The new guidelines include 18 evidence-based recommendations and 5 good practice statements resulting from a systematic review conducted by an expert panel. For patients over the age of 9 years, strong recommendations were made for the use of topical therapies such as benzoyl peroxide and retinoids (eg, adapalene, tretinoin, tazarotene, trifarotene), either as monotherapy or combined. Topical antibiotics were also strongly recommended though not as monotherapy. A strong recommendation was made for fixed-dose topical combination therapies as these agents could help with adherence, and in some cases, may be less expensive than prescribing the individual components separately.

With regard to systemic antibiotics, the panel strongly recommended the use of doxycycline and conditionally recommended minocycline and sarecycline based on the available evidence. In general, oral antibiotics should be used concomitantly with benzoyl peroxide and other topical therapies. Limiting the use of systemic antibiotics to the shortest possible duration helps to reduce the development of antibiotic resistance and antibiotic associated complications.

Additional good clinical practices highlighted in the guidelines include the following:

• Intralesional corticosteroid injections may be used as an adjuvant therapy in patients with larger acne papules or nodules.
  • Consider use in patients at risk for acne scarring and for those who need rapid inflammation and pain improvement.
  • Risk of local adverse events may be minimized by using a lower concentration and volume of corticosteroid. 
• Isotretinoin is recommended for patients with severe acne or for those who have failed other oral and topical therapies.
  • Patients with psychosocial burden or acne scarring should be considered candidates for isotretinoin.
  • Monitoring of liver function tests and lipids should be considered in these patients, though complete blood count is not necessary in healthy individuals.
  • Pregnancy prevention is mandatory for patients of childbearing age.

Based on individual patient factors, conditional recommendations were also made for the use of topical clascoterone, topical salicylic acid, topical azelaic acid, and hormone therapies (eg, combined oral contraceptives, spironolactone).

The full report, which also includes information on physical modalities (eg, acne lesion extraction, chemical peels, laser and light-based devices, microneedle radiofrequency devices, photodynamic therapy), complementary and alternative therapies (eg, vitamins, botanical and plant-derived agents) and diet, is available here.

The American Academy of Dermatology (AAD) has released updated guidelines on the management of atopic dermatitis with topical therapies in adults.

Developed by a multidisciplinary workgroup, strong recommendations were made for both prescription and nonprescription therapies in which the benefits clearly outweighed the potential risks. These included moisturizers, topical calcineurin inhibitors (pimecrolimus 1% cream and tacrolimus 0.03% or 0.1% ointment), topical costicosteroids, topical phosphodiesterase-4 inhibitors (crisaborole 2% ointment), and topical Janus kinase inhibitors (ruxolitinib 1.5% cream).

The experts also conditionally recommended bathing for the treatment and maintenance of atopic dermatitis and wet wrap therapy for adult patients with moderate to severe disease experiencing a flare.  

Due to the low certainty of evidence, the workgroup conditionally recommended against the use topical antimicrobials, antiseptics, and antihistamines. The experts noted that bleach baths or topical sodium hypochlorite may be suggested to reduce diseases severity in patients with moderate to severe atopic dermatitis and clinical signs of secondary bacterial infection.

“Atopic dermatitis is the most common type of eczema, and it can interfere with a person’s daily life without proper treatment,” said board-certified dermatologist Robert Sidbury, MD, MPH, FAAD, co-chair of the AAD’s Atopic Dermatitis Guideline Workgroup. “The guidelines provide evidence-based recommendations for dermatologists to use in caring for their adult atopic dermatitis patients with topical treatments, which have come a long way since the guidelines were last revised in 2014. This update reflects the latest advances in topical medications that are now available to help adults with atopic dermatitis.”

The full guidelines can be viewed here.

References

1. American Academy of Dermatology issues updated guidelines for the management of atopic dermatitis in adults with topical therapies. News release. January 12, 2023. https://www.prnewswire.com/news-releases/american-academy-of-dermatology-issues-updated-guidelines-for-the-management-of-atopic-dermatitis-in-adults-with-topical-therapies-301720824.html.
2. Sidbury R, Alikhan A, Bercovitch L, et al. Guidelines of care for the management of atopic dermatitis in adults with topical therapies. Published online January 11, 2023. Journal of the American Academy of Dermatology. doi.org/10.1016/j.jaad.2022.12.029

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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Andrew Alexis, MD, MPH, from Weill Cornell Medicine in New York City, and colleagues conducted ADmirable, a phase 3b, open-label, 24-week study to evaluate lebrikizumab in adults and adolescents with atopic dermatitis and skin of color. Interim data were presented for 50 patients aged 12 years and older with Fitzpatrick Phototype IV to VI. Self-reported race of the patients was 80% Black/African-American, 14% Asian, and 6% American Indian/Alaska Native. Patients were administered a 500mg loading dose of lebrikizumab at baseline and week 2 followed by a 250mg dose every 2 weeks up until week 16.

The researchers found that at week 16, 68.3% of patients achieved a 75% or greater reduction in the Eczema Area and Severity Index (EASI 75) and 39.0% achieved an Investigator’s Global Assessment of 0 or 1 with 2-point or greater improvement. The mean change and percentage change in the EASI were –22.2 and –79.1%, respectively; the corresponding changes in the Pruritis Numeric Rating Scale were –4.0 and –53.9%. Improvement in mean percentage change for hypopigmented and hyperpigmented lesions was also identified on the PDCA-Derm, a new scale used to describe postinflammatory lesions compared to unaffected skin. No serious adverse events were reported.

“People with skin of color are disproportionately affected by atopic dermatitis, often experiencing more severe symptoms, a delay in diagnosis, and a lengthier timeframe to find appropriate treatment,” Alexis said in a statement. “They also have been historically underrepresented in clinical trials, which means we have lacked data pertaining to the treatment of patients with skin of color. With these initial results, [we are] taking a step toward investigating the needs of people with skin of color affected by atopic dermatitis.”

Several authors disclosed ties to Eli Lilly, which manufactures lebrikizumab and funded the study.

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HealthDay News — For patients with nonsegmental vitiligo, continued improvement in seen during a long-term extension of ruxolitinib treatment, according to study presented at the annual meeting of the American Academy of Dermatology, held from March 17 to 21 in New Orleans.

Noting that ruxolitinib cream demonstrated facial and total body repigmentation over 52 weeks in two phase 3 vitiligo studies (TRuE-V1/TRuE-V2), David Rosmarin, MD, from the Indiana University School of Medicine in Indianapolis, and colleagues examined shifts in facial/total Vitiligo Area Scoring Index (F-VASI/T-VASI) responses over an additional 52 weeks of open-label ruxolitinib treatment among patients aged 12 years or older who did not achieve 90% or greater improvement in F-VASI (F-VASI90) at week 52.

The researchers found that 66.1% of the 222 patients initially randomly assigned to ruxolitinib achieved F-VASI75 at week 104, up from 30.8 percent at week 52 and 54.6% at week 80; a corresponding increase in T-VASI50 was seen, from 42.5 and 57.7 to 63.8%. At week 104, 30.9% attained F-VASI90. At week 80, 36.2 and 47.1%, respectively, remained stable and had improvement in F-VASI responses attained at week 52; 51.1 and 31.7%, respectively, remained stable and had improvement in T-VASI responses attained at week 52. Compared with results attained at week 80, at week 104, 64.4 and 19.6%, respectively, remained stable and had improvement in F-VASI responses, while 61.3 and 22.2%, respectively, remained stable and had improvement in T-VASI responses.

“Vitiligo is a chronic condition and these results demonstrate the long-term potential of this medical treatment for people with vitiligo who are interested in repigmentation,” Rosmarin said in a statement.

Several authors disclosed financial ties to pharmaceutical companies, including Incyte, which manufactures ruxolitinib and sponsored the study.

Poster Presentation

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HealthDay News — For patients with moderate-to-severe hidradenitis suppurativa (HS), bimekizumab shows promise in phase 3 trials, according to research presented at the annual meeting of the American Academy of Dermatology, held from March 17 to 21 in New Orleans.

Alexa B. Kimball, MD, MPH, from Harvard Medical School in Boston, and colleagues conducted two phase 3 studies involving patients with HS (BE HEARD I with 505 participants and BE HEARD II with 509 participants). The trials included a 16-week initial and 32-week maintenance treatment period. Patients with moderate-to-severe HS were randomly assigned to receive (initial/maintenance) bimekizumab 320mg every two weeks (Q2W)/Q2W, bimekizumab Q2W/Q4W, bimekizumab Q4W/Q4W, and placebo/bimekizumab Q2W in a 2:2:2:1 ratio. Bimekizumab Q2W/Q2W and bimekizumab Q2W/Q4W were combined to bimekizumab Q2W until week 16. The primary end point was HS 50 percent Clinical Response (HiSCR50) at week 16.

The researchers found that more patients receiving bimekizumab than placebo achieved HiSCR50 (BE HEARD I: 47.8 or 45.3 vs 28.7% for bimekizumab Q2W or bimekizumab Q4W versus placebo; BE HEARD II: 52.0 or 53.8 vs 32.2%, respectively). A significantly higher proportion of patients achieved HiSCR75 with bimekizumab vs placebo at week 16 with both dosing regimens in BE HEARD II and with Q2W in BE HEARD I. Across regimens and both studies, responses were maintained to week 48 with bimekizumab for HiSCR50 and HiSCR75. The safety profile of bimekizumab was consistent with previous studies across BE HEARD I and BE HEARD II.

“Treating moderate-to-severe cases with bimekizumab has shown promising results in Phase 3 patient trials, with sustained improvement after one year,” Kimball said in a statement

The study was funded by UCB, the manufacturer of bimekizumab.

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HealthDay News — Adults with atopic dermatitis (AD) have an increased risk for developing melanoma, basal cell carcinoma (BCC), and squamous cell carcinoma (SCC), with significantly higher risks seen for moderate-to-severe versus mild AD, according to a study presented at the annual meeting of the American Academy of Dermatology, held from March 17 to 21 in New Orleans.

Margaret Y. Huang, from the Keck School of Medicine at the University of Southern California in Los Angeles, and colleagues examined the risk for developing melanoma, SCC, and BCC among adults with AD in a retrospective cohort study using a claims database for 2007 to 2021. Data were included for 60 million adults aged 18 years or older with and without a diagnosis of AD who subsequently developed melanoma, SCC, or BCC.

The researchers found that adults with AD had significantly higher risks for developing melanoma, SCC, and BCC compared with those without AD (relative risks 1.23, 1.27, and 1.28, respectively) after adjustment for confounding variables. Adults with moderate-to-severe AD had a significantly higher risk for developing melanoma, SCC, and BCC compared with those with mild AD (relative risks, 1.11, 1.25, and 1.17, respectively).

“In conclusion, our findings support an increased risk of melanoma, SCC, and BCC development in adult patients with AD regardless of AD severity,” the authors write. “More mechanistic studies are necessary to understand AD and the development of skin cancers.”

Abstract

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Accord Healthcare is voluntarily recalling 1 lot of Daptomycin for Injection 500mg/vial, and Daptomycin for Injection 350mg/vial to the consumer level due to a product mix-up.

According to a product complaint report from a hospital pharmacy, vials labeled as “Daptomycin for Injection 500mg/vial” were found in cartons labeled as “Daptomycin for Injection 350mg/vial”. The lot and expiration date on the outer carton and inner vial are the same and correspond to “Daptomycin for Injection 500mg/vial”. 

The recalled lot number of R2200232; Expiration Date 1/2025 for both Daptomycin for Injection 500mg/vial; NDC Number 16729-435-05 and Daptomycin for Injection 350mg/vial; NDC Number 16729-434-05 were distributed nationwide to wholesalers. Daptomycin is indicated for the treatment of susceptible complicated skin and skin structure infections in adults and pediatric patients and Staphylococcus aureus bacteremia in adult patients.

The administration of the affected lot of Daptomycin for Injection 500mg/vial, particularly in children or patients with renal impairment, may lead to a “reasonable probability that the likelihood of the labeled warnings can potentially be increased if a higher than intended dose is used.” At this time, the Company has not received any reports of adverse events related to this recall.

Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.

Reference

Accord Healthcare Inc. issues nationwide voluntary recall of Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial Lot # R2200232 due to product mix-up. News release. Accord Healthcare Inc. December 23, 2022. Accessed December 27, 2022. https://www.prnewswire.com/news-releases/accord-healthcare-inc-issues-nationwide-voluntary-recall-of-daptomycin-for-injection-500-mgvial-and-daptomycin-for-injection-350-mgvial-lot–r2200232-due-to-product-mix-up-301709694.html.

Adalimumab-adbm injection, a biosimilar to Humira^® (adalimumab), has been made available by Boehringer Ingelheim.

Adalimumab-adbm injection is an interchangeable biosimilar and can be substituted for the reference product without requiring a prescription change. The substitution may occur at the pharmacy similar to how generics are substituted for brand name drugs. According to the Company, Adalimumab-adbm injection has been priced at an 81% discount to Humira.  

Adalimumab-adbm injection is indicated for the treatment of adults with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, moderately to severely active Crohn disease, moderately to severely active ulcerative colitis, moderate to severe plaque psoriasis, moderate to severe hidradenitis suppurativa, and noninfectious intermediate, posterior, and panuveitis.

The product is also approved to treat moderately to severely active Crohn disease in children 6 years of age and older, as well as moderately to severely active polyarticular juvenile idiopathic arthritis in children 2 years of age and older.

Adalimumab-adbm injection is a citrate-free formulation and is supplied as 40mg/0.8mL, 20mg/0.4mL and 10mg/0.2mL prefilled syringes and as a 40mg/0.8mL prefilled autoinjector.

In July 2023, Boehringer Ingelheim launched a branded version of adalimumab-adbm called Cyltezo^®. This product will remain available at a 5% discount to Humira.

“Biosimilars are intended to contribute to the economic sustainability of health care systems, and it is our hope that this dual pricing approach will contribute to that sustainability, improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.

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.