Davy James

Patients with relapsing-remitting multiple sclerosis (RRMS) who received a non-myeloablative hematopoietic stem cell transplant (HSCT) experienced improved measures of disability and quality of life, according to a study published by Burt et al, January 20, 2015, in the 

Journal of the American Medical Association

“To our knowledge, this is the first report of significant and sustained improvement in the [Expanded Disability Status Scale] score following any treatment for MS,” the study authors wrote.

The study noted that 50% of patients with MS are unable to maintain employment 10 years from diagnosis and are unable to walk at the 25-year mark. The annual cost of treating MS is approximately $47,000 per patient; however, no therapy approved by the US Food and Drug Administration (FDA) can significantly improve neurologic disability or quality of life, according to the study.

Autologous HSCT is intended to reset the immune system, as opposed to suppressing it. The Burt study evaluated the association between non-myeloablative HSCT and neurologic disability, along with other clinical outcomes, in patients with RRMS treated between 2003 and 2014.

The study included 145 patients with an average follow-up of 2.5 years. Significant improvement was found in 41 patients (50%) tested at 2 years and in 23 patients (64%) tested at 4 years on the EDSS score.

Additionally, HSCT was linked to improvements in physical function, cognitive function, and quality of life. The researchers also observed a reduction in the volume of brain lesions associated with MS. The 4-year relapse-free survival was recorded at 80%, while progression-free survival was 87%.

Patient selection is also a vital factor in determining outcome, the study found.

“In the post hoc analysis, the EDSS score did not improve in patients with secondary-progressive MS or in those with disease duration longer than 10 years,” the authors wrote.

An accompanying editorial by Stephen L. Hauser, MD, noted that autologous HSCT does not appear to be effective in treating established progressive forms of MS and that immunosuppressive regimens with HSCT are apparently effective against RRMS over several years of observation.

“However, it is by no means clear that the beneficial effects result from the infusion of stem cells rather than from the conditioning regimen,” Hauser wrote. “Given the availability of highly effective FDA-approved therapies against relapsing-remitting MS, it would seem reasonable to use these proven monotherapies in the clinical setting before considering complex HSCT regimens.”

1. Burt RK, Balabanov R, Han X, et al. Association of nonmyeloablative hematopoietic stem cell transplantation with neurological disability in patients with relapsing-remitting multiple sclerosis. 

2. Hauser SL. Hematopoietic stem cell transplantation for MS: extraordinary evidence still needed. 

Articles

Patients with relapsing-remitting multiple sclerosis (RRMS) who received a non-myeloablative hematopoietic stem cell transplant (HSCT) experienced improved measures of disability and quality of life.

Stem Cell Transplant May Reduce Disability in Patients with Multiple Sclerosis

This article was originally published on the Specialty Pharmacy Times website.

Stephen Vogt, PharmD, Chief Executive Officer and President of BioPlus Specialty Pharmacy, discusses the ongoing debate surrounding the high price of Hepatitis C treatments versus the efficacy of the drug.

This video was shot at the Armada Health Care 2014 Specialty Pharmacy Summit and Expo in Las Vegas, Nevada.

 to access the full-text version of this article on the Specialty Pharmacy Times website. 

Stephen Vogt, PharmD, Chief Executive Officer and President of BioPlus Specialty Pharmacy, discusses the ongoing debate surrounding the high price of Hepatitis C treatments versus the efficacy of the drug. 

Are Expensive New Hepatitis C Drugs Worth the High Cost? 

A recent study finds the biologic anti-tumor necrosis factor-α (TNF) agent golimumab to maintain its efficacy and safety over a 5-year span for the treatment of the arthritic and dermatologic symptoms of psoriatic arthritis (PsA). 

This Article was oroginally published on the Specialty Pharmacy Times website

The study, published online on April 19, 2014, in Annals of the Rheumatic Diseases, evaluated golimumab in 405 randomized PsA patients. The patients had active PsA, defined as 3 or more swollen and tender joints and active psoriasis. 

The patients were also naive to anti-TNF therapy, with plaque psoriasis that included a qualifying lesion diameter equal to or greater than 2â€…cm regardless of therapy with disease-modifying antirheumatic or nonsteroidal anti-inflammatory drugs. 

The researchers randomly assigned patients into 3 groups that received subcutaneous placebo, 50 mg of golimumab, or 100 mg of golimumab every 4â€…weeks through 20 weeks. Following 24 weeks, all of the patients received 50â€…mg or 100â€…mg of golimumab. Over the 5-year span, 126 patients discontinued treatment. 

The study found at least a 75% improvement in the Psoriasis Area and Severity Index (PASI75) at the 5-year mark in 60.8% to 72.2% of patients with baseline psoriasis involving 3% or more of the body surface area. The treatment was also found to improve nail psoriasis severity.

The researchers noted clinically meaningful improvements in physical function and health-related quality of life scores. Increasing the dose of golimumab yielded an approximately 44% improvement in the PASI scores.

The study found treatment with golimumab led to meaningful improvements in physical function, enthesitis, dactylitis, and skin manifestations, with more than 60% of patients achieving PASI75 improvement after 5 years.

There were minimal changes observed in radiographic scores from baseline to year 5, which suggests a long-term effect of golimumab in inhibiting radiographic progression, the researchers noted. There were no meaningful differences found in the efficacy or safety outcomes between 50 mg and 100 mg doses of golimumab, other than a limited number of patients who developed opportunistic infections in the 100-mg group.

Serious adverse events included 10 patients with basal cell carcinoma; 5 patients with myocardial infarction; 3 patients with cholelithiasis; and 2 patients each with breast cancer, abscess, cellulitis, pneumonia, arthritis, intervertebral disc degeneration, upper abdominal pain, vomiting, tibia fracture, accidental death, chest pain, and superficial thrombophlebitis. Serious infections developed in 15 patients over the course of the study across treatment groups.

The combination of the sustained clinical and radiographic efficacy and safety of the treatment was found to be consistent with other anti-TNF agents used to treat PsA.

“Golimumab dose escalation occurred in approximately one-quarter of randomized patients and, given low discontinuation rates due to lack of golimumab efficacy, likely reflects a treat-to-target therapeutic approach in patients with residual disease activity,” the study authors wrote. - See more at: http://www.specialtypharmacytimes.com/news/Study-Finds-Long-Term-Safety-and-Efficacy-in-Psoriatic-Arthritis-Treatment#sthash.x9x5uYzw.dpuf

Biologic agent golimumab effective over 5-year span in treating disease symptoms and improving quality of life.

Study Finds Long-term Safety and Efficacy in Psoriatic Arthritis Treatment

This article was orginally published on the Specialty Pharmacy Times Website

A recent study finds a direct relationship between the severity of inflammation in psoriatic arthritis (PsA) patients and an increased risk of cardiovascular issues.

 Published on May 14, 2014, in the Annals of Rheumatic Diseases, the study examines the association between the length and severity of joint inflammation with the extent of atherosclerosis in PsA patients. As the main cause of cardiovascular diseases, atherosclerosis causes immune mechanisms to interact with metabolic risk factors, allowing for lesions to form on vascular walls, the study notes.

Examining a cohort of patients with PsA who did not have other traditional cardiovascular risk factors, researchers found that patients with psoriasis are up to twice as likely to develop myocardial infarction as people unaffected by the disease.

“The increased cardiovascular morbidity in psoriatic disease may be partially attributed to the high prevalence of metabolic abnormalities, such as impaired glucose tolerance and atherogenic lipid profile, in these patients,” the study authors wrote. “However, the risk remains increased even after adjustment for these abnormalities, supporting the notion that psoriatic disease is an independent risk factor for cardiovascular events.”

The study analyzed 235 patients with PsA, with about half (44.3%) of the subjects within the first 2 years of initial diagnosis and the remaining patients having established disease at the time of their first visit. Patients with more severe atherosclerosis tended to be older men with a high body mass index, and were more likely to have diabetes, hypertension, or dyslipidemia.

A combination of joint inflammation, higher C-reactive protein levels, and increased PsA disease activity was found to correlate with more severe atherosclerosis.

While the duration of the disease was not found to be associated with severe atherosclerosis, the researchers did find that an elevated erythrocyte sedimentation rate and a higher white blood cell count is associated with more severe atherosclerosis over time. C-reactive protein, which is associated with an increased risk of cardiovascular problems, was not found to be associated with more severe atherosclerosis.

The researchers expressed surprise at the lack of association between disease duration and atherosclerosis, as prior studies of patients with rheumatoid arthritis and lupus found a link between higher cardiovascular risk and disease duration.

“Our results may be explained by the insidious onset of the disease in many patients with PsA, which makes it difficult to determine the exact date of onset,” the authors write. “An alternative explanation may be that the increase in cardiovascular risk is related, partially, to the high prevalence of traditional cardiovascular risk factors that may be present before the onset of PsA.”

Researchers note that future studies are required to determine if progression of atherosclerotic plaques can be prevented through control of inflammation by systemic therapies to reduce the risk of cardiovascular events.

“Overall, these data and our findings indicate that the extent of inflammation over time can explain part of the atherosclerotic process in patients with PsA,” the authors wrote. “These biomarkers may serve to identify patients who are at higher risk of worse disease outcome and cardiovascular events.” - See more at:

http://www.specialtypharmacytimes.com/news/Higher-Inflammation-Burden-in-Psoriatic-Arthritis-Patients-Linked-to-More-Severe-Cardiovascular-Problems#sthash.reDRl8bo.dpuf

 to access the full-text version of this article on the Specialty Pharmacy Times website

Cardiovascular risk related to severity of inflammation, but not associated with disease duration

Author | Davy James

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Stem Cell Transplant May Reduce Disability in Patients with Multiple Sclerosis

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Study Finds Long-term Safety and Efficacy in Psoriatic Arthritis Treatment

Higher Inflammation Burden in Psoriatic Arthritis Patients Linked to More Severe Cardiovascular Problems