PHARMACY

FDA approves updated labeling for Simponi Aria

BY David Salazar

HORSHAM, Pa. — The Food and Drug Administration this week approved expanded labeling for Janssen Biotech’s rheumatoid arthritis treatment Simponi Aria (golimumab for infusion). The revised label now notes that the drug, in combination with methotrexate, can improve patients’ physical and emotional well-being, as measured by a Medical Outcomes Study Short Form-36 questionnaire. 

“The SF-36 is a general health assessment that allows people receiving treatment for RA to share the physical and mental impact of the disease in their own words,” J&J Pharmaceutical Services VP patient reported outcomes Pauline McNulty said. “In today's healthcare environment, patient-reported outcomes are more important than ever as they enable healthcare providers to engage patients in making decisions that impact their health-related quality of life.”

The company said that results from the SF-36, collected as art of the Go-Further trial, showed that those being treated with SImponi Aria and methotrexate showed a greated improvement over the baseline than the placebo group across all eight physical and mental composite scores over the course of 24 weeks. 

“Traditional assessments of RA treatments measure joint function and pain, but we as clinicians know that there is much more to this disease,” Dr. Jeffrey Curtis, of the University of Alabama at Birmingham’s division of clinical immunology and rheumatology said. “Measuring physical, mental and social function can provide a more comprehensive view of how RA treatment impacts patient lives.” 

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Study: PrEP demonstrates effectiveness, but alongside growing STI rate

BY David Salazar

SAN FRANCISCO — The findings from a study published in this month’s issue of Clinical Infectious Diseases tout the effectiveness of HIV pre-exposure prophylaxis (PrEP), marketed as Truvada (tenofovir/embtricitabine). According to the study — completed with information from patients at the Kaiser Permanente San Francisco Medical Center — though the rates of sexually transmitted diseases have gone up among PrEP users, the population examined saw no new HIV infections. 

The study looked at 657 individuals beginning PrEP at the medical center (99% of whom were men who have sex with men). After six months, 30% were diagnosed with any STI,  a number that grew to 50% after 12 months. However, when looking at 388 person-years of follow-up (meaning the cumulative time all participants were taking PrEP), nthere were no diagnoses of HIV. This is also despite the fact that 41% of 143 users had decreased condom use after 6 months.

According to the study’s authors, in a group with similarly high rate of STIs, they would expect and 8.9 out of 100 person-years incidence of HIV without PrEP use. And though the study has the limitations — the authors cite lack of a control group, higher rates of HIV incidence and viral undetectability in San Franciso and the lack of information on the HIV status of the participants’ partners, the results point to PrEP’s promise even in high-risk populations.

Additionally, in a commentary on the study, Kimberly Koester of the University of California, San Francisco, and Robert Grant of UCSF, Gladstone Institutes and the San Franciso AIDS Foundation, noted that the study demonstrates the ability for PrEP treatment to be integrated into primary care visits — something they say isn’t always the case among MSM, who may get PrEP at community clinics or elsewhere.

“It is time for a vigorous conversation about sexually transmitted infections, too long eclipsed by fear of HIV infection. The conversation should include public health officers, clinicians, clients and sexual partners,” Koester and Grant wrote. “Idally the public health response to the possibility of rising incidence of STIs int eh context of decreased or no new HIV infections would be framed in relative terms and therefore considered to be a good problem to have.”

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FDA approves Brilinta 60 mg tablets

BY Lesley Thulin

WILMINGTON, Del. — AstraZeneca on Thursday announced that the Food and Drug Administration approved Brilinta (ticagrelor) tablets at a 60 mg dose for patients with a history of heart attack beyond the first year.

Brilinta is intended to reduce the rate of cardiovascular death, heart attack and stroke in patients with acute coronary syndrome.

"We know that patients remain at risk beyond the first year after their heart attack," said Elisabeth Björk, VP and head of Cardiovascular and Metabolic Diseases for AstraZeneca’s global medicines development division. "Today's approval provides an important new treatment option and underscores the role Brilinta can play in reducing the risk of a subsequent cardiovascular event for patients both in the acute setting and in the longer term."

First approved by the FDA in 2011, the oral antiplatelet treatment inhibits platelet activation and reduces the rate of stent thrombosis, according to AstraZeneca.

The recommended maintenance dose of Brilinta is 90 mg twice daily for the first year after an ACS event. It should be used with a daily maintenance dose of aspirin of 75-100 mg.

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