Brett King, MD, PhD, from the Yale School of Medicine in New Haven, Connecticut, and colleagues reported pooled 68-week results from 2 open-label extension (OLE) trials of the THRIVE-AA1/AA2 trials. Participants in a qualifying study who completed 24 weeks of dosing with deuruxolitinib were eligible for OLE trials. Every 4 weeks for the first 12 weeks and every 8 weeks thereafter, the Severity of Alopecia Tool (SALT) score was measured.

The researchers found that from baseline, there was a decrease in the mean SALT scores in participants who received any dose of deuruxolitinib in qualifying studies and OLEs (86.8 to 26.8). The proportion of participants achieving a SALT score less than 20 was 34.9% at the conclusion of the qualifying study (week 24) and increased to 62.6% at week 68. Increasing efficacy was seen for both the 8mg and 12mg twice-daily doses with a last-observation-carried-forward (LOCF) imputation analysis and an as-observed (AO) analysis. The proportion of patients achieving a SALT score 20 or less at week 68 was 48.8 and 60.9% for 8mg and 12mg twice daily, respectively, for LOCF, and 76.6 and 66.7%, respectively, for AO.

“Scalp hair regrowth up to 68 weeks showed continuous, clinically meaningful improvements in adults with alopecia areata taking deuruxolitinib,” the authors write.

The THRIVE-AA1/AA2 trials were sponsored by Concert Pharmaceuticals, the manufacturer of deuruxolitinib.

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Increased rates of APOs are associated with rheumatic diseases like SLE, rheumatoid arthritis (RA), and dermatomyositis, but little is known about pregnancy outcomes among patients with ASDs. Therefore, researchers conducted a case-control study to assess the frequency of APOs among women with ASDs.

Data were taken from the TriNetX United States Collaborative Network database and included patients aged between 15 to 44 years who were pregnant, from January 1, 2016, to December 31, 2021.

Patients with ASDs were propensity score matched 1:1 with members of two control groups for comparison: 1) healthy patients without ASDs, RA, or SLE and 2) individuals with RA or SLE who were considered members of the disease-control group.

The study included 3654 patients with ASDs and 3654 members of the control groups (2147 patients with SLE and 889 with RA).

Patients with ASDs were at greater risk of experiencing spontaneous abortion and preeclampsia/eclampsia compared with members of the healthy control group.

Specifically, the risk for spontaneous abortion was 1.5 times higher among patients with ASDs than in the healthy control group (P <.001), while the risk for preeclampsia/eclampsia was 1.2 times higher among patients with ASDs compared with the healthy control group (P =.04).

Compared against women with SLE, women with ASDs were less likely to experience preeclampsia/eclampsia, have a preterm birth, experience preterm premature rupture of membranes (PPROM), or have a fetus with intrauterine growth restriction (IUGR).

Specifically, the risk for preeclampsia/eclampsia was 0.7 times lower (P =.001), the risk of delivering preterm was 0.5 times lower (P <.001), the risk for PPROM was 0.6 times lower (P =.004), and the risk of having a fetus with IUGR was 0.6 times lower (P <.001) among women with ASDs vs women with SLE.

Women with ASDs were more 1.2 times more likely to experience a spontaneous abortion than women with SLE (P =.003). Patients with ASDs and RA were at similar risk for APOs.

The study authors concluded, “These results suggest that patients with ASDs have increased rates of adverse pregnancy outcomes compared to healthy controls and are similar in risk to RA. In contrast, those with SLE have a greater frequency of APOs indicating that all these groups may benefit from multidisciplinary care with maternal-fetal medicine specialists.”

Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

The table below is a review of notable updates that occurred in April 2023 for investigational products in development (not an inclusive list). Click on the status to view our full coverage.

Bimzelx^® (bimekizumab-bkzx) is now available for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

Bimzelx is a humanized interleukin-17A and F antagonist. The safety and efficacy of Bimzelx was established in three phase 3 trials (ClinicalTrials.gov Identifier: BE VIVID [NCT03370133],  BE READY [NCT03410992]), and BE SURE [NCT03412747]), which included 1480 adults with moderate to severe plaque psoriasis.

The prescribing information for Bimzelx includes risks associated with suicidal ideation and behavior, tuberculosis, liver biochemical abnormalities, and inflammatory bowel disease. The most common adverse reactions reported with treatment were upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue. 

Bimzelx is available as a single-dose prefilled autoinjector or prefilled syringe containing 160mg/mL of solution. Treatment is administered as 320mg subcutaneously every 4 weeks for the first 16 weeks, followed by every 8 weeks thereafter. Following appropriate training from their health care provider, patients may self-inject Bimzelx. 

To help eligible patients to gain access to Bimzelx, UCB is offering patient support through Bimzelx Navigate.

“While the treatment landscape for psoriasis has evolved in recent years, many unmet needs remain for the more than 7.5 million adults in the US living with the disease,” said Dr Jeffrey Stark, Head of Medical, US Immunology, UCB. “With Bimzelx now available, patients and their healthcare providers have access to a treatment that has proven to consistently deliver rapid, complete, and maintained skin clearance from the first dose.”

HealthDay News — There are considerable shortages of oral minoxidil 2.5mg and 10mg tablets, used for treatment of androgenetic alopecia, within the District of Columbia, Maryland, and Northern Virginia (DMV) area, according to a research letter published online October 26 in the Journal of Drugs in Dermatology.

Sapana Desai, MD, from George Washington University School of Medicine and Health Sciences in Washington, DC, and colleagues evaluated current inventories of oral minoxidil at mainstream pharmacies in surrounding neighborhoods of DMV during the first week of October 2023.

The researchers found that 23% of all 143 Northern Virginia pharmacies confirmed availability of both oral minoxidil 2.5 and 10mg tablets, with adequate inventories for 30-day supplies. In Washington, DC, and Maryland pharmacies, limited reserves for both dosages were also reported (17.9 and 14.9%, respectively). Overall, 40.1 and 29.6% of all contacted DMV pharmacies reported availability of low-dose oral minoxidil 2.5mg and oral minoxidil 10mg tablets, respectively, for a 30-day supply. The greatest deficit in oral minoxidil availability was seen in Maryland; 28.3 and 22.3% of the state’s pharmacies confirmed 30-day supplies of low-dose oral minoxidil 2.5mg and oral minoxidil 10mg tablets, respectively.

“Such paucities pose a challenge both for dermatologists managing androgenetic alopecia but also primary care physicians utilizing this medication on label,” the authors write.

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HealthDay News — Crisaborole is effective as a long-term maintenance therapy for pediatric and adult patients with mild-to-moderate atopic dermatitis (AD), according to a study published online May 15 in the American Journal of Clinical Dermatology.

Lawrence F. Eichenfield, MD, from the University of California San Diego and Rady Children’s Hospital-San Diego, and colleagues examined long-term efficacy and safety of crisaborole once daily (QD) vs vehicle QD as maintenance therapy for patients (aged ≥3 months) with mild-to-moderate AD. Eligible patients received crisaborole twice daily during an open-label run-in period of up to 8 weeks and were then randomly assigned to receive crisaborole or vehicle QD (135 patients in each group).

The researchers found that patients who received crisaborole vs vehicle had longer median time of flare-free maintenance (111 vs 30 days). For patients who received crisaborole vs vehicle, the mean number of flare-free days was higher (234.0 vs 199.4 days). In addition, patients receiving crisaborole had a lower mean number of flares (0.95 vs 1.36). No clear trend was observed between the groups in maintenance of pruritus response. Crisaborole was well tolerated, with no new safety findings for use as maintenance treatment.

“Crisaborole QD is effective as a long-term maintenance therapy, demonstrating a significant reduction in the incidence of AD-related flares compared to vehicle in pediatric (aged ≥3 months) and adult patients with mild-to-moderate AD,” the authors write.

Several authors disclosed ties to biopharmaceutical companies, including Pfizer, which manufactures crisaborole and funded the study.

Abstract/Full Text

Drug-Induced Photosensitivity

The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for dupilumab for the treatment of patients 12 years of age and older with chronic spontaneous urticaria (CSU) that is inadequately controlled with standard-of-care (SOC), H1 antihistamines.

The sBLA is supported by data from Studies A and B of the randomized, double-blind, placebo-controlled phase 3 LIBERTY-CUPID trial (ClinicalTrials.gov Identifier: NCT04180488), which evaluated the efficacy and safety of dupilumab in patients with CSU. Study A included patients who were inadequately controlled on SOC antihistamines; and Study B included patients who were inadequately controlled on SOC antihistamines and refractory to omalizumab.

In Study A, treatment with dupilumab plus SOC antihistamines met the primary endpoint achieving a 63% reduction in itch severity in biologic-naive patients at week 24 compared with a 35% reduction with antihistamines alone (10.24 point reduction vs 6.01 point reduction, respectively; P <.001). Moreover, the addition of dupilumab met all key secondary endpoints.

Findings from Study B showed that treatment with dupilumab achieved positive numerical trends in reducing itch and hives; however, it failed to meet statistical significance during an interim analysis conducted by an independent review committee. The Company decided to discontinue Study B in February 2022 due to futility.

The FDA has set a target action date of October 22, 2023 for the application.

Dupilumab is currently marketed under the brand name Dupixent^® and is approved for the treatment of moderate to severe atopic dermatitis in patients 6 months of age and older; for maintenance treatment of severe asthma in patients 6 years of age and older; chronic rhinosinusitis with nasal polyps in patients 18 years of age and older; eosinophilic esophagitis in patients 12 years of age and older; and for prurigo nodularis in patients 18 years and older.

References

1. Dupixent^® (dupilumab) application for treatment of chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older accepted for FDA review. News release. Regeneron Pharmaceuticals, Inc. Accessed March 7, 2023. https://www.globenewswire.com/news-release/2023/03/07/2621674/0/en/Dupixent-dupilumab-Application-for-Treatment-of-Chronic-Spontaneous-Urticaria-CSU-in-Adults-and-Adolescents-Aged-12-Years-and-Older-Accepted-for-FDA-Review.html.
2. Dupixent^® (dupilumab) significantly improved itch and hives in patients with chronic spontaneous urticaria, a step forward in demonstrating the role of type 2 inflammation in these patients. News release. Regeneron Pharmaceuticals, Inc. July 29, 2021. Accessed March 7, 2023. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-significantly-improved-itch-and-hives/.

The discontinuation of postmarketing quality, regulatory and pharmacovigilance activities means that the Company is unable to support or guarantee that the medications will meet all intended specifications through the labeled shelf life of the product.

The affected products include:

• Cloderm (clocortolone pivalate) 0.1% cream; 45g tube; NDC# 71403-0804-45; Lot#/Expiry dates:  SDFC- 5/31/2024 and TFBW- 5/31/2025;
• Minolira (minocycline) ER 105mg tablet; 30-count bottle; NDC# 71403-0101-30; Lot#/Expiry dates: T2300765- 11/30/2025, T2201702A-02/28/2025, T2201699- 2/28/2025, and T2201698- 2/28/2025; and
• Minolira (minocycline) ER 135mg tablet; 30-count bottle; NDC# 71403-102-30; Lot#/Expiry dates: T2201700- 02/28/2025 and T2201701- 02/28/2025.

According to the Company, only the products and lot numbers listed are affected by this recall. Further distribution or use of these recalled products should be discontinued immediately. Products with lot numbers not included in this list are owned and distributed by a different company and will remain on the market.

To date, the Company has not received any reports of adverse events related to this recall. Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program.

Nita K.F. Wienholtz, MD, PhD, from Copenhagen University Hospital-Rigshospitalet in Denmark, and colleagues examined the effectiveness, tolerability, and safety of erenumab for treatment of rosacea-associated erythema and flushing in a single-center, nonrandomized trial involving adults with rosacea with at least 15 days of moderate-to-severe erythema and/or moderate-to-extreme flushing. Participants received 140mg erenumab subcutaneously every four weeks for a period of 12 weeks; safety was assessed at week 20.

Thirty participants were included; 27 completed the study. The researchers observed a reduction of −6.9 days in the mean number of days with moderate-to-extreme flushing, from 23.6 days at baseline. For moderate-to-severe erythema, the mean number of days was reduced by −8.1 from 15.2 at baseline. Adverse events included transient mild-to-moderate constipation, transient worsening of flushing, bloating, and upper respiratory tract infection (33, 13, 10, and 10%, respectively). One participant discontinued the study due to a serious adverse event, deemed unrelated to the study, and 2 withdrew consent due to time constraints.

“The results also suggest that erenumab is generally well tolerated, with mild and/or transient adverse effects,” the authors write. “Larger randomized, controlled, double-blind studies are necessary to confirm these findings and to investigate the long-term effects of erenumab treatment.”

Several authors disclosed ties to pharmaceutical companies, including Novartis Pharma, which funded the study.

Abstract/Full Text (subscription or payment may be required)

Editor’s Note (subscription or payment may be required)