Rischin A.,The Alfred Hospital |
Ostor A.J.K.,Cabrini Medical Center
Inflammopharmacology | Year: 2017
Biologic agents have become indispensable in the management of autoimmune disease particularly rheumatological conditions. The lives of countless individuals have been improved following treatment with these drugs. Unfortunately, their cost prohibits more widespread use around the globe. This critical issue has been addressed by the introduction of biosimilars into the market. These therapies have been developed to resemble the originator molecule as closely as possible and to increase competition in the therapy area thus allowing costs to be reduced. Our review is intended to offer an update on biosimilars including logistic considerations on their introduction into routine practice. © 2017, Springer International Publishing.
Kremer J.,Albany Medical College |
Li Z.-G.,Peking University |
Hall S.,Cabrini Medical Center |
Fleischmann R.,Metroplex Clinical Research Center |
And 10 more authors.
Annals of Internal Medicine | Year: 2013
Background: Many patients with rheumatoid arthritis (RA) do not achieve adequate and safe responses with disease-modifying antirheumatic drugs (DMARDs). Tofacitinib is a novel, oral, Janus kinase inhibitor that treats RA. Objective: To evaluate the efficacy and safety of tofacitinib in combination with nonbiologic DMARDs. Design: 1-year, double-blind, randomized trial (ClinicalTrials.gov: NCT00856544). Setting: 114 centers in 19 countries. Patients: 792 patients with active RA despite nonbiologic DMARD therapy. Intervention: Patients were randomly assigned 4:4:1:1 to oral tofacitinib, 5 mg or 10 mg twice daily, or placebo advanced to tofacitinib, 5 mg or 10 mg twice daily. Measurements: Primary end points were 20% improvement in American College of Rheumatology (ACR20) criteria; Disease Activity Score for 28-joint counts based on the erythrocyte sedimentation rate (DAS28-4[ESR]) of less than 2.6; DAS28-4(ESR)- defined remission, change in Health Assessment Questionnaire Disability Index (HAQ-DI) score, and safety assessments. Results: Mean treatment differences for ACR20 response rates (month 6) for the 5-mg and 10-mg tofacitinib groups compared with the combined placebo groups were 21.2% (95% CI, 12.2% to 30.3%; P < 0.001) and 25.8% (CI, 16.8% to 34.8%; P < 0.001), respectively. The HAQ-DI scores (month 3) and DAS28- 4(ESR) less than 2.6 response rates (month 6) were also superior in the tofacitinib groups versus placebo. The incidence rates of serious adverse events for patients receiving 5-mg tofacitinib, 10-mg tofacitinib, or placebo were 6.9, 7.3, or 10.9 events per 100 patientyears of exposure, respectively. In the tofacitinib groups, 2 cases of tuberculosis, 2 cases of other opportunistic infections, 3 cardiovascular events, and 4 deaths occurred. Neutrophil counts decreased, hemoglobin and low- and high-density lipoprotein cholesterol levels increased, and serum creatinine levels had small increases in the tofacitinib groups. Limitations: Placebo groups were smaller and of shorter duration. Patients received primarily methotrexate. The ability to assess drug combinations other than tofacitinib plus methotrexate was limited. Conclusion: Tofacitinib improved disease control in patients with active RA despite treatment with nonbiologic DMARDs, primarily methotrexate. © 2013 American College of Physicians.
Hoy D.,University of Queensland |
Bain C.,University of Queensland |
Williams G.,University of Queensland |
March L.,University of Sydney |
And 5 more authors.
Arthritis and Rheumatism | Year: 2012
Objective To perform a systematic review of the global prevalence of low back pain, and to examine the influence that case definition, prevalence period, and other variables have on prevalence. Methods We conduced a new systematic review of the global prevalence of low back pain that included general population studies published between 1980 and 2009. A total of 165 studies from 54 countries were identified. Of these, 64% had been published since the last comparable review. Results Low back pain was shown to be a major problem throughout the world, with the highest prevalence among female individuals and those aged 40-80 years. After adjusting for methodologic variation, the mean ± SEM point prevalence was estimated to be 11.9 ± 2.0%, and the 1-month prevalence was estimated to be 23.2 ± 2.9%. Conclusion As the population ages, the global number of individuals with low back pain is likely to increase substantially over the coming decades. Investigators are encouraged to adopt recent recommendations for a standard definition of low back pain and to consult a recently developed tool for assessing the risk of bias of prevalence studies. Copyright © 2012 by the American College of Rheumatology.
A randomised, double-blind, parallel-group study of the safety and efficacy of subcutaneous tocilizumab versus intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with moderate to severe rheumatoid arthritis (SUMMACTA study)
Burmester G.R.,Charité - Medical University of Berlin |
Burmester G.R.,Humboldt University of Berlin |
Rubbert-Roth A.,University of Cologne |
Cantagrel A.,Toulouse 1 University Capitole |
And 10 more authors.
Annals of the Rheumatic Diseases | Year: 2014
Objectives This study compared the efficacy and safety of subcutaneous (SC) versus intravenous (IV) formulations of tocilizumab in patients with rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs (DMARD). Methods Patients (n=1262) were randomly assigned to receive tocilizumab-SC 162 mg weekly+placebo-IV every 4 weeks or tocilizumab-IV 8 mg/kg every 4 weeks+placebo-SC weekly in combination with traditional DMARD. The primary outcome was to demonstrate the non-inferiority of tocilizumab-SC to tocilizumab-IV with regard to the proportion of patients in each group achieving an American College of Rheumatology (ACR) 20 response at week 24 using a 12% non-inferiority margin (NIM). Secondary outcomes were disease activity score using 28 joints (DAS28), ACR responses, health assessment questionnaire scores and safety assessments. Results At week 24, 69.4% (95% CI 65.5 to 73.2) of tocilizumab-SC-treated patients versus 73.4% (95% CI 69.6 to 77.1) of tocilizumab-IV-treated patients achieved an ACR20 response (weighted difference between groups -4.0%, 95% CI -9.2 to 1.2); the 12% NIM was met. ACR50/70 responses, DAS28 and physical function improvements were comparable between the tocilizumab- SC and tocilizumab-IV groups. The safety profiles of tocilizumab-SC and tocilizumab-IV were similar, and the most common adverse event was infection. Injection-site reactions (ISR) occurred more frequently in the tocilizumab- SC group than in the tocilizumab-IV (placebo-SC) group. No anaphylaxis was reported over the 24 weeks. Conclusions Tocilizumab-SC 162 mg weekly demonstrated comparable efficacy to tocilizumab-IV 8 mg/kg. The safety profile of tocilizumab-SC is consistent with the known and well-established safety profile of tocilizumab-IV, with the exception of a higher incidence of ISR, which were more common with tocilizumab-SC administration.
News Article | February 10, 2017
The International Association of HealthCare Professionals is pleased to welcome Democleia Panagou Gottesman, MD, Gastroenterologist, to their prestigious organization with her upcoming publication in The Leading Physicians of the World. Dr. Democleia Panagou Gottesman is a highly trained and qualified physician with an extensive expertise in all facets of her work. Dr. Gottesman has been in practice for more than 20 years and is currently serving patients within Star Medical Offices in Brooklyn, New York. She is also affiliated with New York Methodist Hospital and Queens Medical Center. Dr. Gottesman graduated Magna Cum Laude from Tarkio College, prior to completing her Master’s Degree in Biochemistry at the University of Iowa. She then attended Hahnemann University School of Medicine where she graduated with her Medical Degree, before completing her Internal Medicine residency and Gastroenterology fellowship at the Cabrini Medical Center. Dr. Gottesman is double board certified in Internal Medicine and in Gastroenterology, and maintains a professional membership with the American College of Physicians. Dr. Gottesman is dedicated to providing her patients with the highest level of quality and compassionate care. She provides general consultations, disease screenings, colonoscopy, endoscopy, and gastroscopy. Dr. Gottesman also provides treatment to her patients suffering from nausea, constipation, ulcers, hemorrhoids, acid reflux, and stomach pain. She attributes her success to her hard work, and when she is not working, Dr. Gottesman enjoys playing golf and traveling. Learn more about Dr. Gottesman here: http://www.starmedicaloffices.com/ and be sure to read her upcoming publication in The Leading Physicians of the World. FindaTopDoc.com is a hub for all things medicine, featuring detailed descriptions of medical professionals across all areas of expertise, and information on thousands of healthcare topics. Each month, millions of patients use FindaTopDoc to find a doctor nearby and instantly book an appointment online or create a review. FindaTopDoc.com features each doctor’s full professional biography highlighting their achievements, experience, patient reviews and areas of expertise. A leading provider of valuable health information that helps empower patient and doctor alike, FindaTopDoc enables readers to live a happier and healthier life. For more information about FindaTopDoc, visit http://www.findatopdoc.com
De Silva I.M.,Dandenong Hospital |
Teague J.A.,Cabrini Medical Center |
Blake W.E.,Dandenong Hospital |
Blake W.E.,Cabrini Medical Center
Journal of Plastic, Reconstructive and Aesthetic Surgery | Year: 2013
Since 1995, the association between Anaplastic Large Cell Lymphoma (ALCL) and breast implant capsules has been of increasing concern. Up to 40 cases have been reported worldwide. The majority of cases favour an indolent course, similar to that of primary cutaneous ALCL, with a 10-year survival rate of greater than 90%. Many recommendations have been made for diagnosis, treatment and adjuvant therapy but the issue of reconstruction post capsulectomy and removal of implants has not yet been addressed. We present a case report and management option. © 2013 British Association of Plastic, Reconstructive and Aesthetic Surgeons.
Davis G.A.,Cabrini Medical Center |
Davis G.A.,Florey Institute of Neuroscience and Mental Health |
Castellani R.J.,University of Maryland, Baltimore |
McCrory P.,Florey Institute of Neuroscience and Mental Health
Neurosurgery | Year: 2015
The recent interest in concussion in sport has resulted in significant media focus about chronic traumatic encephalopathy (CTE), although a direct causative link(s) between concussion and CTE is not established. Typically, sport-related CTE occurs in a retired athlete with or without a history of concussion(s) who presents with a constellation of cognitive, mood, and/or behavioral symptoms and who has postmortem findings of tau deposition within the brain. There are many confounding variables, however, that can account for brain tau deposition, including genetic mutations, drugs, normal aging, environmental factors, postmortem brain processing, and toxins. To understand the roles of such factors in neurodegenerative diseases that may occur in athletes, this article reviews some neurodegenerative diseases that may present with similar findings in nonathletes. The article also reviews pathological changes identified with normal aging, and reviews the pathological findings of CTE in light of all these factors. While many of these athletes have a history of exposure to head impacts as a part of contact sport, there is insufficient evidence to establish causation between sports concussion and CTE. It is likely that many of the cases with neuropathological findings represent the normal aging process, the effects of opiate abuse, or a variant of frontotemporal lobar degeneration. Whether particular genetic causes may place athletes at greater risk of neurodegenerative disease is yet to be determined.. Copyright © 2015 by the Congress of Neurological Surgeons.
Makdissi M.,Florey Institute of Neuroscience and Mental Health |
Makdissi M.,University of Melbourne |
Davis G.,Florey Institute of Neuroscience and Mental Health |
Davis G.,Cabrini Medical Center |
And 6 more authors.
British Journal of Sports Medicine | Year: 2013
Background One of the key difficulties while managing concussion in sport is that there are few prognostic factors to reliably predict clinical outcome. The aims of the current paper are to review the evidence for concussion modifiers and to consider how the evaluation and management of concussion may differ in specific groups. Methods A qualitative review of the literature on concussion was conducted with a focus on prognostic factors and specific groups including children, female athletes and elite versus non-elite players. PubMed, MEDLINE and SportsDiscus databases were reviewed. Results The literature demonstrates that number and severity of symptoms and previous concussions are associated with prolonged recovery and/or increased risk of complications. Brief loss of consciousness (LOC) and/or impact seizures do not reliably predict outcomes following a concussion, although a cautious approach should be adopted in an athlete with prolonged LOC or impact seizures (ie, >1 min). Children generally take longer to recover from concussions and assessment batteries have yet to be validated in the younger age group. Currently, there are insufficient data on the influence of genetics and gender on outcomes following a concussion. Conclusions Several modifiers are associated with prolonged recovery or increased risk of complications following a concussion and have important implications for management. Children with concussion should be managed conservatively, with an emphasis on return to learn as well as return to sport. In cases of concussions managed with limited resources (eg, non-elite players), a conservative approach should also be taken. There should be an emphasis on concussion education in all sports and at all levels, particularly in junior and community-based competitions.
Buchbinder R.,Cabrini Medical Center |
Richards B.,University of Sydney |
Harris I.,University of New South Wales
Current Opinion in Rheumatology | Year: 2014
PURPOSE OF REVIEW: Over the last decade, there has been increased recognition of the importance of high-quality randomized controlled trials in determining the role of surgery for knee osteoarthritis. This review highlights key findings from the best available studies, and considers whether or not this knowledge has resulted in better evidence-based care. RECENT FINDINGS: Use of arthroscopy to treat knee osteoarthritis has not declined despite strong evidence-based recommendations that do not sanction its use. A large randomized controlled trial has demonstrated that arthroscopic partial meniscectomy followed by a standardized physical therapy program results in similar improvements in pain and function at 6 and 12 months in comparison to physical therapy alone in patients with knee osteoarthritis and a symptomatic meniscal tear, confirming the findings of two previous trials. Two recent randomized controlled trials have demonstrated that decision aids help people to reach better-informed decisions about total knee arthroplasty. A majority of studies have indicated that for people with obesity the positive results of total knee arthroplasty may be compromised by postoperative complications, particularly infection. SUMMARY: More efforts are needed to overcome significant evidence-practice gaps in the surgical management of knee osteoarthritis, particularly arthroscopy. Decision aids are a promising tool. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.
News Article | November 18, 2016
Marvell Scott, M.D., Discusses Treatment of Professional Athletes Using Injections That Do Not Have the Risks Associated with Steroids, Opioids, or NSAIDs. Marvell Scott, M.D., conducted a webinar about alternative pain relief treatments on October 12, 2016, which was watched by doctors from coast to coast. The event is now available to watch online HERE In the webinar, Dr. Scott discusses how he treats several musculoskeletal conditions including orthopedic surgery recovery, tennis elbow, tendonitis, tendinopathy, partial tears, post-surgical and post-traumatic arthrofibrosis, sports injuries, musculoskeletal pain, and osteoarthritis. Dr. Scott’s practice includes a wide range of patients, from some of the greatest athletes in the world to older patients dealing with high levels of disability due to intractable pain. Dr. Scott began his practice exclusively using a wide range of conventional drugs like glucocorticoid injections, but has since broadened his range of medications to include the use of natural medications, where they have proven to be effective. Today MediNatura™ injections and topical medicines are a mainstay of the alternative side of Dr. Scott’s practice. “In my practice, we have seen that the risks with Traumeel®, Zeel®, and other MediNatura™ injections are minimal in comparison with traditional glucocorticoid injections, but the benefits for pain relief are comparable,” said Dr. Scott. Many of his patients have endured exhaustive attempts to alleviate their pain through conventional treatment options, including multiple cortisone injections. “Cortisone is your synthetic version of cortisol, which is your aging hormone, so there are a lot of limitations with frequency and dosage,” said Dr. Scott. “With MediNatura™ products like Traumeel®, Zeel®, Neuralgo-Rheum®, and other injections I am able to inject a much broader spectrum of areas without weakening the tendon or suppressing the immune system.” “I treat well over 100 patients a week. Twenty to thirty injections a day, sometimes seven days a week. This may be tens of thousands of injections, and I haven’t had any real adverse reactions,” said Dr. Scott. In the webinar, Dr. Scott mentions that his professional athlete clients needed reassurance that Traumeel® and Zeel® contain no performance-enhancing drugs (PEDs). To address this concern, Dr. Scott independently hired a prestigious U.S. laboratory to conduct testing, which confirmed that the treatments are free of banned substances, including PEDs. Additionally, Traumeel® and Zeel® have never caused an issue with the random drug screening tests conducted on professional athletes. Dr. Scott completed his internal medicine residency at Mount Sinai School of Medicine’s sister hospital Cabrini Medical Center. He did his sports medicine specialty fellowship at UMDNJ-Robert Wood Johnson Medical School, where he worked with Rutgers and Princeton’s 30 varsity sports teams. Almost eight years ago, while working in northern Italy with the EuroLeague (a professional basketball league) and with the international soccer team A.C. Milan, he was introduced to the MediNatura™ products. He also learned that the doctors who treat the German Olympic team, German national soccer team, and multiple professional soccer teams such as Real Madrid and Bayern Munich, were successfully using Traumeel®. MediNatura™ Inc., a Delaware Corporation headquartered in greater Philadelphia, specializes in prescription and over the counter pharmaceuticals made from natural medicines. You can reach MediNatura™ toll-free at 1-844-633-4628 Monday through Friday from 8 a.m. to 5 p.m. MST or visit MediNatura.com MediNatura™ imports Traumeel®, Zeel®, and other injections from Germany, where they are manufactured in FDA-audited factories according to strict U.S. pharmaceutical standards for purity and sterility. Full prescribing information for Traumeel® is available at CLICK HERE and for Zeel® at CLICK HERE.