Selection of Nemolizumab Clinical Dosage for Atopic Dermatitis.

Nemolizumab is a monoclonal antibody directed against the interleukin-31 receptor A subunit, which is involved in the pathogenesis of pruritus and inflammation in atopic dermatitis (AD). Clinical trial results were combined with population PK (popPK) and pharmacokinetic/ pharmacodynamic (PK/PD) models to optimize nemolizumab dosing. Phase 1 and 2a clinical studies indicated that weight-based nemolizumab dosing reduced pruritus in patients with moderate-to-severe AD with good safety and tolerability even at the highest dose (3 mg/kg single dose and 2 mg/kg multiple doses). Nemolizumab PK profile was characterized by a slow absorption with peak serum concentrations reached 4.5-9.2 days post-dose, and a long terminal half-life ranging from 12.6 to 16.5 days. A change from weight-based dosing to flat dose was supported by an additional phase 2b study sponsored by Galderma. Flat dosing provides several practical advantages, including ease of preparation for self- or auto-injection and reduced chance of dosing errors. Doses of 10, 30, and 90 mg were selected based on popPK and PK/PD simulations to result in nemolizumab serum concentrations sufficient to achieve efficacy. Loading doses were administrated at the 2 lower doses in order to achieve target systemic concentrations from the first injection. The efficacy of Nemolizumab in improving cutaneous signs of inflammation and pruritus in AD and its safety profile, combined with popPK and PK/PD analyses, supported selection of the flat-dose regimen of 30 mg (with a 60 mg loading dose) given every 4 weeks subcutaneously for 16 weeks in the phase 3 ARCADIA studies sponsored by Galderma. J Drugs Dermatol. 2023;22(10):1017-1020 doi:10.36849/JDD.7437R1.

Aromatherapy, botanicals, and essential oils in acne.

Complementary and alternative medicine approaches are popular among some patient segments due to the perception that they are "natural" and thus are believed to be less likely to be dangerous, to be less toxic, or to cause fewer side effects. In dermatology, these can include aromatherapy, botanicals, and essential oils (plant extracts). Preliminary evidence, biological activity studies, and small pilot clinical trials conducted outside of North America, mostly in young adults, suggest that some may have value in acne treatment. When additional research and larger clinical trials are conducted, both clinicians and patients will be able to understand the risks and benefits compared with allopathic remedies.

Improved clinical outcome and biomarkers in adults with papulopustular rosacea treated with doxycycline modified-release capsules in a randomized trial.

BACKGROUND: Patients with rosacea have increased amounts of cathelicidin and protease activity but their usefulness as disease biomarkers is unclear. OBJECTIVE: We sought to evaluate the effect of doxycycline treatment on cathelicidin expression, protease activity, and clinical response in rosacea. METHODS: In all, 170 adults with papulopustular rosacea were treated for 12 weeks with doxycycline 40-mg modified-release capsules or placebo in a multicenter, randomized, double-blind, placebo-controlled study. Clinical response was compared with cathelicidin and protease activity in stratum corneum samples obtained by tape strip and in skin biopsy specimens obtained from a random subset of patients. RESULTS: Treatment with doxycycline significantly reduced inflammatory lesions and improved investigator global assessment scores compared with placebo. Cathelicidin expression and protein levels decreased over the course of 12 weeks in patients treated with doxycycline. Low levels of protease activity and cathelicidin expression at 12 weeks correlated with treatment success. Low protease activity at baseline was a predictor of clinical response in the doxycycline treatment group. LIMITATIONS: Healthy control subjects were not studied. CONCLUSIONS: Improved clinical outcome correlated with reduced cathelicidin and protease activity, supporting both the mechanism of doxycycline and the potential of these molecules as biomarkers for rosacea.

The use of a reliable, ubiquitous, inexpensive, and user-friendly tablet-based system to track target lesion improvements in subjects with plaque psoriasis treated with clobetasol propionate 0.05% spray.

Ubiquitous electronic devices, such as smartphones and tablets, have the potential to enable a fundamental shift in the paradigm of healthcare as these devices may allow patients and health care providers (HCPs) to rapidly and remotely communicate with each other. Once fully realized, these devices may facilitate interactions between patients and HCPs. While these devices hold much promise, much work remains in assessing their viability in various diseases. A pilot study was conducted to investigate the use of a tablet-based numeric rating scale to assess improvements in a plaque psoriasis target lesion treated with clobetasol propionate 0.05% spray (CPS). Twenty-eight subjects with plaque psoriasis enrolled and were treated with CPS twice daily for 15 days. Target lesion severity (scale of 0 [no psoriasis] to 10 [very severe psoriasis]) and effectiveness scores (scale of 0 [none] to 3 [severe]) were recorded using a tablet-based system by the investigator and subjects. The tablet was also used to take photos of the target lesion to capture photographic evidence of improvement. Investigator and subject assessed target lesion severity and effectiveness scores improved during the study from baseline to day 15; in addition subjects indicated a high level of satisfaction with CPS treatment. Very few technological failures were reported and captured photographs were consistent visit to visit and of high quality. Taken together, this study supports the use of a tablet-based system to measure and track plaque psoriasis disease progression and also confirmed that CPS is an effective and safe treatment for plaque psoriasis.

Efficacy, safety, and subject satisfaction of a specified skin care regimen to cleanse, medicate, moisturize, and protect the skin of patients under treatment for acne vulgaris.

Optimal management of acne vulgaris requires incorporation of several components including patient education, selection of a rational therapeutic regimen, dedicated adherence with the program by the patient, and integration of proper skin care. Unfortunately, the latter component is often overlooked or not emphasized strongly enough to the patient. Proper skin care may reduce potential irritation that can be associated with topical acne medications and prevents the patient from unknowingly using skin care products that can actually sabotage their treatment. This article reviews the effectiveness, skin tolerability, safety, and patient satisfaction of an open label study in which a specified skin care regimen is used in combination with topical therapy. The study was designed to mirror "real world" management of facial acne vulgaris clinical practice. The skin care regimen used in this study included a brand foam wash and a brand moisturizer with SPF 30 photoprotection, both of which contain ingredients that are included to provide benefits for acne-prone and acne-affected skin.

Predicting improvement in signs and symptoms of plaque psoriasis after 1 week of treatment with clobetasol propionate 0.05% spray.

One of the hurdles to effectively managing plaque psoriasis is lack of adherence to prescribed treatments. Up to 40% of subjects report they do not adhere to their medication for a variety of reasons. Earlier response to treatment may be a motivator for subjects to better adhere to treatment. Clobetasol propionate 0.05% spray (CPS) is a highly potent topical corticosteroid indicated for the treatment of moderate to severe plaque psoriasis that has efficacy as early as 1 week after initiating therapy. Using data from the 2 CPS pivotal trials, a post hoc analysis was performed to determine the relationship between week 1 improvements and week 4 treatment success (defined as a score of 0 [clear] or 1 [almost clear] in overall disease severity [ODS]). Improvements in week 1 ODS and pruritus were predictive of week 4 treatment success. Subjects who had ODS or pruritus scores of moderate or better at week 1 tended to be treatment successes at week 4 whereas no relationship between week 1 scores and week 4 treatment success was observed for those treated with vehicle spray. The results of this post hoc analysis indicate that early improvement correlates to treatment success.

Power is only skin deep: an institutional ethnography of nurse-driven outpatient psoriasis treatment in the era of clinic web sites.

We present an institutional ethnography of hospital-based psoriasis day treatment in the context of evaluating readiness to supplement services and support with a new web site. Through observation, interviews and a critical consideration of documents, forms and other textually-mediated discourses in the day-to-day work of nurses and physicians, we come to understand how the historical gender-determined power structure of nurses and physicians impacts nurses' work. On the one hand, nurses' work can have certain social benefits that would usually be considered untenable in traditional healthcare: nurses as primary decision-makers, nurses as experts in the treatment of disease, physicians as secondary consultants, and patients as co-facilitators in care delivery processes. However, benefits seem to have come at the nurses' expense, as they are required to maintain a cloak of invisibility for themselves and for their workplace, so that the Centre appears like all other outpatient clinics, and the nurses do not enjoy appropriate economic recognition. Implications for this negotiated invisibility on the implementation of new information systems in healthcare are discussed.

Patient-perceived usefulness of online electronic medical records: employing grounded theory in the development of information and communication technologies for use by patients living with chronic illness.

OBJECTIVE: Patient use of online electronic medical records (EMR) holds the potential to improve health outcomes. The purpose of this study is to discover how patients living with chronic inflammatory bowel disease (IBD) value Internet-based patient access to electronic patient records. DESIGN: This was a qualitative, exploratory, descriptive study using in-depth interviews and focus groups of a total of 12 patients with IBD of at least one-year duration at University Health Network, a tertiary care center in Toronto, Ontario. RESULTS: Four themes have been elucidated that comprise a theoretical framework of patient-perceived information and communication technology usefulness: promotion of a sense of illness ownership, of patient-driven communication, of personalized support, and of mutual trust. CONCLUSIONS: For patients with chronic IBD, simply providing access to electronic medical records has little usefulness on its own. Useful technology for patients with IBD is multifaceted, self-care promoting, and integrated into the patient's already existing health and psychosocial support infrastructure. The four identified themes can serve as focal points for the evaluation of information technology designed for patient use, thus providing a patient-centered framework for developers seeking to adapt existing EMR systems to patient access and use for the purposes of improving health care quality and health outcomes. Further studies in other populations are needed to enhance generalizability of the emergent theory.

Overcoming structural constraints to patient utilization of electronic medical records: a critical review and proposal for an evaluation framework.

There are constraints embedded in medical record structure that limit use by patients in self-directed disease management. Through systematic review of the literature from a critical perspective, four characteristics that either enhance or mitigate the influence of medical record structure on patient utilization of an electronic patient record (EPR) system have been identified: environmental pressures, physician centeredness, collaborative organizational culture, and patient centeredness. An evaluation framework is proposed for use when considering adaptation of existing EPR systems for online patient access. Exemplars of patient-accessible EPR systems from the literature are evaluated utilizing the framework. From this study, it appears that traditional information system research and development methods may not wholly capture many pertinent social issues that arise when expanding access of EPR systems to patients. Critically rooted methods such as action research can directly inform development strategies so that these systems may positively influence health outcomes.

Provider-sponsored virtual communities for chronic patients: improving health outcomes through organizational patient-centred knowledge management.

Patients with long-term chronic disease experience numerous illness patterns and disease trends over time, resulting in different sets of knowledge needs than patients who intermittently seek medical care for acute or short-term problems. Health-care organizations can promote knowledge creation and utilization by chronic patients through the introduction of a virtual, private, disease-specific patient community. This virtual socialization alters the role of chronic disease patients from external consumers of health-care services to a 'community of practice' of internal customers so that, with the tacit support of their health-care organization, they have a forum supporting the integration of knowledge gained from the experiences of living with chronic disease in their self-management. Patient-centred health-care organizations can employ the virtual community to direct and support the empowerment of chronic patients in their care.