Untrimmed Toenails: A Marker of Functional Status in Older Patients?

For older patients, toenail length can provide important insight into a patient's functional status.

Top-Line Results Announced for Investigational RA Treatment Upadacitinib

At week 12, results showed 71% in the upadacitinib group had achieved ACR20, compared to 63% and 36% in the adalimumab and placebo groups, respectively.

Elamipretide Granted Orphan Drug Status for Barth Syndrome

The TAZPOWER study is a randomized, double-blind, placebo-controlled Phase 2/3 crossover study evaluating the safety and efficacy of elamipretide (daily subcutaneous injections) in 12 male patients (aged ≥12 years) with genetically-confirmed Barth syndrome.

First-in-Class Inhibitor Designated Orphan Drug for Spinal Muscular Atrophy

By inhibiting the activation of myostatin, SRK-015 may promote a clinically meaningful increase in muscle mass and strength.

Many Patients Receive Inappropriate Tests, Treatments for Low Back Pain

More emphasis should be placed on self-management, physical and psychological therapies for treating low back pain, rather than pharmacological or surgical treatments.

Cimzia Label Update Provides New Information for Women of Childbearing Age

Data added to the labeling includes first-of-their-kind pharmacokinetic studies demonstrating negligible to low transfer of CIMZIA through placenta and minimal transfer to breast milk from mother to infant.

Abaloparatide Followed by Alendronate Ups BMD in Postmenopausal Women

At the 43-month endpoint, a total of 60.7% (307/506) of the abaloparatide followed by alendronate group had ≥3% increase in bone mass at all 3 sites (P<0.0001) vs. 24% (121/505) of the placebo followed by alendronate group.

Durolane Now Available to Treat Knee Osteoarthritis Pain

In clinical trials, treatment with Durolane resulted in greater reduction in Visual Analog Scale (VAS) pain scores at 3 and 6 months compared to Synvisc One (hylan G-F 20; Sanofi Genzyme) (P<0.001).

Does Hydroxychloroquine Improve Symptoms of Hand Osteoarthritis?

Findings do not support the current practice of off-label use of hydroxychloroquine for treating symptomatic hand osteoarthritis.

Positive Results for Ixekizumab in the Treatment of Ankylosing Spondylitis

Taltz demonstrated a statistically significant improvement in the signs and symptoms of AS.

ACR Issues New Position Statement on the Use of Biosimilars

Healthcare providers should incorporate biosimilars, where appropriate, into their regimens to treat patients with rheumatic diseases.

Does Long-Term ICS Use Increase Fracture Risk in COPD Patients?

Long-term ICS exposure at high doses was associated with a modest but significant increase in the risk of hip or upper extremity fractures.

Medical Food Used for Managing Osteoarthritis Recalled at FDA's Request

There have been no deaths reported with the use of Limbrel.

Trans-Capsaicin Injection Gets Fast Track Status for Knee OA Pain

CNTX-4975 works by targeting the capsaicin receptor (TRPV1) to selectively and rapidly inactivate the local pain fibers transmitting signals to the brain.

Do Vitamin D, Calcium Supplements Cut Fracture Risk in Older Patients?

Thirty-three randomized trials (n=51,145) were identified that met the inclusion criteria.

FDA Approves New Indication for Xeljanz, Xeljanz XR

The new PsA approval was based on data from the Phase 3 OPAL Broaden, OPAL Beyond, and OPAL Balance studies.

Biosimilar Ixifi Gets FDA Approval for All Remicade Indications

Ixifi is a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor.

RAS Inhibitor Use May Cut Risk of MI in Rheumatoid Arthritis Patients

The use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) was associated with a reduced risk of myocardial infarction (MI) among patients with rheumatoid arthritis (RA).

Taltz Approved for the Treatment of Active Psoriatic Arthritis

Taltz may be administered alone or in combination with a conventional disease-modifying antirheumatic drug, such as methotrexate.

Certain Drug Classes Tied to Less Frequent Driving Impairment Warnings

More than two-thirds (85%) of those on sedatives and narcotics reported being counseled by a provider on the possibility of impaired driving.

Steroid Injection Site Linked to Bone Changes in Osteoarthritis Patients

Their results found that 22-24% of the hip injection group had new osteonecrosis vs. 5-9% of the hip control group and to 5% of the shoulder injection group.

Hemophilic Arthropathy Treatment Gets Orphan Drug Designation

TRM-201 (rofecoxib) is a highly potent COX-2 selective non-steroidal anti-inflammatory drug (NSAID) with a well-established efficacy profile.

FDA: Potentially Life-Threatening Adverse Events Linked to Limbrel

The FDA is continuing to investigate Primus Pharmaceuticals and the manufacturing process for Limbrel, and will share updates as they become available.

Does Treating Undifferentiated Arthritis Delay RA Development?

The primary outcome was development of rheumatoid arthritis.

Cervical Dystonia Drug Candidate Gets Orphan Drug Designation

Treatments for cervical dystonia include oral medications, botulinum toxin injections, surgery, and complementary therapies.

Zilretta Now Available for the Management of Osteoarthritis Knee Pain

Zilretta is the first extended-release, intra-articular injection for OA knee pain.

Enbrel Mini With AutoTouch Now Available

The needle stays hidden during injection and a sensor can detect placement on skin. It also includes 3 difference injection speeds, a progress bar and a speaker.

New Drug-Free Therapy Available for Arthritis Pain

The device has 14 pre-set therapy modes designed to block acute or chronic pain or to imitate exercise recovery, endurance and muscle strength.

FDA: Gout Drug Linked to Increased Risk of Heart-Related Death

The FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009.

Anti-Inflammatory Foods May Help With RA Symptoms, Progression

Specific foods that were highlighted include dried plums, blueberries, pomegranates, whole grains, ginger, turmeric, specific oils, and teas; these foods were found to reduce inflammatory cytokines, joint stiffness, pain, and oxidative stress.

Disease-Modifying Osteoarthritis Tx Granted Fast Track Status

There are currently no DMOADs approved for use in OA. MIV-711 is a selective inhibitor of cathepsin K, which is the principal protease involved in breaking down collagen in bones and cartilage.

Simponi Aria Approved for Psoriatic Arthritis, Ankylosing Spondylitis

The FDA's expanded approvals were supported by data from two Phase 3 multicenter, randomized, double-blind, placebo-controlled studies (GO-VIBRANT and GO-ALIVE) that included >600 patients.

Discontinuation Rates Examined After Switch to Biosimilar

Study authors aimed to assess the pharmacokinetics, efficacy, immunogenicity, safety, and drug discontinuation after switching from infliximab (Remicade) to the biosimilar CT-P13 in 192 patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis in daily practice.

Stelara Approved to Treat Adolescent Patients With Plaque Psoriasis

The expanded approval was supported by data from a Phase 3 study that evaluated the safety and efficacy of subcutaneous Stelara in adolescents aged ≥12 years.

Duzallo Now Available for the Treatment of Uncontrolled Gout

The fixed-dose product combines lesinurad, a uric acid transporter 1 (URAT1) inhibitor, with allopurinol, a xanthine oxidase inhibitor in one tablet.

Zilretta Approved to Treat Osteoarthritis Knee Pain

Phase 3 results found that Zilretta achieved statistically significant reductions on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) sections for pain, stiffness and function compared to immediate-release TCA.

CombiPatch, Minivelle Patches No Longer in Shortage

Noven announced that CombiPatch (estradiol/norethindrone acetate transdermal system) and Minivelle (estradiol transdermal system) are now readily available following a temporary product shortage.

Uloric Dosing Updated to Include Patients with Severe Renal Impairment

The new labeling now recommends patients with severe renal impairment be limited to a dose of 40mg once daily.

FDA: More Data Needed for Sirukumab for Active RA

The CRL indicated a request for additional clinical data in order to evaluate the safety of sirukumab in the treatment of RA.

UTI Treatment Gains Qualified Infectious Disease Product Designation

"We expect to begin enrolling patients as early as December in a proof-of-concept Phase 2 study of omadacycline in uUTI, and an indication in this type of infection would broaden the opportunities for oral omadacycline in community-acquired infections," said Evan Loh, MD, COO and CMO of Paratek.

Long-Term Effectiveness of Adalimumab Examined in RA

The authors reported that of the patients who continued taking adalimumab for ≥1 year, 67.0% were considered in low disease activity (LDA)/remission (CDAI ≥10).

Romosozumab Followed by Alendronate Superior in Reducing Fracture Risk

ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) was a multicenter, international, randomized, double-blind, alendronate-controlled study (n=4,093) in postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.

Fracture Risk Reduced with Abaloparatide Followed by Alendronate

The data showed a statistically significant fracture risk reduction through 3.5 years.

Durolane Approved to Treat Knee Osteoarthritis Pain

In clinical trials, treatment with Durolane effectively relieved pain and restored function for up to six months in patients with knee osteoarthritis.

Limiting Sedentary Time 'Necessary' to Avoid Mobility Loss

At the study's end, 29% of participants were either unable to walk or had difficulty doing so.

FDA Reveals Stem Cell Policy Plans Amid Clinic Crackdowns

An FDA inspection of the clinic found that adipose tissue was being processed into stromal vascular fraction (stem cells derived from body fat) which was then administered intravenously or directly into the spinal cord of patients.

Biosimilar Cyltezo Gets FDA Approval for Multiple Indications

This marks the second approval of a biosimilar for adalimumab.

Fixed-Dose Combo Tx Duzallo Approved for Uncontrolled Gout

This fixed-dose combination product combines lesinurad, a uric acid transporter 1 (URAT1) inhibitor, with allopurinol, a xanthine oxidase inhibitor in one tablet.

Psoriatic Arthritis Treatment Trends Investigated

Researchers used claims data between 2004-2015 from a large commercial database to identify patients with psoriatic arthritis who were initiated on DMARDs.

Are OTC Lidocaine Patches as Effective as Rx for Localized Pain?

Study authors sought to compare OTC lidocaine 3.6% with menthol 1.25% patches vs. Rx lidocaine 5% as well as to placebo.

Osteoporosis Drugs Assessed for Secondary Fracture Prevention

Results showed a significant reduction in the risk for secondary vertebral fracture with all of the of anti-osteoporotic drugs (risk ratio [RR] 0.38-0.77).

FDA Panel Recommends Approval of Tofacitinib for Psoriatic Arthritis

The supplemental New Drug Applications (sNDAs) contained data from Phase 3 trials involving patients with psoriatic arthritis, including safety analyses from the larger tofacitinib clinical development program.

FDA Clears Non-Invasive Device to Treat Chronic Intractable Pain

The Stimpod NMS460 includes a nerve-mapping pen-like probe which allows practitioners to locate nerves and evaluate the treatment progress.

FDA Committee Votes Against RA Drug Candidate Approval

Sirukumab, a human monoclonal IgG1 kappa antibody, works differently than current IL-6 inhibitors approved to treat RA by targeting the IL-6 cytokine vs. the IL-6 receptor.

Xatmep Now Available for Pediatric ALL, pJIA

Methotrexate works by inhibiting dihydrofolic acid reductase, which interferes with DNA synthesis, repair, and cellular replication.

Mislabeled Muscle Spasm, Parkinson's Drugs Prompt Recall

Accidental dosing with Cyclobenzaprine HCl may potentially lead to life-threatening serotonin syndrome when the drug is taken in combination with selective serotonin reuptake inhibitors.

Septic Arthritis Outbreak Highlights Need for Better Infection Prevention in Outpatient Settings

Recovered organisms included various Streptococcus, Actinomyces, Haemophilus, Neisseria species, among others; all of the pathogens isolated were oral flora. Two patients also exhibited Staphylococcus aureus bacteria in the blood.

Biosimilar Renflexis Now Available

Infliximab products work by neutralizing the biological activity of TNF-alpha by binding with high affinity to the soluble and transmembrane forms of TNF-alpha and inhibiting the binding of TNF-alpha with its receptors.

FDA Requests More Data for Unique Osteoporosis Drug Candidate

Dr. Pascale Richetta, head of bone and executive vice president, UCB, stated, "With all three pivotal romosozumab Phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures."

Octagam 10% Gains Orphan Drug Status for Rare Muscle, Skin Disorder

Octagam 10% is currently approved to treat chronic immune thrombocytopenic purpura (ITP) in adult patients. It is supplied as 2g, 5g, 10g, or 20g single-use bottles.

Alendronate May Lower Hip Fracture Risk for Patients on Oral Glucocorticoids

Results showed that after a mean follow-up of 1.32 years, there were 27 hip fractures in the alendronate group and 73 in the non-alendronate group; this corresponded to incident rates of 9.5 (95% CI, 6.5-13.9) and 27.2 (95% CI, 21.6-34.2) fractures per 1000 person-years, respectively.

Orencia Approved to Treat Active Psoriatic Arthritis

A greater response to Orencia was observed in the trial regardless of prior anti-TNF treatment and other non-biologic DMARD therapy.

Is Radiofrequency Denervation Effective for Chronic Low Back Pain?

Results showed a statistically significantly, but not a clinically important, improvement in two of the trials which evaluated radiofrequency denervation for the sacroiliac joints (−0.71 (95% CI, −1.35 to −0.06) and a combination of the facet joints, sacroiliac joints or intervertebral disks (−0.99 (95% CI, −1.73 to −0.25) at 3 months.

Rituxan Biosimilar BLA Accepted for FDA Review

The proposed indications are for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.

Early ART Start Linked to Bone Loss in HIV Patients

Over the 2.2 years mean follow-up, the immediate ART arm demonstrated greater BMD declines vs. the deferred ART arm at the hip (-2.5% vs. -1.0%, 95% CI: -2.2 to -0.8; P<0.001) and at the spine (-1.9% vs. -0.4%, 95% CI: -2.2 to -1.0; P<0.001).

Intensive Use of Hand-Held Devices May Up Carpal Tunnel Risk

The researchers found that intensive electronics users had significantly more discomfort, and more severe discomfort, in their wrist and hand.

Upadacitinib Meets Endpoints for Phase 3 Study in RA

The results from the 12-week period show that both arms of upadacitinib treatment were superior in achieving ACR 20 (64% in 15mg arm, 66% in 30mg arm) vs. placebo (36%).

Opioid Use Patterns Among RA Patients Examined

The authors concluded that "rheumatologists and other clinicians caring for patients with RA face a significant dilemma precisely because the options for care of pain remain problematic."

FDA Expands Dysport Use for Lower Limb Spasticity in Adults

The FDA approval was based on data from a Phase 3, multi-center, prospective, double-blind, randomized, placebo-controlled study in 381 adults treated with Dysport 1000 Units, Dysport 1500 Units or placebo after a stroke or traumatic brain injury.

First-in-Class Drug Candidate Fast Tracked for Chronic Pain

Currently, there is a global Phase 3 program comprised of 6 studies involving approximately 7,000 patients with OA, CLBP or cancer pain with inadequate treatment of pain with approved therapies.

Pooled Safety Analysis Finds Jardiance Well Tolerated

The proportion of study patients with lower limb amputations were similar for Jardiance (1.9%) and placebo groups (1.8%).

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.

Fast Track Status Granted to Tideglusib for Myotonic Dystrophy

In preclinical studies, AMO-02 has shown efficacy in transgenic models and reversal of muscle cell differentiation deficits in ex vivo tissue samples.

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