Healthcare Professional Use and Attitudes Regarding Oral Antibiotics Treaters included 29 board-certified dermatologists and one nurse practitioner from private community dermatology practices; 60% of the clinicians reported frequently prescribing broad-spectrum antibiotics; 66.7% were moderately/extremely concerned about antibiotic resistance; and 63.3% were moderately/extremely concerned about disruption of the microbiome associated with long-term antibiotic use. Most clinicians (90%) recognized the importance of antibiotic stewardship.
PROs and Clinician-Reported Outcomes
Significant improvements in AV-related signs domain scores (mean CFB ± SD: –0.8 ± 0.7; P <.0001), impact domain scores (–1.0 ± 1.0; P <.0001), emotional impact subdomain scores (–1.2 ± 1.1; P <.0001), and social impact subdomain scores (–0.6 ± 1.1; P < .0001) measured by ASIS were observed by week 12. For individual ASIS items, most patients reported significant decreases from baseline to week 12 in AV-related signs (items 1-8; P ≤.0006) including oily face, pimples, scars, scabs, dark marks, blackheads, whiteheads, and redness. In addition, 59.3% of patients responded clear/almost clear to the question “How is your acne on your face right now?” at week 12 (P <.0001); and 37.2% responded excellent/very good to the question “Rate how your face looks because of acne” (P <.0001). Most patients reported a significant decrease in AV-related emotional impact at week 12 (ASIS items 11-15; P <.0001). This included feeling sad, embarrassed, self-conscious, annoyed, and being less confident. Most also reported a significant decrease in AV-related social impact at week 12, with fewer patients choosing not to be around other people (P <.0001), and fewer patients receiving criticism about acne (P =.0101; Figure 3).
Clinicians reported a significant increase in the proportion of patients with IGA of 0 or 1 (IGA success) from baseline (0%) to week 12 (58.9%; P <.0001; Figure 4). The proportion of patients with IGA of 3 or 4 significantly declined from 100% at baseline to 11.1% at week 12 (P < .0001). Clinicians were very satisfied or satisfied with treatment outcomes at week 12 for 88.1% of patients.
Safety
The safety population included 184 adults (61.3%) and 116 pediatric patients (38.7%). The mean treatment duration among all patients was 53.2 days with an overall compliance rate of 89.7%. Thirty-eight (12.7%) patients discontinued before week 12 with the most frequent cause being patient voluntary withdrawal or loss to follow-up (n=30; 10.0%; Figure 1). Thirty-one (10.3%) patients reported ≥1 adverse events (AEs) during the study. The majority were mild AEs (n=27; 9.0%). One patient (0.3%) had a serious AE of intracranial hypertension that resolved upon drug withdrawal. Two patients (0.7%) and 4 patients (1.3%) discontinued/withdrew from the study due to AEs not related to oral antibiotic use and related AEs, respectively (Table 2). Among non-related AEs, the most frequently noted groups were skin and subcutaneous tissue disorders (2.0%), nervous system disorders (1.7%), and infections (1.3%). The most frequently reported related AEs were gastrointestinal (2.3%) and nervous system disorders (1.7%). No individual non-related or related-AEs were reported for ≥2% of patients.
DUSCUSSION
AV has a peak prevalence at puberty, impairs multiple aspects of QoL including self-perception, socialization, emotional health, and is often associated with anxiety, depression, and even suicidal intentions.2 More than 40% of patients with AV are anxious regarding their skin condition31 and nearly 70% suffer from depression, more often in females than in males.32 A recent meta-analysis indicated a positive correlation between AV and suicidal ideation33 with 9-12% of suicidal patients indicating acne as the primary cause.31,34,35 Younger patients are more prone to such tendencies than older individuals.34 Better understanding of the psychosocial ramifications of AV and how they might influence treatment selection and outcomes has the potential to improve outcomes and decrease patient burden. Patient-centered research is recognized as valuable in skin conditions as they substantially impact patients’ health-related QoL.36 PROs are useful for evaluating new or existing medications,37 and the validated ASIS questionnaire is considered a high-quality tool for real-world assessment of patient-reported QoL and
