Morgan Petronelli

There are multiple factors predicting itch-specific quality of life in patients with chronic itch, according to a video oral abstract presentation at the American Society for Dermatologic Surgery (ASDS) Annual Meeting.1 

“Itch is a common dermatological symptom, and it can severely affect the quality of life of patients,” said Siri Choragudi, a research fellow at the University of Miami Miller School of Medicine in Florida. 

Study investigators sought to evaluate the sociodemographic and itch-specific factors that predict the itch-specific quality of life in patients with chronic itch. In the cross-sectional study, investigators recruited a cohort of male and female patients 18 years or older who attended an itch clinic in Miami from 2016 to 2022 with reports of itching for at least 6 weeks.

Investigators used an interviewer-administered questionnaire to report sociodemographic and itch-related factors, which included the following:

Itch location (head and neck, upper limb, lower limb, trunk, groin, buttocks)

Worsening factors (stress, dry skin, sweat, contact with irritants or allergens, hot water, foods, salt water, acidic drinks)

Associated symptoms (pain, rash, sweating, hot and cold sensations)

Responses were recorded using an itch-specific quality of life questionnaire, ItchyQoL, then each response was graded using a 5-point Likert rating scale.

The study included 534 patients, with a mean age of 58 years; 59% were women and 62% were non-Hispanic White. Results of the study demonstrated a mean intensity of itch of 8, 45% of patients had itch all day and night, and 40% had pain in the area of itch. Additionally, dry skin was the most common worsening factor (52%). Itch was most frequent in the upper limb (80%), trunk (73%), and lower limb (68%). The mean total itch-specific quality of life was 72 (range, 21-105).

The investigators noted that being non-Hispanic White predicted good quality of life compared with other ethnicities.“ In summary, sociodemographic factors such as female sex; body site location such as groin, buttocks, and upper limb; and worsening factors such as pain and heat in the itch area had the highest predictive value of poor quality of life in [patients with] chronic itch,” Choragudisaid. 

1. Yosipovitch G, Choragudi S. Factors predicting the itch-specific quality of life among patients suffering from chronic itch. Presented at: American Society for Dermatologic Surgery Annual Meeting; October 6-10, 2022; Denver, CO.

Articles

Several factors predict itch-specific quality of life in patients with chronic itch. 

Evaluating Chronic Itch and Quality of Life 

ImmunoGen recently announced that the US Food and Drug Administration has granted accelerated approval to the company’s first-in-class antibody-drug conjugate (ADC), mirvetuximab soravtansine-gynx (ELAHERE).

ELAHERE is now approved for the treatment of adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have also received 1-3 prior systemic treatments.

Accelerated approval of ELAHERE is based on objective response rate (ORR) and duration of response (DOR) data from the SORAYA trial. Notably, continued approval may be contingent upon results in a confirmatory trial.

In a single-arm study within the SORAYA trial, ELAHERE was investigated in 106 patients with platinum-resistant ovarian cancer, had tumors with high levels of FRα, and who had been treated with 1-3 systemic treatment regimens prior to the study.

The primary endpoint included confirmed ORR as observed by an investigator and the secondary endpoint was DOR.

In the study, ELAHERE showed an ORR of 31.7% (95% confidence interval [CI]: 22.9, 41.6), as well as 5 complete responses (CRs). Also, the median DOR was 6.9 months (95% CI: 5.6, 9.7).

As for the safety of ELAHERE, the drug has been assessed in a pooled analysis from 3 studies, totaling 464 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received at least 1 dose of ELAHERE.

Common adverse reactions included increased aspartate aminotransferase, laboratory abnormalities, vision impairment, diarrhea, decreased albumin, abdominal pain, fatigue, nausea, keratopathy, decreased lymphocytes, peripheral neuropathy, constipation, dry eye, decreased magnesium, increased alkaline phosphatase, decreased neutrophils, decreased leukocytes, and decreased hemoglobin.

Additionally, ELAHERE includes a boxed warning within the prescribing information for ocular toxicity, such as visual impairment, photophobia, eye pain, keratopathy, dry eye, and uveitis.

"The approval of ELAHERE is significant for patients with FRα-positive platinum-resistant ovarian cancer, which is characterized by limited treatment options and poor outcomes,"

said Ursula Matulonis, MD, chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, professor of medicine at Harvard Medical School, and SORAYA coprincipal investigator. “ELAHERE’s impressive anti-tumor activity, durability of response, and overall tolerability observed in SORAYA demonstrate the benefit of this new therapeutic option, and I look forward to treating patients with ELAHERE."

This article originally appeared on Contemporary OB/GYN.

ImmunoGen Announces FDA Accelerated Approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the Treatment of Platinum-Resistant Ovarian Cancer. Immunogen. November 14, 2022. Accessed November 17, 2022. 

https://investor.ImmunoGen.com/news-releases/news-release-details/immunogen-announces-fda-accelerated-approval-elaheretm

This is the first FDA-approved ADC for platinum-resistant disease, according to ImmunoGen.

Accelerated Approval to Mirvetuximab Soravtansine-gynx Granted by FDA

Women with a history of migraine are more likely to also experience poor sleep, especially during the menopause transition, according to research presented at the North American Menopause Society (NAMS) Annual Meeting.

Not only do women experience migraines and poor sleep more often than men, but poor sleep also costs the US economy roughly $411 billion per year, affecting work productivity, absenteeism, and impairment on women’s quality of life.

While an association between migraines and sleep quality has been established in previous studies, studies are lacking when it comes to poor sleep and migraines during the menopause transition.

In an effort to investigate the relationship between poor sleep and migraines during the menopause transition, researchers from the Mayo Clinic studied and compared 2000 perimenopausal and premenopausal women, considering potential confounding variables.

"To our knowledge, this is the first study to examine the association between migraine and sleep quality in pre-compared to perimenopausal women using validated tools in a large cohort of women across three geographical locations,” said Summer Ghaith, lead author of the study from the Mayo Clinic School of Medicine.

Results of this cross-sectional study demonstrated a link between the history of migraine and poor sleep quality in both premenopausal and perimenopausal women.

“Given the rise of both migraine and sleep disturbances during the menopause transition, we were interested to see whether the relationship between these two entities changes as women advance through the reproductive stages, and that is exactly what we found. In contrast to the findings in premenopausal women, the association appears to be driven by other factors in perimenopausal women,” said Ghaith.

Study results also found that in perimenopausal women compared to premenopausal women, the relationship between poor sleep during the menopause transition can be influenced by body mass index, depression, anxiety, and hot flashes compared

"Clinicians caring for women with migraine should ask about their sleep quality regardless of menopause status, although management strategies to address poor sleep in migraine sufferers may differ depending on menopause status," said Stephanie Faubion, MD, MBA, NAMS medical director.

1. Ghaith S. Does a history of migraines mean you're more likely to be a poor sleeper. Presented at: North American Menopause Society Annual Meeting. October 12-15, Atlanta, Georgia.

History of migraine may be associated with poor sleep in premenopausal and perimenopausal women, according to research presented at the North American Menopause Society Annual Meeting.

Poor Sleep in Premenopausal and Perimenopausal Women Linked to Migraine History

With the continuing rise in monkeypox infections in the United States, the US Food and Drug Administration has granted Emergency Use Authorization (EUA) of the Jynneos (Bavarian Nordic) vaccine for pediatric patients <18 years who are at high risk of monkeypox infection.

Now, the vaccine is authorized for a series of 2, 0.5 mL doses via subcutaneous injection administered 28 days apart in patients <18 years and patients of any age who have a history of developing keloid scars under the new EUA. Additionally, an alternative regimen of 2, 0.1 mL doses via intradermal injections administered 28 days apart is authorized for use in patients ≥18 years.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” said FDA Commissioner Robert M. Califf, MD “The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.”

Jynneos, a Modified Vaccinia Ankara (MVA) vaccine, was approved for the prevention of smallpox and monkeypox in adults 18 years and older in 2019.

This article originally appeared on Contemporary Pediatrics.

1. Monkeypox update: FDA authorizes emergency use of Jynneos vaccine to increase vaccine supply. FDA. Published August 9, 2022. Accessed August 10, 2022. 

https://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply

The FDA has granted Emergency Use Authorization EUA of the Jynneos vaccine for pediatric patients <18 years who are at high risk of monkeypox infection.

FDA Gives OK to Pediatric Use of Monkeypox Vaccine

Myovant announced the FDA has approved relugolix combination tablets (Myfembree; Myovant Sciences and Pfizer) for the treatment of moderate-to-severe endometriosis-associated pain.

Previously, Myfembree was only approved for the management of uterine fibroid-related heavy menstrual bleeding in premenopausal women.

“This approval is an important milestone reflecting Pfizer and Myovant’s commitment to women’s health in areas of significant unmet need,” said James Rusnak, MD, PhD, senior vice president, chief development officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We look forward to making Myfembree available to women with endometriosis and broadening their options in managing this complex disorder.”

This decision by the FDA is supported by positive data from two phase 3 studies (SPIRIT 1 and SPIRIT 2) investigating the combination tablet for treatment of dysmenorrhea.

In both studies, 75% of women using the once-daily relugolix combination therapy experienced a significant reduction in dysmenorrhea, compared to 27% and 30% of women in the placebo groups at Week 24, respectively (both 

 < 0.0001). Relugolix combination therapy also significantly reduced non-menstrual pelvic pain in 59% and 66% of women, compared to 40% and 43% in the placebo groups (

In SPIRIT 1 and 2, the relugolix combination therapy group also showed reductions in dyspareunia and opioid use compared to the placebo groups. Additionally, more women undergoing relugolix combination therapy were opioid free at Week 24 compared with placebo (86% and 82% vs 76% and 66%, respectively).

The most frequently reported adverse events by women in both the relugolix combination therapy and placebo groups included headaches, nasopharyngitis, and hot flashes.

"The data from the SPIRIT studies showed the clinical benefit that relugolix combination therapy can have on moderate to severe pain associated with endometriosis and how it can impact patients,” said Linda Giudice, MD, PhD, distinguished professor at the University of California, San Francisco (UCSF), and chair, SPIRIT Program Steering Committee. “This newly approved option for patients with pain from endometriosis offers the convenience of one pill taken once daily with a mean change in bone mineral density of <1% that did not appear to worsen at 12 months of treatment; however, monitoring is recommended.”

Myfembree is now available with a prescription to patients with moderate-to-severe pain associated with endometriosis.

1. Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis. Myovant Sciences. August 5, 2022. Accessed August 5, 2022. 

https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-and-pfizer-receive-us-fda-approval-myfembreer

2. Giudice LC, As-Sanie S, Arjona Ferreira JC, et al. Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomized, double-blind, studies (SPIRIT 1 and 2). 

. 2022;399(10343):2267-2279. doi:10.1016/s0140-6736(22)00622-5

Myovant Sciences and Pfizer announces the FDA has approved the therapy for the once-daily treatment of moderate-to-severe endometriosis-associated pain.

Myfembree Approved by FDA for Treating Endometrial Pain

HRA Pharma, a Perrigo company, has announced it submitted an application to the US Food and Drug Administration (FDA) for possible future approval of the first-ever OTC birth control pill.

This application is for an Rx-to-OTC switch for Opill (HRA Pharma), which is a progestin-only (or non-estrogen) daily birth control pill. Currently, Opill is approved by the FDA in 1973

 to prevent pregnancy and has been an available progestin-only option for more than 50 years.

In a company press release announcing the submission, HRA Pharma said that removing the prescription hurdle to the pill would in turn improve access to a contraceptive “that is well tolerated and notably more effective at preventing pregnancy than all current methods available OTC.”

American College of Obstetricians and Gynecologists

, have all voiced support for making birth control pills available OTC.

"As a doctor, I am dedicated to empowering people to make decisions about pregnancy prevention. For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach," said obstetrician-gynecologist, Melissa J. Kottke, MD, MPH, MBA. "Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health."

An approval decision is expected sometime next year, according to the company.

1. Perrigo’s hra pharma submits application to fda for first-ever otc birth control pill. HRA_Pharma. Published July 11, 2022. Accessed July 11, 2022. 

https://www.hra-pharma.com/articles/perrigos-hra-pharma-submits-application-to-fda-for-first-ever-otc-birth-control-pill-66

Perrigo’s HRA Pharma has submitted an application to the FDA for possible future approval of the first-ever OTC birth control pill.