Infusion Reactions with Krystexxa: New Phase 3 Results Announced

Crealta announced results from two Phase 3 trials and one open-label extension trial on loss of urate-lowering response to Krystexxa (pegloticase) and risk of infusion reactions cited in the product's Food and Drug Administration (FDA)-approved labeling.

Baricitinib Demonstrates Efficacy in Rheumatoid Arthritis

Eli Lilly and Company and Incyte Corp. announced results from the Phase 3 RA-BEACON study of baricitinib in patients with active rheumatoid arthritis (RA).

Experimental Drug May Help Spinal Cord Injury

A new drug could allow the long axons of spinal cord nerve cells to regenerate after paralyzing spinal cord injuries, unlike current treatments that may require touching the healing spinal cord.

40% of Seniors Report Disability, Census Report Shows

According to a U.S. Census Bureau report, almost 40% of people ages ≥65 had at least one disability, of which two-thirds reported difficulty in walking or climbing.

Dysport sBLA Under Review for Upper Limb Spasticity

The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA; Ipsen) for the treatment of upper limb spasticity in adults.

New Clinical Guidelines Issued for Paget's Disease

The Endocrine Society released a Clinical Practice Guideline for the diagnosis and treatment of Paget's disease of the bone.

Duchenne Muscular Dystrophy Therapy Designated Orphan Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CAT-1004 (Catabasis) for the treatment of Duchenne Muscular Dystrophy (DMD).

Hidden NSAIDs Found in Herbal Supplement

The Food and Drug Administration (FDA) is warning consumers not to buy or use "Feng Shi Ling," a product marketed as an herbal drug for pain due to rheumatoid arthritis and osteoporosis.

Otezla Demonstrates Sustained Response in Active Psoriatic Arthritis

Celgene announced results from two PALACE Phase 3 clinical trials with Otezla (apremilast) for the treatment of adults with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Secukinumab Demonstrates Efficacy in Psoriatic Arthritis Trials

Novartis announced results from the Phase 3 FUTURE 1 and FUTURE 2 studies with secukinumab in patients with psoriatic arthritis (PsA).

Combination Therapy Effective in Rheumatoid Arthritis Study

Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase 3b AVERT trial investigating the use of Orencia (abatacept) plus methotrexate (MTX) in biologic and MTX-naïve CCP-positive early moderate to severe rheumatoid arthritis (RA) patients.

Men Rarely Screened for Osteoporosis, Study Suggests

Men are three times less likely to undergo bone mass density (BMD) testing following a distal radial fracture compared to women, reports a new study.

Xiaflex Gains Expanded Dupuytren's Contracture Use

Auxilium announced that the Food and Drug Administration (FDA) has approved Xiaflex (collagenase clostridium histolyticum) for the treatment of up to 2 Dupuytren's contracture joints in the same hand during a single treatment visit.

Rasuvo Autoinjector Launched for RA, pJIA, Psoriasis

Medac Pharma announced the launch of Rasuvo (methotrexate) injection for patients with rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis (pJIA), and psoriasis.

FDA Expands Humira Use for pJIA in Children Aged 2 Years and Up

AbbVie announced that the Food and Drug Administration (FDA) has approved the use of Humira (adalimumab) for moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) to reducing signs and symptoms in patients aged ≥2 years.

Humira Gains Pediatric Crohn's Disease Indication

AbbVie announced that the Food and Drug Administration (FDA) has approved Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease for patients ≥6 years old.

Minivelle Patch Gains New Strength, New Indication

Noven announced that the Food and Drug Administration (FDA) has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis.

Otezla Tabs Gain New Psoriasis Indication

Celgene announced that the Food and Drug Administration (FDA) has approved Otezla (apremilast) for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

Orthopedists Release Choosing Wisely Recommendations

The American Orthopaedic Foot & Ankle Society (AOFAS) has released a list of tests and procedures that are commonly ordered but not always necessary.

Odanacatib Reduces Fracture Risk in Postmenopausal Women

Merck announced results from the Phase 3 LOFT study with odanacatib in postmenopausal women with osteoporosis.

Updated Phase 3 Efficacy Results for Ampio

Ampio announced an update to the Phase 3 multicenter, double-blind STEP study of Ampion for osteoarthritis (OA) of the knee.

Zorvolex Gains New Pain Indication

Iroko announced that the Food and Drug Administration (FDA) has approved Zorvolex (diclofenac) capsules for the management of osteoarthritis pain.

Ryanodex FDA-Approved To Treat Inherited Life-Threatening Condition

Eagle Pharmaceuticals announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension, an antidote for the management of malignant hyperthermia (MH), along with the appropriate supportive measures.

Mislabeling Causes Ibuprofen, Oxcarbazepine Recall

American Health Packaging announced a voluntary recall of Ibuprofen Tablets 600mg and Oxcarbazepine Tables 300mg due to mislabeled inner unit dose blister packaging.

FDA Approves Rasuvo Injection for RA, JIA, Psoriasis

Medac Pharma announced that the FDA has approved Rasuvo (methotrexate) subcutaneous auto-injector for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis.

Contact-Free Vital Signs Monitoring Device Gets FDA Clearance

EarlySense has announced that the FDA has issued clearance for the Chair Sensor Solution, the first automatic contact-free sensor for continuous monitoring of patients' vital signs in a chair.

First Wearable, Motorized Exoskeleton for Paraplegics Cleared by FDA

The FDA has cleared the first motorized device intended to act as an exoskeleton in individuals with paraplegia due to spinal cord injuries for use at home and in the community.

Biomarkers May Predict Long-Term Outcomes in JIA

At EULAR 2014, scientists presented the possibility of using biomarkers to predict disease outcomes at 12 months in children with juvenile idiopathic arthritis (JIA).

Higher Cost Burden Seen With Musculoskeletal Disorders vs. Others

Increased healthcare costs were associated with musculoskeletal disorders compared to other disease states, according to a new study presented at EULAR 2014.

Can Genotyping Determine RA Outcomes?

Positions 11, 71, and 74 of the HLA-DRB1 gene was shown to be strong independent genetic determinants of radiological damage in rheumatoid arthritis (RA).

Biomarkers in RA Patients Linked to Anti-TNF Treatment Response

A potential biomarker of response to anti-TNF therapies in patients with rheumatoid arthritis (RA) has been identified, which could lead to the personalization of RA treatment.

Erectile Dysfunction Often Present in Men with Gout

Erectile dysfunction (ED) is present and frequently severe in most men with gout, reports research presented at the European League Against Rheumatism Annual Congress (EULAR 2014).

Cranial Ultrasound More Sensitive in GCA Diagnosis

Cranial ultrasound is superior in sensitivity and has comparable specificity in the diagnosis of giant cell arteritis (GCA) compared to temporal artery biopsy (TAB), according to a new study.

Monounsaturated Fatty Acids May Suppress RA Activity

At EULAR 2014, two studies shed insight on the relationship between dietary intake of monounsaturated fatty acids and cholesterol with disease activity in rheumatoid arthritis (RA) and osteoarthritis (OA), respectively.

CT-P13 Comparable to Infliximab in Ankylosing Spondylitis Tx

CT-P13, an infliximab biosimilar, achieved statistically similar improvements in disease activity disability, and mobility in patients with ankylosing spondylitis (AS) compared to infliximab, results from the PLANETAS study found at EULAR 2014.

Romosozumab Significantly Increases Bone Mineral Density, Content

Romosozumab was found to significantly increase bone mineral density and bone content in the spine and hip in postmenopausal women compared to baseline and also compared to teriparatide and placebo, as presented at EULAR 2014.

Many Not Receiving Optimal TNF-Alpha Inhibitor Dose in Psoriatic Arthritis

Many patients with psoriatic arthritis were not receiving doses of TNFα inhibitor, adalimumab, to obtain optimal clinical benefit, according to data presented at EULAR 2014.

Saline as Effective as PRP Injections in Epicondylitis Pain

At EULAR 2014, new research showed that ultrasound-guided injections of growth factors-containing platelet-rich plasma (PRP) are no more effective than saline injection sin treating recently developed epicondylitis.

Are BMI and RA Outcomes Inversely Linked?

Obese patients with rheumatoid arthritis (RA) have higher disease activity scores (DAS) than non-obese patients, regardless of their disease stage, scientists presented at EULAR 2014.

MicroRNAs May Help Predict Osteoarthritis

Recent findings identify a correlation between the presence of biomarkers in the blood (micro RNAs [miRNAs]) and the development of severe osteoarthritis of the knee or hip joint, as presented at EULAR 2014.

Stopping Immunosuppressants without Flare Trigger in Lupus Patients

New research showed that it is possible to successfully stop immunosuppressant therapy without triggering a flare for the majority of lupus patients in remission, as presented at EULAR 2014.

Improved Penile Curvature Deformity with Xiaflex

Auxilium Pharmaceuticals announced new data from its Phase 3 IMPRESS trials that evaluated Xiaflex for the treatment of Peyronie's disease at the 2014 Annual Meeting of the AUA.

First-of-Kind Prosthetic Arm Approved by FDA

DEKA Integrated Solutions has received FDA marketing approval for the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrode in individuals with upper extremity amputations occurring at the shoulder joint, mid-upper arm, or mid-lower arm.

Arthritis Supplement Contains 3 Hidden Ingredients

Nano Well-Being Health is issuing a voluntary recall of two lots of Super Arthgold 500mg capsules, a dietary supplement for joint pain and arthritis.

FDA: Corticosteroid Injections Need Label Warning

The FDA is warning patients and healthcare professionals about the potential for rare but serious adverse events associated with injection of corticosteroids into the epidural space of the spine.

Eteplirsen NDA Submission Plans for Rare Neuromuscular Disorder

Sarepta Therapeutics has announced its plans to submit a New Drug Application (NDA) for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

Otrexup Results Published for Rhuematoid Arthritis

Antares Pharma announced the publication of results from its crossover study comparing the relative bioavailability, safety, and tolerability of Otrexup (methotrexate) to oral methotrexate (MTX) in adults with rheumatoid arthritis in the Annals of the Rheumatic Diseases.

First Oral Psoriatic Arthritis Drug Launched in Specialty Pharmacies

ReCept announced that it is one of the specialty pharmacies selected to distribute Otezla (apremilast; Celgene), a recently approved drug for adults with active psoriatic arthritis.

Results Reinforce Ampion Use in OAK

Ampio announced results of the 20 weeks extension of the SPRING study of Ampion for the treatment of osteoarthritis of the knee (OAK).

Paralyzed Patients Move Muscles with Spinal Stimulation

A novel therapy that involves electrical stimulation of the spinal cord has resulted in four individuals with paraplegia now being able to voluntarily move previously paralyzed muscles

New Oral Tablets Approved for Psoriatic Arthritis

The FDA has approved Otezla (apremilast; Celgene) tablets for the treatment of adults with active psoriatic arthritis.

Blood Transfusions for Spinal Fusion Holding Steady

Among U.S. patients undergoing spinal fusion, the rates of allogeneic blood transfusion increased from 2000-2009, while predonated autologous blood transfusion rates decreased.

Priority Review Granted for Malignant Hyperthermia Drug

Eagle Pharmaceuticals announced that the FDA has accepted the NDA for Ryanodex (dantrolene sodium) and has granted a priority review classification for the treatment of malignant hyperthermia.

Same-Day Double Knee Replacement Safe With RA

Same-day bilateral total knee arthroplasty (BTKA) is safe in rheumatoid arthritis (RA) patients.

Training Young Athletes Could Prevent ACL Injury

Neuromuscular training of all young athletes is a cost-effective strategy for reducing the costs and morbidity associated with ACL injuries.

Increase in Extreme Sport Head, Neck Injuries

The incidence of head and neck injuries (HNIs) resulting from participation in extreme sports increased from 2000-2011.

Risk Factors ID'd for Post-Knee Replacement Pain

For patients undergoing primary total knee replacement, surgical, radiographic, and demographic variables associated with postoperative pain have been identified in two studies.

Repeat Spine Imaging Frequent With Injured Patient Transfers

There is a substantially high rate of repeat spine imaging when patients with known spinal injuries are transferred from an outside hospital to a tertiary receiving institution.

Longer Massage Sessions Effective for Neck Pain

Multiple 60-minute massage sessions are effective for neck dysfunction and pain among patients with chronic neck pain.

Glucosamine for Knee Cartilage Studied

Oral glucosamine supplementation is not associated with a decrease in knee cartilage deterioration among individuals with chronic knee pain.

Pain Supplement Recall Due to Hidden Ingredients

Pain Free By Nature announced a recall of Reumofan Plus Tablets because they were found to contain the following undeclared active ingredients: methocarbamol and diclofenac.

Challenges Ahead for Artificial Hip, Knee Services

An estimated 4.5 million people are living with an artificial hip, and 6.7 million people in the United States are currently living with an artificial knee.

Knee, Hip Arthroplasty Provides Cardiovascular Benefit

Receipt of a primary elective knee or hip total joint arthroplasty (TJA) for osteoarthritis (OA) provides a cardiovascular protective benefit.

Evaluating Total Hip Arthroplasty in Nonagenarians

Nonagenarian patients can safely undergo a total hip arthroplasty (THA), according to a recent study.

More Lumbar Sx Complications at Certain Hospitals

Patients undergoing lumbar spine surgery at teaching hospitals incur longer hospitalizations and have more postoperative complications compared to those treated at nonteaching hospitals.

Extended-Release Drug for Chronic Low Back Pain Meets Endpoint

Purdue Pharma announced results from a Phase 3 study of an extended-release formulation of hydrocodone bitartrate in patients with chronic low back pain.

Internal Opioid System Predicts NSAID Tx Response for Neuropathic Pain

Scientists can predict who will respond to NSAID treatment by assessing the nervous system's own capacity to regulate pain

Pre-Op Pain Patterns Affect Stenosis Surgery Outcomes

For patients with spinal stenosis without degenerative spondylolisthesis, predominance of back pain versus leg pain is associated with worse surgical outcomes

Marijuana Not Recommended for Rheumatic Conditions

Health care professionals should currently discourage rheumatology patients from using herbal cannabis as a therapy.

Single-Patient Trials Determine Statin Tolerability

In patients with statin-related myalgia, single-patient randomized trials of statin and placebo can determine whether the myalgia is actually due to the statin.

Catastrophizing Can Predict Low Back Pain, Disability

For patients treated for low back pain, catastrophizing may predict the degree of pain and disability.

Vitamin D Tied to Markers of Inflammation in Elderly

There is a significant association between low vitamin D status and markers of inflammation in elderly adults.

Spinal Study Outcomes, Levels of Evidence Tied to Funding

Source of funding for spinal research is significantly associated with study outcome and level of evidence.

Cigarette Smoke Exposure Affects Bone Mineral Density

Exposure to cigarette smoke (passive or active) is associated with lower bone mineral density (BMD) in the femoral neck and lumbar spine of men.

Regional Anesthesia Doesn't Up Falls After Knee Replacement

Regional anesthesia, including peripheral nerve block (PNB), does not increase the risk of inpatient falls (IFs) after total knee arthroplasty (TKA).

First Non-Animal HA Inj for Knee Osteoarthritis Approved

Anika Therapeutics received FDA marketing approval for Monovisc (sodium hyaluronate [NaHA] in phosphate buffered saline) for the treatment of osteoarthritis (OA) of the knee.

Fever During Pregnancy Associated With Birth Defects

Fever during pregnancy is associated with adverse health outcomes for the offspring.

Xeljanz Label Gains Radiographic Data Addition

Pfizer announced that the FDA has approved a sNDA to update the current label of Xeljanz (tofacitinib citrate) tablets to include radiographic data from two Phase 3 studies, ORAL Scan and ORAL Start.

FDA Accepts sBLA for Xiaflex for Concurrent Treatment of Multiple Palpable Cords

The FDA has accepted Auxilium's supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren's contracture (DC) cords concurrently.

Psychological Factors Affect Skeletal Trauma Recovery

For patients recovering from musculoskeletal trauma, psychological factors, especially catastrophic thinking, are associated with pain intensity and disability.

Surgeons Can Up Outcomes for Work-Related Lumbar Surgery

In chronic disabling occupational lumbar disorder (CDOLD), lumbar fusion outcomes can be improved if opioid dependence and excessive length of disability after surgery are controlled through care.

Obesity Complicates Elbow Fractures in Children

Obesity is associated with more complex supracondylar humeral fractures in children, as well as with a greater risk of postoperative complications.

Home Exercise Program Boosts Physical Function After Rehab

For older patients, a home-based exercise program is beneficial after formal hip fracture rehabilitation has ended,

Compression Device Noninferior to Meds Post-Arthroplasty

For patients undergoing lower-extremity arthroplasty, a mobile compression device is noninferior to pharmacological protocols for the prevention of venous thromboembolism.

New Treatment for Rare Congenital Enzyme Disorder

The FDA announced the approval of Vimizim (elosulfase alfa; BioMarin) for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome).

More Walking, Brisk Walking Lower Hip Fx Risk in Older Men

For older men, walking is associated with reduced risk of hip fracture, with more walking and brisker walking correlating with greater risk reduction.

Predictors of Post-Op Pain ID'd in Adolescent Idiopathic Scoliosis

Higher preoperative levels of pain and anxiety may be risk factors for chronic postsurgical pain for patients with adolescent idiopathic scoliosis (AIS) undergoing posterior spinal fusion.

30-Day Readmission From Postacute Rehab 11.8%

For patients discharged from inpatient rehabilitation facilities, 30-day readmission rates are 11.8% overall.

Pennsaid 2% Solution Now Available

Pennsaid (diclofenac sodium; Mallinckrodt) topical solution 2% w/w is now available.

Diabetes Does Not Worsen Outcomes of Cervical Laminoplasty

Patients with or without diabetes experienced similar outcomes of laminoplasty for cervical spondylotic myelopathy.

MRI Patterns in Disc Prolapse, Degenerative Disease Described

Patients with back pain and degenerative disc disease (DDD) have different patterns of lumbar disc degeneration than patients with disc prolapse (DP).

First Diagnostic Criteria for TMJ Published

Researchers have developed the first evidence-based diagnostic criteria for temporomandibular disorders (TMD).

Model Can Predict Spine Surgery Complications

A new model can predict the risk of medical complications, including major complications, after spine surgery.

Marital History, Support Linked to Bone Health

Marital history, including disruptions and age at marriage, is associated with bone health in men, while marital support correlates with bone health in women.

Low BMI Tied to Better Surgical Scoliosis Curve Correction

For patients undergoing spinal fusion for adolescent idiopathic scoliosis (AIS), low body mass index (BMI) is associated with greater percent correction of thoracic curves.

FDA to Review MPI-2505 NDA for RA, Psoriasis

Medac Pharma announced that the FDA has accepted for review its New Drug Application (NDA) for its lead product candidate MPI-2505 (methotrexate).

Hormone Therapy Linked to Arthroplasty Revision

Hormone replacement therapy use (HRT) is associated with a reduction in revision rates for total knee arthroplasty (TKA) and total hip arthroplasty (THA).

Total Knee Arthroplasty Has Economic Benefit for Society

The total economic cost to society for treatment of severe knee osteoarthritis is considerably lower with total knee arthroplasty than with nonoperative treatment.

Wait Time to Lumbar Discectomy Linked to Post-Op Pain

The likelihood of experiencing worse pain at six months post-surgery is increased with a waiting time of 12 weeks or more for elective surgical lumbar discectomy (ESLD).

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