Stryker Endoscopy Selects MedShare as Recipient of Surplus Medical Equipment Donations

Stryker Endoscopy Selects MedShare as Recipient of Surplus Medical Equipment Donations

Leading medical technology company partners with nonprofit to give medical equipment a second life.

Stryker Endoscopy, a division of Stryker Corporation, one of the world’s leading medical technology companies, named MedShare their chosen partner for donating surplus medical equipment. This relationship will give these useable items a second life in developing countries.

Stryker’s relationship with MedShare, an Atlanta-based nonprofit that recovers medical supplies from hospitals and manufacturers and sends them to underserved healthcare facilities in developing countries, is part of their Corporate Social Responsibility initiative to provide life-enhancing products and work with healthcare providers in innovative ways that help them restore health to their patients and advance sustainable change to improve the quality of patient care. Stryker’s selection of MedShare was based on the nonprofit’s commitment to quality, as well as the credibility they have earned with global partners.

“Stryker Endoscopy is proud to partner with MedShare and we look forward to working together to make a positive impact on healthcare, the environment, and families around the world.”, said Mark Lipscomb, Vice President of HR for Stryker Endoscopy.

The organization will donate a wide variety of equipment and consumables to MedShare, including arthroscopy, laparoscopy, urology and sports medicine surgical tools. Stryker employees will also assess and repair all items prior to donation, an effort in line with MedShare’s commitment to ensure all equipment sent to recipient hospitals is immediately useable upon arrival.

“We are honored that Stryker has selected MedShare to responsibly recover and redistribute their surplus medical equipment,” said Meridith Rentz, CEO of MedShare. “These items are greatly-needed in countries around the world, and strategic partnerships such as this are what enable us to make a difference and improve healthcare systems.”

MedShare is an innovative nonprofit with a dual mission to deliver surplus medical supplies to underserved populations around the world while lessening the impact of medical waste in the U.S. The organization has delivered 700 40-foot containers of humanitarian aid to health facilities in 88 developing countries.

About MedShare
MedShare is a US 501(c)3 organization that bridges the gap between surplus and need to improve healthcare and the environment through the efficient recovery and redistribution of surplus medical supplies and equipment to those most in need. For more information, please visit the organization’s website at www.medshare.org.

About Stryker Corporation
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies including reconstructive implants, medical and surgical equipment, and neurotechnology and spine products to help people lead more active and more satisfying lives. For more information about Stryker, please visit www.stryker.com.

About Stryker Endoscopy
Stryker Endoscopy is a division of the Stryker Corporation, one of the world’s leading medical technology companies. Stryker Endoscopy offers an extensive minimally invasive product portfolio including arthroscopic, laparoscopic, urologic, gynecologic and visualization platforms. For more information about Stryker Endoscopy, visit:www.stryker.com/endoscopy.

2 Responses

  1. on November 21, 2011 at 8:05 pm medical equipment

    sounds amazing!

    nowadays it is indeed important for developing countries to have their own equipment so that they would be able to provide the necessary services to their people. thanks for the great post!

  2. on December 13, 2011 at 6:50 pm Peter Egan

    How would I go about donating used or returned medical equipment items to those in need?

Comments are closed.

Nanoscale Films Developed At MIT Promote Bone Growth, Creating A Stronger Seal Between Implants And Patients’ Own Bone.

Main Category: Bones / Orthopedics
Also Included In: Arthritis / Rheumatology;  Medical Devices / Diagnostics
Article Date: 23 Apr 2012 – 0:00 PDT

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Every year, more than a million Americans receive an artificial hip or knee prosthesis. Such implants are designed to last many years, but in about 17 percent of patients who receive a total joint replacement, the implant eventually loosens and has to be replaced early, which can cause dangerous complications for elderly patients.

To help minimize these burdensome operations, a team of MIT chemical engineers has developed a new coating for implants that could help them better adhere to the patient’s bone, preventing premature failure.

“This would allow the implant to last much longer, to its natural lifetime, with lower risk of failure or infection,” says Paula Hammond, the David H. Koch Professor in Engineering at MIT and senior author of a paper on the work appearing in the journal Advanced Materials.

The coating, which induces the body’s own cells to produce bone that fixes the implant in place, could also be used to help heal fractures and to improve dental implants, according to Hammond and lead author Nisarg Shah, a graduate student in Hammond’s lab.


An alternative to bone cement

Artificial hips consist of a metal ball on a stem, connecting the pelvis and femur. The ball rotates within a plastic cup attached to the inside of the hip socket. Similarly, artificial knees consist of plates and a stem that enable movement of the femur and tibia. To secure the implant, surgeons use bone cement, a polymer that resembles glass when hardened. In some cases, this cement ends up cracking and the implant detaches from the bone, causing chronic pain and loss of mobility for the patient.

“Typically, in such a case, the implant is removed and replaced, which causes tremendous secondary tissue loss in the patient that wouldn’t have happened if the implant hadn’t failed,” Shah says. “Our idea is to prevent failure by coating these implants with materials that can induce native bone that is generated within the body. That bone grows into the implant and helps fix it in place.”

The new coating consists of a very thin film, ranging from 100 nanometers to one micron, composed of layers of materials that help promote rapid bone growth. One of the materials, hydroxyapatite, is a natural component of bone, made of calcium and phosphate. This material attracts mesenchymal stem cells from the bone marrow and provides an interface for the formation of new bone. The other layer releases a growth factor that stimulates mesenchymal stem cells to transform into bone-producing cells called osteoblasts.

Once the osteoblasts form, they start producing new bone to fill in the spaces surrounding the implant, securing it to the existing bone and eliminating the need for bone cement. Having healthy tissue in that space creates a stronger bond and greatly reduces the risk of bacterial infection around the implant.

“When bone cement is used, dead space is created between the existing bone and implant stem, where there are no blood vessels. If bacteria colonize this space they would keep proliferating, as the immune system is unable to reach and destroy them. Such a coating would be helpful in preventing that from occurring,” Shah says.

It takes at least two or three weeks for the bone to fill in and completely stabilize the implant, but a patient would still be able to walk and do physical therapy during this time, according to the researchers.

Tunable control

There have been previous efforts to coat orthopedic implants with hydroxyapatite, but the films end up being quite thick and unstable, and tend to break away from the implant, Shah says. Other researchers have experimented with injecting the growth factor or depositing it directly on the implant, but most of it ends up draining away from the implant site, leaving too little behind to have any effect.

The MIT team can control the thickness of its film and the amount of growth factor released by using a method called layer-by-layer assembly, in which the desired components are laid down one layer at a time until the desired thickness and drug composition are achieved.

“This is a significant advantage because other systems so far have really not been able to control the amount of growth factor that you need. A lot of devices typically must use quantities that may be orders of magnitude more than you need, which can lead to unwanted side effects,” Shah says.

The researchers are now performing animal studies that have shown promising results: The coatings lead to rapid bone formation, locking the implants in place.

This coating could be used not only for joint replacements, but also for fixation plates and screws used to set bone fractures. “It is very versatile. You can apply it to any geometry and have uniform coating all around,” Shah says.

Another possible application is in dental implants. Conventionally, implanting an artificial tooth is a two-step process. First, a threaded screw is embedded in the jaw; this screw has to stabilize by integrating with the surrounding bone tissue for several months before the patient returns to the clinic to have the new crown attached to the screw. This could be reduced to a one-step process in which the patient receives the entire implant using a version of these coatings.

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‘Reforming Medicare In The Age Of Deficit Reduction’

Main Category: Medicare / Medicaid / SCHIP
Article Date: 23 Apr 2012 – 1:00 PDT

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American College of Physicians says stakeholders across health care spectrum must work together to protect Medicare for future generations.

A dozen recommendations to ensure that Medicare beneficiaries have access to high-quality, coordinated care were provided today by the American College of Physicians (ACP). The new policy paper, ‘Reforming Medicare in the Age of Deficit Reduction’ *[PDF], was released at Internal Medicine 2012, ACP’s annual scientific meeting.

“This position paper considers the potential advantages and disadvantages of proposals to reform Medicare in an attempt to quell rising Medicare/health care costs. Options such as transforming Medicare into a premium support program, increasing the Medicare eligibility age, and applying income-based Medicare premiums are discussed.” Virginia L. Hood, MBBS, MPH, MACP, president of ACP said “We have long supported efforts to ensure that Medicare beneficiaries have access to affordable, high quality, coordinated care, so want to have evidence that a revised system would meet these criteria.”

The Medicare program is a defined benefit, where enrollees receive guaranteed financial contributions for a package of health benefits. Some proposals to reform the Medicare system would transform the Medicare program to a defined contribution (or premium support) program, where beneficiaries would receive a finite amount of financial assistance to purchase health insurance.

“Too little is known today about the impact of a Medicare premium support on patient access to care for a risky decision to be made to transition away from the current guaranteed benefit structure,” cautioned Dr. Hood. “Rather than rushing a decision, we propose testing a premium support program on demonstration project basis, with strong protections to ensure that costs are not shifted to enrollees to the extent that it hinders their access to care. Until we have reassuring data from pilots, ACP can’t support adoption of this model, just as physicians would not recommend a new treatment to our patients without data from clinical trials on potential benefits and harms.”

ACP also commented on proposals to advance the age when persons would be eligible for Medicare from age 65 to age 67, suggesting that this could open up a “coverage gap” unless alternative programs to provide coverage for people who would have to wait two years longer to become eligible for Medicare. For instance, Congress could give people between the ages of 55 and 67 the option of buying into Medicare.

“As an alternative to proposals to shift costs to beneficiaries, many of whom cannot afford to pay more, Medicare should adopt policies to reform payment and delivery systems that get at the true drivers of rising Medicare costs,” continued Dr. Hood.

ACP specifically offered these recommendations for ensuring Medicare’s solvency, reducing costs, and maintaining access to affordable care for beneficiaries:

  • The Medicare program must lead a paradigm shift in the nation’s health care system by testing and accelerating adoption of new care models that improve population health, enhance the patient experience, and reduce per-beneficiary cost.
  • To improve the way health care is delivered and ensure the future of primary care, the College recommends that Medicare accelerate adoption of the patient centered medical home model and provide severity-adjusted monthly bundled care coordination payments, prospective payments per eligible patient, fee-for-service payments for visits, and performance assessment-based payments tied to quality, patient satisfaction and efficiency measures.
  • ACP does not support conversion of the existing Medicare defined benefits program to a premium support model. However, ACP could support pilot-testing of a defined benefit premium support option, on a demonstration project basis, with strong protections to ensure that costs are not shifted to enrollees to the extent that it hinders their access to care.
  • ACP supports policies to ensure that Medicare Advantage plans are funded at the level of the traditional Medicare program.
  • The Medicare eligibility age should only be increased to correspond with the Social Security eligibility age if affordable, comprehensive insurance is made available to those made ineligible for Medicare.
  • ACP supports continuing to gradually increase Medicare premiums for wealthier beneficiaries as well as modest increases in the payroll tax to fund the Medicare program.
  • Congress should consider giving Medicare authority to redesign benefits, coverage and cost sharing to include consideration of the value of the care being provided.
  • ACP supports combining Medicare Parts A and B with a single deductible under specified circumstances.
  • Supplemental Medicare coverage – Medigap plans – should only be altered in a manner that encourages use of high quality, evidence-based care and does not lead Medicare beneficiaries to reduce use of such care because of cost.
  • Medicare should provide for palliative and hospice services, including pain relief, patient and family counseling, and other psychosocial services for patients living with terminal illness.
  • The costs of the Medicare Part D prescription drug program should be reduced by the federal government acting as a prudent purchaser of prescription drugs.
  • Congress should amend the authority for an Independent Payment Advisory Board in specified ways, including giving Congress the right to approve or disapprove the board’s recommendations by a simple majority.

“Many of the reforms proposed by members of Congress and the various deficit reduction commissions would either directly or indirectly increase the financial burden for which Medicare beneficiaries are responsible,” Dr. Hood concluded. “Increasing cost-sharing responsibilities on Medicare beneficiaries – many of whom are retired and must survive on a fixed income – may encourage more cautious use of services but not necessarily those that are most appropriate for their health. Also, there is no guarantee that such changes will slow the nation’s rising health care costs, which are driven by technological advancements, growth in prices for health care services, and a number of other factors. ACP is concerned that any Medicare reform efforts must ensure a balance between maintaining access to medically necessary care and reducing wasteful and limited value care.”

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Researchers Find Joint Failures Potentially Linked To Oral Bacteria

Main Category: Arthritis / Rheumatology
Also Included In: Bones / Orthopedics;  Dentistry
Article Date: 20 Apr 2012 – 0:00 PDT

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The culprit behind a failed hip or knee replacements might be found in the mouth. DNA testing of bacteria from the fluid that lubricates hip and knee joints had bacteria with the same DNA as the plaque from patients with gum disease and in need of a joint replacement.

This study is one of many coming from the Case Western Reserve University School of Dental Medicine that have linked oral bacteria to health problems when they escape from the mouth and enter the blood.

Working with University Hospitals Case Medical Center researchers, the dental, orthopedic and arthritis researchers suggest it might be the reason why aseptic loosening or prosthetic wear of the artificial joints fail within 10 years when no infection appears to be present. The pilot study’s findings were reported in the April issue of the Journal of Clinical Rheumatology.

Dr. Nabil Bissada, chair of the Department of Periodontics at the dental school, said the objective of the study, “Identification of Oral Bacterial DNA in Synovial Fluid of Patients with Arthritis with Native and Failed Prosthetic Joints,” was to see if bacteria like Fusobacterium nucleatum and Serratia proteamaculans found in patients with gum disease were present in the fluid.

“For a long time, we’ve suspected that these bacteria were causing problems in arthritis patients, but never had the scientific evidence to support it,” Bissada says.

The researchers recruited and studied 36 patients seeking care at the University Hospitals Case Medical Center for osteoarthritis (the wearing of the joints) and rheumatoid arthritis (an autoimmune disease).

These study participants had both natural and artificial joints. Researcher extracted samples of their synovial fluid, which is much like oil that keeps a door from squeaking. These patients also had signs of periodontitis or gum disease and undergone exams where dental plaque was obtained for the study.

Plaque build-up from the bacteria, associated with gum disease, breaks down the walls of the pockets around the teeth. The inflammation process from the bacteria acts like a gate that gives bacteria access to the blood stream. Once in the blood, the oral bacteria have induced inflammation in remote sites where the bacteria has been linked to heart, kidney and cancer diseases and premature births and fetal deaths.

Because these bacteria cannot be found with routine lab tests, detection of bacteria in the plaque and fluid was done through a process called polymerase chain reactions and DNA sequence analysis of specific genes (16S-23S rRNA). This is a sophisticated DNA tracking procedure.

Five of the 36 patients (14%) showed direct DNA links between the bacteria in the fluid and plaque from the mouth. The breakdown in patients was: one from a rheumatoid arthritis (RA) patient with a failed natural joint and one RA patient with a failed replacement joint; two osteoarthritis (OA) patients with failed artificial joints and one OA patient with a failed natural joint.

Bissada said researchers will continue exploring the oral health link in a larger study. “We have a link now and want to see just how much of a trend this is. We also will be able to see if treating the periodontal disease, can reduce the number of future costly joint replacements.”

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Surgical Procedures For Skin Cancer Via Medicare Examined

Editor’s Choice
Main Category: Melanoma / Skin Cancer
Also Included In: Medicare / Medicaid / SCHIP;  Cancer / Oncology
Article Date: 19 Apr 2012 – 9:00 PDT

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According to an evaluation of Medicare beneficiaries, there has been a significant increase in surgical treatment for nonmelanoma skin cancer (NMSC), from 2001 until 2006. The study, published in the April issue of Archives of Dermatology, states that the increase is primarily due to a doubling in the rate of Mohs micrographic surgery procedures.

According to background information in the study, each year, over 3 million NMSCs are diagnosed in the U.S. Treatment options vary from surgical excision to Mohs micrographic surgery (MMS), which involves examining 100% of the surgical margin during the procedure.

Whilst most primary basal cell carcinomas surgical excision proves effective, cure rates are higher with MMS in patients with recurrent, infiltrative and high-risk anatomical site cancers. For instance, on the face. The researchers point out that there is a debate as to which option, i.e. MMS or surgical excision, is more effective for primary NMSC, as well as MMSs cost-efficacy.

Kate V. Viola, M.D., M.H.S., of the Albert Einstein College of Medicine in New York, and her team performed a retrospective evaluation of a 5% sample of Medicare beneficiaries that consisted of a total of 26,931 patients, of which 9,802 patients or 36.4% had MMS and 17,129 patients or 63.6% had surgical excisions to treat NMSC, between 2001 until 2006.

They noted that the rate of MMS doubled from 0.75 to 1.5, per 100 Medicare beneficiaries, during the study period, whilst the rate for surgical excisions only rose marginally from 1.8 to 2.1 per 100 Medicare beneficiaries. They noted that patients had a 60.1% higher chance of receiving MMS if their lesions were on the lip, and 57.2% if it was on the eyelid, compared with 39.9% of surgical excisions on the lip, and 42.8% on the eyelid.

The researchers note that the highest percentage of NMSC patients who were treated with MMS was in Atlanta (45.1%), and that the majority of patients who received MMS were younger patients.

They conclude:

“To our knowledge, this is the only study to examine the national patterns of use of MMS for NMSC over time. Patient age and lesion location were significantly associated with the type of surgery (MMS vs. surgical excision), yet there were wide variations in regional MMS use and geographical disparity that warrant further investigation. Additional large, prospective studies are needed to further identify surgical treatment outcomes for NMSC.”

Written By Petra Rattue

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

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” Mohs Micrographic Surgery and Surgical Excision for Nonmelanoma Skin Cancer Treatment in the Medicare Population”
Kate V. Viola, MD, MHS; Mamta B. Jhaveri, MD, MS; Pamela R. Soulos, MPH; Ryan B. Turner, MD; Whitney L. Tolpinrud, MD; Daven Doshi, MD; and Cary P. Gross, MD, MPH
Archives of Dermatology, April 2012, doi:10.1001/archdermatol.2011.2456

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Women At Greater Risk Of Knee Injuries

Main Category: Arthritis / Rheumatology
Also Included In: Sports Medicine / Fitness;  Women’s Health / Gynecology
Article Date: 19 Apr 2012 – 1:00 PDT

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Women are more prone to knee injuries than men, and the findings of a new study suggest this may involve more than just differences in muscular and skeletal structure – it shows that males and females also differ in the way they transmit the nerve impulses that control muscle force.

Scientists at Oregon State University found that men control nerve impulses similar to individuals trained for explosive muscle usage – like those of a sprinter – while the nerve impulses of women are more similar to those of an endurance-trained athlete, like a distance runner.

In particular, the research may help to explain why women tend to suffer ruptures more often than men in the anterior cruciate ligament of their knees during non-contact activities. These ACL injuries are fairly common, can be debilitating, and even when repaired can lead to osteoarthritis later in life.

More study of these differences in nervous system processing may lead to improved types of training that individuals could use to help address this issue, scientists said.

“It’s clear that women move differently than men, but it’s not as obvious why that is,” said Sam Johnson, a clinical assistant professor in the OSU School of Biological and Population Health Sciences.

“There are some muscular and skeletal differences between men and women, but that doesn’t explain differences in injury rates as much as you might think,” Johnson said. “No one has really studied the role of the nervous system the way we have in explaining these differences, specifically the way sensory information is processed and integrated with motor function in the spinal cord.”

In this study, just published in the European Journal of Applied Physiology, the scientists found that most aspects of spinal motor control and rapid activation of muscles were similar in 17 men and 17 women that were examined – with one exception. Men had a higher level of “recurrent inhibition,” which is a process in the spinal cord that helps select the appropriate muscle response.

Even a process as simple as walking is surprisingly complicated, as people process large amounts of information and use varying forces to move around obstacles, change direction or simply climb up a step. And when you slip on an icy patch, the need for extremely rapid and accurate muscle response might be all that stands between you and a broken hip.

For some reason, women tend to have knee motions that make them more susceptible to injury. Among other things, when landing from a jump their knees tend to collapse inward more than that of most men. They suffer significantly more ACL injuries during physical activity.

“We’re finding differences in nervous system processing that we believe are related to this,” Johnson said. “The causes for those differences are unclear, but it may be due either to a biological difference, such as hormones, or a cultural difference such as different exercise and training patterns.”

This research was supported by the National Athletic Trainers’ Association Research and Education Foundation. Researchers at Marquette University collaborated on the work.

While researchers continue to study what might help address this, Johnson said it’s already possible for women to be more aware of these common differences and do exercises that should reduce problems.

Many ACL injury prevention programs incorporate strength, balance, flexibility, and jump training. However, based on these and other findings, women – especially athletes – should consider training with motions more similar to those of their sport, such as squatting, lunging, jumping or cutting side-to-side.

Use of heavy weights may not really be necessary, Johnson said, so much as mimicking the motions that often cause this injury.

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During Medicare Coverage Gaps, Patients Often Stop Taking Heart Drugs

Main Category: Compliance
Also Included In: Heart Disease;  Medicare / Medicaid / SCHIP
Article Date: 19 Apr 2012 – 0:00 PDT

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Patients who paid for heart medications solely through Medicare were 57 percent more likely to not take them during coverage gaps compared to those who had a Part D low-income subsidy or additional insurance, according to research published in Circulation: Cardiovascular Quality and Outcomes, an American Heart Association journal.

Neither group was more likely to switch to other drugs during coverage gaps.

“Rather than prompting patients to switch to lower-cost alternatives, we found that sudden exposure to 100 percent of drug costs in the Part D coverage gap led to abrupt discontinuation of essential cardiovascular medications,” said Jennifer M. Polinski, Sc.D., M.P.H., study lead author and instructor in medicine at Harvard Medical School in Boston, Mass. “Any drug insurance policy that negatively influences essential cardiovascular drug use needs to be changed.”

Heart and blood vessel, or cardiovascular disease, is the leading cause of death in the United States. The risk of disease increases with age, but complications often can be prevented with medication and lifestyle changes.

During the study, the Medicare prescription drug benefit, known as Part D, stopped paying for medicine when spending reached a certain amount. Payments resumed when patients’ out-of-pocket expenses reached qualifying levels or the benefit restarted in the next calendar year, but long-term effects of the coverage gap, or “donut hole,” on drug compliance and health are unclear.

Patients who did not receive financial assistance during the coverage gap were no more likely to die or be hospitalized for cardiovascular-related conditions than those who did have financial assistance – contrasting with previous research results that looked at the impact of lapses in drug coverage in other, non-Part D settings. The difference could be due to the current study’s relatively short follow-up of 119 days, the typical amount of time patients spent in the coverage gap, said Polinski, who is also an epidemiologist at Brigham and Women’s Hospital and an instructor in epidemiology at the Harvard School of Public Health. The coverage gap’s impact on cardiovascular health outcomes in the long-term remains unclear.

The initial study group comprised 122,255 heart disease patients who reached the Medicare Part D coverage gap in either 2006 or 2007. Researchers then compared drug termination rates between 3,980 Medicare beneficiaries without supplemental insurance to an equal number with additional coverage.

Participants were predominately white, and nearly half were 65 to 74 years old and female. Most had high blood pressure and about one-third had heart failure. Both of these conditions can be fatal without proper medical and prescription drug treatment.

Study limitations include the relatively short follow-up, the small number of hospitalizations and deaths observed, and the observational design that can’t control for all possible influences.

Recent reforms include provisions in the Affordable Care Act that will help close the coverage gap over time. As of January 1, 2011, Medicare beneficiaries receive a 50 percent discount on brand name drugs and a 7 percent discount on generic drugs while in the coverage gap. The size of the discount increases over time until the coverage gap is eliminated in 2020. However, efforts to repeal or strike down the Affordable Care Act, if successful, would eliminate these discounts for Medicare beneficiaries, reinstating the coverage gap and once again requiring them to pay all drug costs during the coverage gap.

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Cimzia Trial Shows Promise For Axial Spondyloarthritis And Ankylosing Spondylitis

Editor’s Choice
Main Category: Arthritis / Rheumatology
Also Included In: Clinical Trials / Drug Trials
Article Date: 17 Apr 2012 – 10:00 PDT

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According to UCB, certolizumab pegol achieved top-level results in a phase 3 study, which assessed the drug’s efficacy and safety in patients with adult-onset active axial spondyloarthritis (AxSpA), a family of inflammatory rheumatic diseases, including ankylosing spondylitis (AS).

Professor Dr Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President at UCB explained:

“The population in this study included both patients with AS and with an early stage of the disease, called non-radiographic axial spondyloarthritis. Both populations are part of a recently defined group of rheumatic diseases, axial spondyloarthritis.

The positive top-line results are very encouraging since there is a need for treatments for patients with non-radiographic AxSpA and for additional effective anti-TNF treatments for AS. Full analysis of the efficacy and safety data of this study is on-going and we look forward to discussing the results with the regulatory authorities.”

325 patients with AxSpA were randomized to either receive 200 mg of certolizumab pegol every two weeks, or 400 mg every four weeks, or placebo after being administered with a loading dose of 400 mg certolizumab pegol at weeks 0, 2 and 4 in a 24-week, multi-center, double blind, placebo-controlled phase 3 study.

Week 12 results demonstrated that compared with patients in the placebo group, a statistically important number of patients who received certolizumab pegol achieved the primary endpoint of at least 20% change in the Assessment of SpondyloArthritis international Society improvement criteria (ASAS20).

The primary endpoint was determined as the ASAS20 improvement criteria, which is defined as a minimum improvement of 20% and overall improvement of at least 1 unit on a scale of 0-10 in a minimum of three categories, including patient global assessment, pain assessment, patient function, and inflammation and absence of deterioration in the remaining domain.

Compared with placebo, the most common and more frequently observed adverse events reported in ≥ 5% of both certolizumab pegol groups consisted of upper respiratory tract infection, elevated liver function tests and abnormal CPK levels. Serious adverse events in both certolizumab pegol groups were similar to those in the placebo group; however, the certolizumab pegol group had a higher incidence of serious infections/infestations.

Cimzia is approved in the U.S. to treat adults with moderately to severely active rheumatoid arthritis and to reduce the signs and symptoms of Crohn’s disease as well as to maintain clinical response in adult patients with moderate to severely active disease, who failed to respond adequately to traditional treatment. In the E.U., Cimzia combined with methotrexate (MTX) is approved to treat moderate to severe active RA in adult patients who failed to respond insufficiently to disease-modifying antirheumatic drugs (DMARDs), such as MTX.

Written By Petra Rattue


Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today

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