfizer announced that Inflectra (infliximab-dyyb) for injection will be shipped to wholesalers in late November 2016.

Heavy Cannabis Use Tied to Decreased Bone Density

Heavy cannabis smokers have lesser bone density than cigarette smokers and are prone to more fractures. That's according to a new analysis of 170 regular cannabis smokers and 114 controls who only smoke cigarettes.

Actemra Designated Breakthrough Therapy for Giant Cell Arteritis

Giant cell arteritis is a chronic, potentially life-threatening autoimmune condition that is more likely to affect women than men.

Antihypertensive Class Linked to Reduced Joint Pain, Opioid Use in Osteoarthritis

Recent evidence suggests that beta-blockers may have anti-nociceptive properties.

FDA: Osteoporosis Treatment No Longer Available

The Food and Drug Administration (FDA) has posted a discontinuation notice for Fortical (calcitonin-salmon [rDNA origin]; Upsher-Smith) Nasal Spray effective September 30, 2016.

New Oral Treatment for Uncontrolled Gout Available

Zurampic is now available for combination use with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone.

NDA Submitted for Spinal Muscular Atrophy Treatment

Biogen and Ionis have completed the rolling submission of a New Drug Application (NDA) to the FDA for the approval of nusinersen, an invesigational treatment for spinal muscular atrophy (SMA), for which there is currently no approved treatment.

Duchenne Muscular Dystrophy Drug Granted Fast Track Status

Summit Therapeutics announced it has received a Fast Track designation from the Food and Drug Administration (FDA) for Ezutromid in the treatment of Duchenne muscular dystrophy (DMD).

Stelara Approved to Treat Crohn's Disease

Janssen Biotech announced that the Food and Drug Administration (FDA) has approved Stelara (ustekinumab) for the treatment of moderately to severely active Crohn's disease in adult patients.

FDA Approves Fourth Biosimilar Drug Amjevita

The Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto; Amgen) as a biosimilar to Humira (adalimumab; AbbVie) for various inflammatory diseases.

BLA Submitted for Investigational RA Drug

Janssen Biotech announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the approval of sirukumab for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

AACE/ACE: New Guidelines for Postmenopausal Osteoporosis Management

The American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) announced the publication of new clinical guidelines and an accompanying algorithm to help physicians and other healthcare professionals with the diagnosis, fracture risk assessment, and treatment of postmenopausal osteoporosis

Propranolol Explored as Possible Tardive Dyskinesia Treatment

A new retrospective study found evidence which suggests that the β-adrenergic blocker propranolol, may be an effective treatment for tardive dyskinesia (TD), for which there are no current approved treatments.

Antihypertensive Drug Class May Impact Fracture Risk in Older Patients

The use of angiotensin receptor blocker (ARBs) in older men with hypertension was associated with a reduced incidence of non-vertebral fracture than angiotensin-converting enzyme (ACE) inhibitors or calcium channel blockers (CCBs), according to a study published in Age and Ageing.

C. Difficile/Oral Bisphosphonate Link Examined Using FDA Reporting System

Compared to other bisphosphonates, alendronate was associated with a higher number of Clostridium difficile infection (CDI) adverse drug reactions, as indicated by the Food and Drug Administration (FDA) Adverse Event Reporting System data (FAERS).

Popular Alternative Therapies Effective for Certain Pain Conditions

The pain conditions included back pain, neck pain, osteoarthritis, fibromyalgia, severe headaches and migraine.

Can Lesinurad Added to Allopurinol Lower Serum Urate in Gout Patients?

Adding lesinurad to allopurinol provided extra benefit vs. allopurinol alone in lower serum urate (sUA) levels and is an option for patients requiring additional urate-lowering, a study published in Arthritis & Rheumatology reported.