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RJ is a 3-year-old girl with dryness, redness, and scaling on her arms. Her mother calls the pharmacy with questions regarding atopic dermatitis (AD). She reports that RJ has been trying to scratch the itchy rash, which appears to be making the plaques thicker. RJ’s mother reports that her daughter has asthma as well. What should the pharmacist recommend to treat AD?

Advise RJ’s mother to limit exposure to all potential triggers for AD, including dyes, excessive bathing, extreme temperatures, irritating detergents and soaps, and tight-fitting clothing. Preventive measures can be implemented to reduce the symptoms of AD. RJ’s clothes and sheets should be thoroughly washed with unscented detergent, and dryer sheets should be avoided. Overall, bathing is recommended to remove bacteria and hydrate the skin, but excessive bathing should be avoided, and lukewarm water and mild, hypoallergenic cleansers should be used. RJ’s skin should be moisturized with unscented emollient products immediately after bathing. The skin barrier can be hydrated and maintained using emollient moisturizers that contain oils, petrolatum, or silicone.

If nonpharmacologic modalities do not provide relief, RJ should be treated with topical corticosteroids, which will suppress the cytokines involved in the inflammatory process. Hydrocortisone 0.5% and 1% topical creams are available over the counter and can be used for AD in ages >2 years. Hydrocortisone should be applied to RJ’s lesions twice daily before the application of her daily moisturizers.

RJ’s mother returns to the pharmacy a few weeks later regarding her daughter’s AD. She mentions that she learned from friends that fish oil and evening primrose oil are helpful for AD. She asks for your input on complementary therapies and evidence for use in AD. What information can you provide to RJ’s mother?

There is little evidence to demonstrate the efficacy of complementary therapies for use in AD. Some studies have shown, however, that phototherapy may be effective in AD after non-pharmacologic measures and topical corticosteroid use do not work. In pediatric patients specifically, ultraviolet A and B phototherapy have demonstrated efficacy and safety for AD. The guidelines now recommend phototherapy as a treatment option for refractory AD.

Other complementary therapies commonly used include borage, coconut, evening primrose, and fish oils. Despite the widespread use of oils for AD, there are insufficient data to support the use of borage, evening primrose, or fish oil. However, some data do support the use of topical coconut oil in AD.

MP is a 7-month-old boy with reddened skin under the diaper area developing over the past 3 days. The area appears wet, but there is no discharge. MP is otherwise healthy and does not appear to have any changes in body temperature, bowel movements, or energy level. His diaper is typically changed frequently, but he has a new nanny who may have a different schedule. What should the pharmacist advise for MP’s condition?

MP’s symptoms are consistent with the common presentation of diaper dermatitis. Given that he does not have diarrhea, fever, or oozing, and he has not had had the rash for > 7 days, he is eligible for treatment at home. Diaper dermatitis can occur in the setting of occlusion from the diaper and increased exposure to moisture from gastrointestinal contents and urine. Instruct MP’s nanny to increase awareness of wet diapers and change them more frequently—a minimum of 6 times per day. A modality that may be difficult but effective includes a “diaper holiday,” where MP would not wear a diaper and therefore avoid duration of contact with a wet diaper.

Additionally, the use of skin protectants with each diaper change will aid in preventing diaper dermatitis. The FDA has approved 17 skin protective ingredients for treatment of diaper dermatitis, including allantoin, calamine, cocoa butter, petrolatum, and zinc oxide. MP’s caregiver should use an OTC skin protectant after each diaper change for 7 days and observe for improvement. If the rash does not improve during that time, a medical referral is recommended. OTC antibacterial and antifungal topical agents are not recommended to treat diaper dermatitis.

PA is a 27-year-old woman who has a rash on her face. She visited the dentist earlier in the day and had a few cavities filled. Immediately following the appointment, PA noted a stinging, swollen rash at the outer corner of her mouth. She researched the material used during a filling and noted that the etching solution used contains phosphoric acid, which could cause contact dermatitis if skin is exposed to it. What advice should the pharmacist provide?

PA should first wash the exposed area with a generous amount of lukewarm water to remove the irritant and reduce skin contact time and exposure. To protect the skin from epidermal water loss, PA should apply copious amounts of petrolatum to the exposed area. In some cases, Burow’s solution (aluminum acetate) can be used for its antibacterial, antiinflammatory, and cooling effects. Unlike with atopic dermatitis, topical corticosteroids do not target the mechanism of irritant contact dermatitis. As such, OTC hydrocortisone would not be an appropriate treatment choice. Likewise, PA should avoid lactic and salicylic acids, propylene glycol, and topical anesthetics, which may cause more irritation and potentiate allergic contact dermatitis. Inform PA that the rash may become hyper- or hypopigmented and scaly. Given that the rash is on her face, the pharmacist should also refer her to a provider for evaluation.

Rupal Patel Mansukhani, PharmD, FAPhA, NCTTP, 

is a clinical associate professor at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, in Piscataway, and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey.

is a clinical assistant professor of pharmacy practice and administration at Ernest Mario School of Pharmacy at Rutgers, The State University of New Jersey, in Piscataway, and an ambulatory care specialist at RWJBarnabas Health Primary Care in Shrewsbury and Eatontown, New Jersey.

1. Paller AS, Simpson EL, Eichenfield LF, Ellis CN, Mancini AJ. Treatment strategies for atopic dermatitis: optimizing the available therapeutic options. 

. 2012;31(suppl 3):S10-S17. doi:10.1016/j.sder.2012.07.004

2. Hon KL, Leung AKC, Barankin B. Barrier repair therapy in atopic dermatitis: an overview. 

 2013;14(5):389-399. doi:10.1007/s40257-013-0033-9

3. Eichenfield LF, Tom WL, Berger TG, et al. Guidelines of care for the management of atopic dermatitis: section 2. Management and treatment of atopic dermatitis with topical therapies. 

 2014;71(1):116-132. doi:10.1016/j.jaad.2014.03.023

4. Sidbury R, Davis DM, Cohen DE, et al. Guidelines of care for the management of atopic dermatitis: section 3. Management and treatment with phototherapy of atopic dermatitis. 

. 2014;71(2):327-349. doi:10.1016/j.jaad.2014.03.030

5. Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: section 4. Prevention of disease flares and use of adjunctive therapies and approaches. 

 2014;71(6):1218-1233. doi:10.1016/j.jaad.2014.08.038

6. Evangelista MTP, Abad-Casintahan F, Lopez-Villafuerte L. The effect of topical virgin coconut oil on SCORAD index, transepidermal water loss, and skin capacitance in mild to moderate pediatric atopic dermatitis: a randomized, double-blind, clinical trial

 2014;53(1):100-108. doi:10.1111/ijd.12339

7. Stamatas GN, Tierney NK. Diaper dermatitis: etiology, manifestations, prevention, and management.

 L, Stamatas GN, Kottner J, Garcia Bartels N. Prevention of diaper dermatitis in infants—a literature review. 

 2014;31(4):413-429. doi:10.1111/pde.12348

9. Food and Drug Administration, HHS. Skin protectant drug products for over-the-counter human use; final monograph. Final rule. 

10. Eberting CL, Blickenstaff N, Goldenberg A. Pathophysiologic treatment approach to irritant contact dermatitis. 

11. Corazza M, Minghetti S, Bianchi A, Virigili A, Borghi A. Barrier creams: facts and controversies. 

. 2014;25(6):327-333. doi:10.1097/DER.0000000000000078

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How would you respond to these patients' concerns?

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OTC Case Studies: Dermatitis

 interviewed Ken Perez, MBA, vice president of healthcare policy and government affairs at Omnicell, on the House and Senate bills, HR2759 and S1362 respectively, intended to grant pharmacists provider status for Medicare Part B.

In this discussion, Perez describes how the role of a pharmacist would change if this legislation passes. He emphasizes that much of what would be expected of pharmacists are services they already provide, and that this legislation would incentivize them to practice at the top of their license.

Videos

Ken Perez, MBA, vice president of healthcare policy and government affairs at Omnicell, discussed the changes that would take place if pharmacists were granted provider status for Medicare Part B.

The Effect of Provider Status Legislation on the Role of a Pharmacist

 encompass a broad spectrum of diseases affecting skin and underlying subcutaneous tissue, fascia, or muscle that can range in severity from mild to life threatening.

Clinical trials using this terminology leave some ambiguity in interpretation because of the use of heterogeneous, broad inclusion criteria attributed to a lack of standardized nomenclature and monitoring parameters.

 To provide consistency in the identification of infections for which a treatment effect can be reliably estimated, in October 2013 the FDA released a guidance document that introduced the term 

acute bacterial skin and skin structure infections

 (ABSSSI) and defined quantifiable efficacy end points.

ABSSSI include cellulitis/erysipelas, wound infections, and major cutaneous abscesses with a lesion surface area of equal to or greater than 75 cm

, measured by the area of edema, induration, or redness.

 Excluded from the definition are some skin and skin structure infections of very mild severity, very high severity, or those appearing from specific causes or in specific hosts. Such conditions include animal or human bites, burn wounds, chronic wound or diabetic food infections, ecthyma gangrenosum, impetigo, minor cutaneous abscesses, myonecrosis, and necrotizing fasciitis.

Suboptimal treatment of ABSSSI, resulting from failure to recognize risk factors, misclassification of severity, misdiagnosis, or using the wrong duration or type of antibiotics, may lead to infection recurrence and/or treatment failure.

This review summarizes the treatment of ABSSSI by focusing on typical pathogens expected, based on severity classification and patient risk factors, and provides associated recommendations for treatment.

Pathogens that should be suspected in various ABSSSI depend on the severity classification and patient risk factors. Abscesses and cellulitis/erysipelas are typically caused by gram-positive bacteria. However, other pathogens can be encountered depending on the location of infection and other risk factors.

 The presence of purulence typically indicates a high probability that 

, as opposed to a streptococcal spp, may be involved. In wound infections, the anatomical location of the wound plays a significant role in determining the microbiologic differential.

 For example, gram-negative organisms are typically seen in wound infections of the lower or perianal abdominal area, whereas methicillin-resistant 

 (MSSA) are more predominant in wound infections following surgery of the extremities, head, neck, or trunk.

The guideline-recommended empiric antibiotic regimens differ for nonpurulent and purulent infections, because of known differences in causative pathogens. For purulent infections, empiric oral antibiotic regimens for mild or moderate disease include oral agents with activity against 

, including MRSA and MSSA, such as doxycycline or trimethoprim-sulfamethoxazole.

 For patients with moderate or severe purulent infections requiring inpatient admission, intravenous (IV) agents include ceftaroline, daptomycin, linezolid, or vancomycin, with vancomycin representing the typical first-line agent.

 As in all infectious syndromes, special care should be given to the appropriate stewardship of antimicrobial agents when making therapy selections.

Empiric antibiotic regimens for nonpurulent cellulitis and erysipelas should primarily target streptococcal spp given the predominance of this organism in the syndrome. For outpatient management of mild or moderate infections, optimal agents include either oral first-generation cephalosporins (ie, cefadroxil or cephalexin) or a penicillin (ie, amoxicillin or penicillin). Clindamycin can be used for patients with known, severe β-lactam allergy.

For inpatient management of mild or moderate infections, the optimal first-line IV option is a first-generation cephalosporin, such as cefazolin, although such other agents as ceftriaxone, nafcillin, or penicillin also provide an appropriate empiric spectrum of activity. Clindamycin or vancomycin can be used in patients unable to tolerate β-lactams.

Patients with nonpurulent disease who have a history of MRSA infections should be considered for empiric treatment with vancomycin or another agent that will cover MRSA.

As previously indicated, treatment of wound infections varies based on the anatomical location of the wound and expected flora at the wound site. In general, oral antimicrobial regimens should include antistreptococcal agents, such as cephalexin, and anti-MRSA agents, such as trimethoprim-sulfamethoxazole. IV vancomycin provides appropriate coverage of gram-positive organisms for patients admitted to the hospital.

 Infected wounds of the abdominal, perianal, or urogenital regions should include empiric coverage for enteric anaerobes and gram-negative pathogens.

 Empiric oral regimens include amoxicillin-clavulanate or cefdinir and metronidazole. A preferred empiric IV regimen for abdominal, perineal, or urogenital wound infection consists of ceftriaxone and metronidazole.

In attempts to reduce the risk for unintended consequences of antimicrobial use, significant focus has been applied to reducing the duration of antibiotic treatment for many infections, including ABSSSI. Studies continue to emerge showing that shorter courses of antibiotics for cellulitis are just as efficacious as longer durations.

 In 1 such study of patients receiving antibiotic therapy for uncomplicated cellulitis, the results showed no significant differences in the clinical outcomes or treatment failure in those who received 5 days of therapy compared with patients receiving 10 days.

 As such, the most recent guidelines for ABSSSI recommend a duration of 5 days of antibiotic therapy. However, for those who demonstrate delayed clinical improvement (ie, delayed resolution of fever, recession of erythema, or vital sign stability), it may be necessary to extend the antimicrobial duration.

ABSSSI are commonly encountered in clinical practice. The broad scope of patient risk factors, severity of illness, and syndromes can be intimidating factors in determining suspected microbiology, empiric antimicrobial selection, and therapy duration. Key elements involved in these facets of care include the absence or presence of purulence, anatomical location, need for inpatient care or IV antimicrobials, and severity of infection. Careful consideration of these key factors will guide clinicians in their care of patients presenting with ABSSSI (see Table

is an inpatient antimicrobial stewardship pharmacist at Ascension Sacred Heart Hospital in Pensacola, Florida.

is an antimicrobial stewardship/outpatient antimicrobial therapy pharmacist at Mayo Clinic in Rochester, Minnesota.

is a PGY-2 emergency medicine pharmacy resident at Mayo Clinic.

1. Pollack CV Jr, Amin A, Ford WT Jr, et al. Acute bacterial skin and skin structure infections (ABSSSI): practice guidelines for management and care transitions in the emergency department and hospital. 

 2015;48(4):508-519. doi:10.1016/j.jemermed.2014.12.001

2. Tiwari AK, Lal R. Study to evaluate the role of severity stratification of skin and soft tissue infections (SSTIs) in formulating treatment strategies and predicting poor prognostic factors. 

 2014;12(2):125-133. doi:10.1016/j.ijsu.2013.11.014

3. Russo A, Concia E, Cristini F, et al. Current and future trends in antibiotic therapy of acute bacterial skin and skin-structure infections. 

2016;22(suppl 2):S27-36.doi:10.1016/S1198-743X(16)30095-7

4. Acute bacterial skin and skin structure infections: developing drugs for treatment. FDA. October 2013. Accessed June 18, 2021. https://www.fda.gov/files/drugs/published/Acute-Bacterial-Skin-and-Skin-Structure-Infections---Developing-Drugs-for-Treatment.pdf

5. Pulido-Cejudo A, Guzmán-Gutierrez M, Jalife-Montaño A, et al. Management of acute bacterial skin and skin structure infections with a focus on patients at high risk of treatment failure. 

2017;4(5):143-161. doi:10.1177/2049936117723228

6. Stevens DL, Bisno AL, Chambers HF, et al; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. 

 2014;59(2):e10-e52. doi:10.1093/cid/ciu444

7. Sartelli M, Guirao X, Hardcastle TC, et al. 2018 WSES/SIS-E consensus conference: recommendations for the management of skin and soft-tissue infections. 

2018;13:58. doi:10.1186/s13017-018-0219-9

8. Mazuski JE, Tessier JM, May AK, et al. The Surgical Infection Society revised guidelines on the management of intra-abdominal infection. 

2017;18(1):1-76. doi:10.1089/sur.2016.261

9. Spellberg B. The new antibiotic mantra—“shorter is better.” 

. 2016;176(9):1254-1255. doi:10.1001/jamainternmed.2016.3646

10. Prokocimer P, De Anda C, Fang E, Mehra P, Das A. Tedizolid phosphate vs linezolid for treatment of acute bacterial skin and skin-structure infections: the ESTABLISH-1 randomized trial. 

. 2013;309(6):559-569. doi:10.1001/jama.2013.241

11. Moran GJ, Fang E, Corey GR, Das AF, De Anda C, Prokocimer P. Tedizolid for 6 days versus linezolid for 10 days for acute bacterial skin and skin-structure infections (ESTABLISH-2): a randomised, double-blind, phase 3, non-inferiority trial. 

 2014;14(8):696-705. doi:10.1016/S1473-3099(14)70737-6

12. Hepburn MJ, Dooley DP, Skidmore PJ, Ellis MW, Starnes WF, Hasewinkle WC. Comparison of short course (5 days) and standard (10 days) treatment for uncomplicated cellulitis. 

2004;164(15):1669-1674. doi:10.1001/archinte.164.15.1669

13. Kannangara DW, Pandya D. Infections in injection drug users: the significance of oral bacteria and a comparison with bacteria originating from skin and environmental sources. 

 January 22, 2020. Accessed June 18, 2021. 

https://www.researchgate.net/publication/338836628_Infections_in_Injection_Drug_Users_The_Significance_of_Oral_Bacteria_and_a_Comparison_with_Bacteria_Originating_from_Skin_and_Environmental_Sources

14. Jenkins TC, Knepper BC, Moore SJ, et al. Microbiology and initial antibiotic therapy for injection drug users and non-injection drug users with cutaneous abscesses in the era of community-associated methicillin-resistant Staphylococcus aureus. 

2015;22(8):993-997. doi:10.1111/acem.12727

Consider key elements of acute bacterial skin and skin structure infection to help patients manage this broad range of diseases.

Hospital

Scratch Beneath the Surface: ABSSSI

A new survey conducted by The Harris Poll on behalf of the Samueli Foundation found that 29% of Americans are taking more supplements compared with before the COVID-19 pandemic, bringing the nationwide percentage of supplement-takers to 76%.

The results showed that nearly two-thirds of those who increased supplement use (65%) cited a desire to enhance their overall immunity (57%) or protection from COVID-19 (36%) as reasons for the spike. Other reasons for the increase included taking control of their own health (42%), improving sleep (41%), and improving their mental health (34%).

"The COVID-19 pandemic is a catalyst for increased supplement use," said Wayne Jonas, MD, executive director of Integrative Health Programs at Samueli Foundation, in a press release. "Supplements, when used under the guidance of health care professionals, can be beneficial for one's health. Unfortunately, however, many people are unaware of the risks and safety issues associated with their use."

Additional results showed that more than half of those surveyed taking supplements (52%) mistakenly believe that most dietary supplements available for purchase have been declared safe and effective by the FDA. Approximately 32% indicated that if a supplement could be dangerous, it would not be allowed to be sold in the United States.

"Contrary to what many believe, the FDA does not regulate supplements. In fact, many supplements are not identified as dangerous until after people are negatively affected by them,” Jonas said in the press release. "There are benefits to one's health from supplements, but also risks, so I encourage anyone who is taking a supplement or thinking of taking one to discuss it with your health care provider first."

Less than half of Americans who use supplements (47%) said they spoke with a health care provider before use, despite national guidelines that strongly recommend doing so. Further, 46% of Americans currently taking prescription medications said they have not talked to their health care provider about the possible interactions that supplements could have with their prescriptions.

There were various barriers analyzed in terms of discussing supplements with a health care provider, including:

Thirty five percent of all Americans claim they do not think their health care provider is interested in whether they are taking supplements.

Approximately 32% of Americans do not think their health care provider knows enough about supplements to advise them properly.

Other findings showed differences that are based on race and ethnicity, such as:

Only 86% of non-Hispanic Americans said they would be comfortable sharing which supplements they take with their health care provider compared to 67% of Hispanics and 75% of Blacks.

More than 1 in 3 Hispanic adults said they worry that their health care provider will make preconceived judgements based on the supplements they take, whereas 46% said they do not think their health care provider is interested versus 31% of non-Hispanic adults.

The survey was conducted online among 2053 US adults ages 18 years and older, including 1531 who are currently taking supplements. The participants were surveyed from June 15-17, 2021.

Three in ten Americans increased supplement use since onset of pandemic. EurekAlert! July 21, 2021. Accessed July 21, 2021. 

https://www.eurekalert.org/pub_releases/2021-07/trg-tit072021.php

Vitamins and Supplements

Survey Finds 3 in 10 Americans Increased Supplement Use Since COVID-19 Pandemic

New research from Lehigh University has found that students with attention-deficit hyperactivity disorder (ADHD) face substantial challenges in succeeding and completing their college education. A new paper by George DePaul, professor of school psychology and associate dean for research in Lehigh University’s College of Education, hypothesizes ways academic success can improve.

The paper, called “Academic Trajectories of College Students with and without ADHD: Predictors of Four-Year Outcomes,” highlights one of the largest, most comprehensive investigations of college students with ADHD conducted and is the first to systematically examine the functioning of ADHD students across 4 years of college.

“College students with ADHD are likely to experience significant academic difficulties throughout their college years, are at higher than average risk for dropping out of college and require academic support prior to and throughout their college years,” DuPaul said in a press release.

More than 400 college students were assessed through annual psychological and educational evaluations, half of whom identified with ADHD, including multiple academic outcomes including GPA by semester, progress toward graduation by academic year, self-reported study skills by academic year, and college drop-out status. The study took place over the course of 4 years with student participants from colleges in North Carolina, Pennsylvania, and Rhode Island.

The findings showed that on average, college students with ADHD received grades that were half a grade level below their peers in all 4 years. In addition, the results showed that college students with ADHD were significantly less likely to stay enrolled across semesters.

“It was somewhat surprising to see the magnitude of the academic deficits experienced by college students with ADHD because these were students who had the skills to successfully graduate from high school and matriculate in a four-year college or university,” DuPaul said in the press release. “We expected smaller declines in their educational performance in college.”

There were several variables that helped project academic success for students with ADHD, including having fewer depression symptoms, retaining better executive functioning skills such as planning and time management, and having received educational accommodations in high school and academic support services in college, according to the researchers.

The study authors hope that the findings will spark interest to college disability offices, health care and mental health professionals who work with college-aged students, higher education faculty and administrators, and individuals with ADHD and their families.

“Our findings highlight the importance of providing academic support services for students with ADHD prior to college matriculation, the vital need to improve executive functioning skills in these students, and necessity to screen for and treat depressive symptoms experienced by college students with ADHD,” DuPaul said in the press release.

Researchers find college students with ADHD are likely to experience significant academic challenges. Lehigh University. February 22, 2021. Accessed July 20, 2021. 

https://www2.lehigh.edu/news/researchers-find-college-students-with-adhd-are-likely-to-experience-significant-academic

The findings showed that on average, college students with ADHD received grades that were half a grade level below their peers in all 4 years.

ADHD

College Students With ADHD More Likely to Experience Significant Academic Challenges

The FDA has granted Orphan Drug Designation (ODD) to alrizomadlin (APG-115, Ascentage Pharma) for the treatment of stage IIB-IV melanoma. This marks the fifth ODD granted to the drug, in addition to designations for the treatment of gastric cancer, acute myeloid leukemia, soft tissue sarcoma, and retinoblastoma, according to a press release.

Significant progress has been achieved in recent years in the clinical treatment of patients with metastatic or unresectable melanoma, with therapies such as mitogen-activated protein kinase inhibitors and immunotherapies to help improve patients’ overall survival and quality of life. Although immunotherapies have been studied and used broadly in treatment, a significant number of patients will eventually develop resistance to immune checkpoint inhibitors (ICIs), which does not have an approved treatment for patients with ICI-resistant melanoma.

Alrizomadlin is an orally administered, selective MDM2-p53 inhibitor that, when combined with a PD-1 blockade, enhances antitumor activities by triggering adaptive antitumor immunity. A cohort of patients with PD-1/PD-L1 inhibitor-resistant melanoma treated with alrizomadlin plus pembrolizumab had 1 patient achieve a complete response, an objective response rate of 24.1%, and a disease control rate of 55.2%.

These findings showed the interaction between alrizomadlin and immune-oncologic drugs, and a potential regimen that could provide hope to patients with ICI-resistant melanoma, according to the press release.

"At present, there is a large unmet medical need for the treatment of melanoma. Therefore, this ODD for alrizomadlin bears tremendous significance," said Yifan Zhai, MD, chief medical officer of Ascentage Pharma, in a press release. “The FDA's supporting policy for orphan drug development will help us to further accelerate the clinical development of alrizomadlin and other drug candidates in our pipeline and hopefully we can bring these potential novel therapies to patients as soon as possible."

Ascentage Pharma's MDM2-p53 Inhibitor APG-115 (Alrizomadlin) Granted an Orphan Drug Designation by the FDA for the Treatment of Stage IIB-IV Melanoma, Marking the Twelfth Obtained by the Company. July 21,2021. Accessed July 22, 2021. 

https://www.prnewswire.com/news-releases/ascentage-pharmas-mdm2-p53-inhibitor-apg-115-alrizomadlin-granted-an-orphan-drug-designation-by-the-fda-for-the-treatment-of-stage-iib-iv-melanoma-marking-the-twelfth-obtained-by-the-company-301338428.html

The FDA has granted Orphan Drug Designation (ODD) to alrizomadlin (APG-115, Ascentage Pharma) for the treatment of stage IIB-IV melanoma.

Oncology

Specialty Pharmacy

Skin Cancer

FDA Grants Orphan Drug Designation to Alrizomadlin for Stage IIB-IV Melanoma

A review in the July/August issue of the 

 found that there is currently limited research showing whether cannabis has additional adverse effects on brain development or functioning in adolescents or young adults with attention-deficit hyperactivity disorder (ADHD).

"[T]he evidence to date does not clearly support either an addictive effect or an interaction – whether protective or harmful with cannabis use," said study author Philip B. Cawkwell, MD, of Stanford University School of Medicine, in a press release.

Cawkwell and his colleagues emphasized the need for further research to clarify the possible effects of cannabis on brain structure, function, and behavior in young people with ADHD.

The team performed a systematic review of research on the combined effects of cannabis use and ADHD in adolescence. The search identified 11 studies assessing any type of neurodevelopmental outcome in adolescents or young adults with ADHD who used cannabis compared with those who did not use cannabis.

There were some significant differences shown in the 7 studies assessing neuroimaging findings for young patients with ADHD in brain structure among cannabis users, according to the researchers. The findings included decreased thickness in areas involved with motor and sensory function and increased thickness in areas involved in the brain’s “reward” system. There were limitations of the study, which the authors noted because they said it was impossible to determine whether these findings reflect causal relationships.

Further, functional imaging studies reported differences in cannabis users with ADHD and in performance on standardized tasks and reduced density of dopamine transporters. This affects the availability of dopamine, which plays a critical role in the reward system, according to the study authors.

Four of the studies examined the results of neuropsychological tests or questionnaires in young people with ADHD who did and did not use cannabis, since its use was associated with impaired performance on tests of sustained attention. However, neither of these studies found a significant interaction between ADHD and cannabis use.

"Surprisingly, as cannabis use demonstrates clear and consistent adverse effects on cognition as measured by neuropsychological task performance, no study identified a significant differential impact of cannabis use on these measures for individuals with ADHD compared to non-users," Cawkwell said in the press release. “However, this lack of interaction may just be due to the limited number of studies to date, rather than a true lack of impact.”

A key limitation to the research were the number of studies and the overall number of participants, in addition to the findings that suggest differences in the effects of cannabis use at earlier ages, which is a major gap for researchers. Additional factors needing further analysis include potency of cannabis and frequency of use.

"[T]his important study may begin to provide answers to some of the questions that this paper has shown to be unanswered – including understanding whether cannabis does truly alter neural circuitry in youth with ADHD, how this impacts task performance, and perhaps most critically, the longer-term functional outcomes for adolescents with ADHD who also use cannabis,” Cawkwell said in the press release.

Does cannabis affect brain development in young people with ADHD? Too soon to tell, reports Harvard Review of Psychiatry. Wolters Kluwer. July 2, 2021. Accessed July 19, 2021. 

https://www.wolterskluwer.com/en/news/does-cannabis-affect-brain-development-in-young-people-with-adhd

Study: Too Soon to Tell Whether Cannabis Affects Brain Development in Young People With ADHD

Investigators have found that a small percentage of epidermal growth factor receptor (EGFR) inhibitor-resistant cancer cells are present in certain patients with non-small cell lung cancers (NSCLCs), potentially explaining tumor regrowth in these patients, according to a study published in 

. Mutations in the EGFR growth receptor occur in approximately 15% of NSCLCs, according to the study.

The study results indicate that these drug-resistant cells rely on a different gene—

—for survival instead of EGFR. The investigators further observed that cancer cells could transition between drug-sensitive and drug-resistant states, and that when patients finish EGFR treatment, random modifications constantly occur in the remaining cells, which causes both types of cells to grow back.

Gregory Hannon, FRS, FMedSci, one of the study’s investigators, conducts research mainly focused on microRNA, a molecule that regulates cells by managing transcribed genes. The investigators found that a specific mircoRNA—miR335—determines the state of the cancer cell.

If miR335 is lost, the cell undergoes a cascade of events leading to the use of the 

 pathway, and these cells are no longer killed by drugs targeting EGFR. These drug-resistant cells are able to survive treatment with EGFR inhibitors, allowing the tumor to eventually grow back, according to the researchers.

“The genome is like a library,” said Raffaella Sordella, PhD, in a press release. “So, when you have to do a recipe to bake something, you go there, you transcribe your recipe, you take it out from the library, you go in the kitchen. What these microRNAs do, they intercept all the recipes that are getting out from your library. And then, they decide whether this is a recipe that the cell should care about or not. So, they are what they call 'gatekeepers' of a cell state.”

According to the study authors, understanding the mechanisms by which drug resistance arises in lung cancer is critical to determining how to eliminate a tumor. They expressed hope that these findings would allow further research to develop treatments that can target both 

dependent cells from the start, potentially preventing tumor regrowth entirely.

Preventing lung cancer's unwelcome return [news release]. ScienceDaily; July 13, 2021. Accessed July 22, 2021. 

https://www.sciencedaily.com/releases/2021/07/210713145827.htm

Investigators have found that a small percentage of epidermal growth factor receptor (EGFR) inhibitor-resistant cancer cells are present in certain patients with non-small cell lung cancers (NSCLCs), potentially explaining tumor regrowth in these patients.

Lung Cancer

MicroRNA, AXL Gene Potentially Responsible for Drug Resistance in Certain Non-Small Cell Lung Cancers

Despite the controversy surrounding the FDA approval of aducanumab for patients with Alzheimer disease, Pamela Spicer, senior analyst at Datamonitor with Informa Pharma Intelligence, said this is "a huge accomplishment."

Because there are no other available treatment options, Spicer said the approval of aducanumab gives much-needed hope to patients with Alzheimer disease and their families. She added that other investigational drugs for Alzheimer disease could have encouraging results in the future, but this approval offers a more immediate treatment option.

Because there are no other available treatment options, Pamela Spicer said the approval of aducanumab gives much-needed hope to patients with Alzheimer disease and their families. 

Neurology

Expert: Approval of Aducanumab for Alzheimer Disease 'Is a Huge Accomplishment'

The Affordable Care Act (ACA) resulted in fewer financial barriers to health care for cancer survivors between 18 and 64 years of age, according to a study published in 

. The investigators said the ACA helped lower the financial burden for younger cancer survivors to its lowest estimated levels in 20 years.

The study analyzed data gathered from more than 20,000 Americans who responded to the National Health Interview Survey, a series of interviews conducted by a part of the CDC that collects data on a broad number of health care topics, including chronic conditions and vaccinations. The investigators found that younger cancer survivors were less likely to delay treatment due to cost and had less trouble paying for medications and dental care between 2014 and 2018. This 5-year period is the timeframe in which certain key features of the ACA went into effect, including the Health Insurance Marketplace, which allowed individuals, families, and small businesses to compare and purchase health insurance plans.

“There has been a lot of talk about the ACA affecting people who don't have the Medicare safety net,” said Christopher Su, MD, a clinical fellow in the division of hematology and oncology at Michigan Medicine, in a press release. “We were able to drill down to that and show that it did make a difference to younger cancer survivors.”

In contrast, cancer survivors 65 years of age and older experienced little change in their ability to afford health care after the ACA went into effect. According to the study authors, this is likely because so many of these patients were on Medicare.

The investigators then traced these metrics backwards over the past 2 decades. They found that between 2015 and 2017, younger cancer survivors were more likely to be able to afford their health care than they were at any time since 1999. Additionally, the number of younger cancer survivors who were uninsured dropped and Medicaid enrollment increased for this group after the ACA became law.

“The younger working population doesn't have pensions,” Su said in the release. “Most don't have a rainy-day fund stored away for them if they get cancer. They're still trying to work, still trying to put bread on the table. But the ACA made it easier to sign up for Medicaid, to sign up for a health insurance plan that's affordable to them, and now they have a better umbrella to fall back on for their health care expenses without jeopardizing their already precarious finances because cancer put them out of work or reduced the time that they could be working.”

Financial barriers fell for some cancer survivors after Affordable Care Act [news release]. EurekAlert; July 13, 2021. Accessed July 19, 2021. 

https://new.eurekalert.org/pub_releases/2021-07/mm-u-fbf070921.php

The investigators said the ACA helped lower the financial burden for younger cancer survivors to its lowest estimated levels in 20 years.

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