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.

FDA Approves First Biosimilar to Enbrel

The Food and Drug Administration (FDA) has approved Erelzi (etanercept-szzs; Sandoz) injection, a biosimilar to Enbrel (etanercept; Amgen).

Glucocorticoid Inj Permanently Discontinued

The Food and Drug Administration (FDA) is informing about the permanent discontinuation of Aristospan (triamcinolone hexacetonide injectable suspension; Sandoz).

Methotrexate Monotherapy, Combo Therapy Compared for RA

Researchers from the University of Calgary found moderate to high quality evidence that triple therapy with methotrexate + sulfasalazine + hydroxycholoroquine or combining methotrexate + most biologic disease-modifying antirheumatic drug (DMARDs) or tofacitinib demonstrated similar efficacy in controlling disease activity in methotrexate-naive patients or after an inadequate response to methotrexate.

Drug Therapies Compared for Glucocorticoid-Induced Osteoporosis

Amgen announced top-line data from a primary analysis conducted in a Phase 3 study evaluating the safety and efficacy of Prolia (denosumab) vs. risedronate in patients receiving glucocorticoid treatment.

Myopathy: Another Side Effect of PPIs?

Limited research published in Annals of Pharmacotherapy suggests that use of proton pump inhibitors (PPI) is associated with myopathy-like symptoms without long-term effects after discontinuation.

Ultrasonography Assessed as Drug Guiding Modification for Arthritis

Ultrasonography can be useful for guiding modification of anti-rheumatic drugs and steroids for patients with inflammatory arthritis (IA), according to a study published online in the International Journal of Rheumatic Diseases.

Synacthen Depot Fast-Tracked for Duchenne Muscular Dystrophy

Mallinckrodt announced that the FDA has granted Fast Track designation to the Investigational New Drug (IND) application of Synacthen Depot (tetracosactide) for the treatment of Duchenne muscular dystrophy (DMD).

Use of Drugs Linked with Fracture Risk Evaluated Post-Fracture

Exposure to prescription drugs associated with fracture risk was not consistently reduced after a fragility fracture occurrence, researchers reported in a JAMA Internal Medicine article.

FDA Designates Dusquetide Orphan Drug for Life-Threatening Immune Disorder

The FDA has granted Orphan Drug designation to dusquetide (SGX942; Soligenix) for the treatment of macrophage activation syndrome (MAS), a life-threatening complication of rheumatic disease.

Experimental Drug Reduces Fracture Risk Better than Existing Therapy in Osteoporosis Study

In postmenopausal women with osteoporosis, an experimental drug appears to reduce the risk of bone fractures better than teriparatide or a placebo, according to a study published in the Journal of the American Medical Association.

Investigational Muscle Protein Designated Orphan Drug for DMD

The FDA has granted Orphan Drug designation to TVN-102 (Tivorsan), previously referred to as recombinant human Biglycan, for the treatment of Duchenne Muscular Dystrophy (DMD).

DASH Diet May Benefit Gout Patients

A study published in Arthritis & Rheumatology has found that the DASH diet reduced serum uric acid, particularly in patients with hyperuricemia.

Gout Flares With Arhalofenate Vs Allopurinol Examined in Study

Arhalofenate (800mg) is safe and significantly decreases gout flares compared to allopurinol (300mg), according to a study published online July 27 in Arthritis & Rheumatology.

Thymectomy Tied to Multiple Benefits in Myasthenia Gravis

Thymectomy improves clinical outcomes over a three-year period in patients with nonthymomatous myasthenia gravis, according to research published in the Aug. 11 issue of the New England Journal of Medicine.

FDA Grants Priority Review to Deflazacort for Duchenne Muscular Dystrophy

The FDA has accepted for filing and granted Priority Review to the New Drug Applications (NDA) of deflazacort immediate-release tablet and oral suspension formulations for the treatment of Duchenne Muscular Dystrophy (DMD).

FDA Approves Updated ONJ Warning for Prolia, Xgeva

The Food and Drug Administration (FDA) has approved supplemental Biologics License Applications (sBLA) for Amgen's Prolia (denosumab) and Xgeva (denosumab).

Gelsyn-3 Now Available for Knee Osteoarthritis Pain

Bioventus announced the availability of Gelsyn-3 (hyaluronic acid), an injectable indicated for pain associated with osteoarthritis of the knee.

Hand, Hip, and Knee Osteoarthritis Risks Increase in Tandem With Weight

The incidence of hand, hip, and knee osteoarthritis (OA) increases with overweight and obesity, particularly in the knee, according to a study published in Arthritis & Rheumatology.

Ustekinumab Significantly Improves Patient-Reported Outcomes in PsA

Significant improvements in patient-reported outcomes (PROs) were seen with ustekinumab vs. placebo in 3 antecedent-exposure populations of patients with psoriatic arthritis, including those with prior methotrexate and anti-tumor-necrosis factor (TNF) use, according to findings from a study published in Arthritis Care & Research.

Interchangeability of Biosimilar and Reference TNF-α Inhibitors Examined

Preliminary data from a systematic review supported the biosimilarity and interchangeability of biosimilar and reference tumor necrosis factor alpha (TNF-α) inhibitors.

Dysport Approved for Pediatric Lower Limb Spasticity

Ipsen announced that the FDA has approved the supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA) for injection for the treatment of lower limb spasticity in patients aged ≥2 years. This approval marks Dysport as the first FDA-approved botulinum toxin for this indication.

Gout Management Updates Reflect New Treatments

The European League Against Rheumatism (EULAR) have updated their recommendations on the management of gout to reflect novel treatments and evidence surrounding already established treatments.

Analysis Identifies Uveitis Risk Factors in Ankylosing Spondylitis Patients

An analysis published in Medicine identified hip-joint lesion, prevalence of peripheral arthritis, and antistreptolysin O (ASO) and circulating immune complex (CIC) levels as risk factors that may be tied to higher rates of uveitis in ankylosing spondylitis.

Study Examines Efficacy of Ultrasound-Guided Treatment for Trigger Finger

An ultrasonographically (US)-guided percutaneous treatment using a 21-gauge needle is efficacious for trigger finger, according to a study published in the August issue of Radiology.

FDA to Review Investigational Bone-Forming Monoclonal Antibody for Osteoporosis

Amgen and UCB announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Lab-Grown Cartilage Moves Closer to Being Hip Replacement Option

Progress has been made toward developing lab-grown cartilage that could postpone or possibly eliminate the need for hip replacement surgery in younger arthritis patients, according to research published online in the Proceedings of the National Academy of Sciences.

RA Drug Available in New Autoinjector Device

Bristol-Myers Squibb announced the launch of Orencia (abatacept) ClickJect Autoinjector, a new autoinjector for adults with moderate to severe rheumatoid arthritis.

Aleve Direct Therapy Device Available OTC for Lower Back Pain

Bayer announced the launch of Aleve Direct Therapy, a drug-free, pain relief device.

Vagus Nerve Stimulation May Help Ease RA Symptoms

Electronic stimulation of the vagus nerve may help ease symptoms of rheumatoid arthritis (RA), according to a study published online in the Proceedings of the National Academy of Sciences.

Risky Whole Body Cryotherapy Growing in Popularity

The Food and Drug Administration (FDA) is warning against misleading claims about whole body cryotherapy to treat various diseases or conditions.

CDC: Arthritis Prevalence May Rise To 78.4 Million By 2040

The prevalence of arthritis and arthritis-attributable activity limitation is projected to increase in U.S. adults by 2040, according to a study published online in Arthritis & Rheumatology.

DPP-4 Inhibitors Linked to Improved Vitamin D Balance in T2DM Patients

Findings from a study published in Acta Diabetologica support that treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors is associated with better vitamin D balance in patients with type 2 diabetes.

Do TNF Inhibitors Offer CV Benefits in Psoriasis, Psoriatic Arthritis?

In a study published in Clinical Reviews in Allergy & Immunology, researchers found that tumor necrosis factor (TNF inhibitors appeared to have clinical benefits with regard to adverse cardiovascular events in psoriasis and/or psoriatic arthritis.

Study Sheds Light on Link Between Immunotherapy and Arthritis Onset

A new study has shed light on an association between immune checkpoint inhibitors (ICIs) and the onset of inflammatory arthritis and sicca syndrome.

Hypertension, Pain Combo Drug Shown Beneficial on Kidney Function

Kitov Pharmaceuticals announced new study data from the Phase 3 study for KIT-302 (amlodipine besylate/celecoxib) in the treatment of osteoarthritis pain and hypertension, suggesting beneficial effects on renal function.

Does Prior TNFi Use Affect Secukinumab Effectiveness in Psoriatic Arthritis?

Secukinumab, a human anti-IL-17A monoclonal antibody, was shown to be effective in both tumor necrosis factor inhibitor (TNFi)-naïve and TNFi-exposed psoriatic arthritis patients, however greater improvements were noted in TNFi- naïve patients.

Higher Allopurinol Dose May be Nephroprotective in Elderly

A higher allopurinol dose provided a protective effect against incident renal failure in elderly patients, according to a study published in Annals of the Rheumatic Diseases.

Tocilizumab vs. Methotrexate Compared in Newly Diagnosed RA Patients

Immediate initiation with tocilizumab with or without methotrexate was more effective than methotrexate alone for patients with newly diagnosed rheumatoid arthritis, researchers concluded in a study published in The Lancet.

FDA to Review Deflazacort for Duchenne Muscular Dystrophy

Marathon Pharmaceuticals announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for deflazacort for the treatment of patients with Duchenne Muscular Dystrophy (DMD).