April 2025
JAAD Case Reports
This page lists works of an author who doesn't have a ResearchGate profile or hasn't added the works to their profile yet. It is automatically generated from public (personal) data to further our legitimate goal of comprehensive and accurate scientific recordkeeping. If you are this author and want this page removed, please let us know.
April 2025
JAAD Case Reports
March 2025
·
1 Read
Dermatitis
March 2025
·
9 Reads
SKIN The Journal of Cutaneous Medicine
Introduction: In ADORING 1 and 2 phase 3 trials, tapinarof cream 1% (VTAMA®, Dermavant Sciences, an Organon Company) once daily (QD) demonstrated superior efficacy and was well tolerated in patients down to age 2 years with atopic dermatitis (AD). We present efficacy, safety, and tolerability from ADORING 3. Methods: Patients from ADORING 1 and 2, from a 4-week maximal usage pharmacokinetics trial, and tapinarof-naive patients with mild AD, or moderate or severe AD, that did not meet ADORING 1 or 2 inclusion criteria, received tapinarof cream 1% QD for up to 48 weeks. Endpoints included achievement of complete disease clearance (Validated Investigator Global Assessment for Atopic Dermatitis™ [vIGA-AD™]=0 [clear]), and clear or almost clear skin (vIGA-AD™=0 or 1). Patients entering with vIGA-AD™≥1 received tapinarof until vIGA-AD™=0. Those entering with or achieving vIGA-AD™=0 discontinued tapinarof and were assessed for maintenance of vIGA-AD™=0 or 1 (treatment-free interval). Patients with vIGA-AD™≥2 were re-treated until vIGA-AD™=0. Results: 728 patients enrolled; 83.0% pediatric (2–17 years). Overall, 51.9% entered with or achieved vIGA-AD™=0, and 81.6% entered with or achieved vIGA-AD™=0 or 1 at least once during ADORING 3. Mean duration of first treatment-free interval was 79.8 consecutive days (standard deviation: 81.4 days). No tachyphylaxis on either continuous or intermittent therapy was observed for up to 48 weeks. Most frequent treatment-emergent adverse events (TEAEs) were folliculitis (12.1%), nasopharyngitis (6.9%), and upper respiratory tract infection (6.9%). Trial discontinuations due to TEAEs were low (2.6%). Follicular events and contact dermatitis were mostly mild or moderate and associated with low discontinuations (1.0% and 0.4%, respectively). Tapinarof was well tolerated, even on sensitive skin. Conclusions: Tapinarof cream monotherapy was well tolerated and demonstrated high rates of complete disease clearance (51.9%) in patients down to age 2 years with AD. After discontinuing tapinarof, clear or almost clear skin was maintained for 79.8 consecutive days. No new safety signals and low rates of trial discontinuation were observed.
March 2025
·
3 Reads
Journal of Investigative Dermatology
March 2025
Journal of Investigative Dermatology
March 2025
·
1 Read
Journal of Investigative Dermatology
March 2025
Journal of Clinical and Aesthetic Dermatology
March 2025
·
3 Reads
The Journal of Allergy and Clinical Immunology In Practice
March 2025
·
4 Reads
Journal of Investigative Dermatology
February 2025
·
43 Reads
Atopic dermatitis (AD) is a chronic inflammatory disease affecting ~ 10% of adults and ~ 20% of children globally. Many patients with moderate-to-severe AD receiving systemic therapies, including biologics and Janus kinase (JAK) inhibitors, fail to reach or maintain treatment goals due to lack of durable response or safety/tolerability issues. Rocatinlimab is a T-cell rebalancing therapy that inhibits and reduces pathogenic T cells by targeting the OX40 receptor. ROCKET, a large, global phase 3 program of eight clinical trials (NCT05398445; NCT05651711; NCT05724199; NCT05899816; NCT05704738; NCT05633355; NCT05882877; NCT06224192), will evaluate the efficacy, durability of response, and long-term safety of rocatinlimab as monotherapy and combination therapy in adult and adolescent patients with moderate-to-severe AD with or without prior exposure to biologics or systemic JAK inhibitors.
... Furthermore, Phase 2b data on orismilast in psoriasis (IASOS) indicated a deeper response for this indication compared to apremilast based on the proportion of patients achieving PASI90 (orismilast 20 mg: 24.1%; 30 mg: 22.0%; 40 mg: 28.3%; placebo: 8.3%; p < 0.05 for 20 and 40 mg doses), which is numerically greater than for apremilast (30 mg: 9.8% vs placebo: 0.4%, p < 0·05) [7]. Recently, we reported clinical data on orismilast from a 16-week Phase 2b study in patients with AD, and although not all endpoints reached statistical significance, more patients achieved an Investigator's Global Assessment (IGA) of 0/1 at Week 16 in the orismilast groups compared to placebo (orismilast 20 mg: 26.3%; 30 mg: 24.3%; 40 mg: 30.9%; placebo: 9.5%; p < 0.05 for 20 and 40 mg doses) [8]. These data suggest that the clinical relevance of selective PDE4B/D inhibition with orismilast has potential to offer a convenient, novel oral therapy to treat psoriasis and AD. ...
January 2025
British Journal of Dermatology
... Once-daily roflumilast cream 0.05% significantly improved AD signs and symptoms in pediatric patients aged 2-5 years, with significant improvement in vIGA-AD observed as early as the first timepoint (1 week after treatment initiation) and improvement in pruritus within the first 24 h. [19]. Therefore, a longer duration of treatment in patients aged 2-5 years may lead to a greater EASI-75 response, similar to that observed in patients aged ≥ 6 years who participated in the INTEGUMENT-OLE trial. ...
January 2025
Dermatitis
... In recent years, biologics and JAK inhibitors have emerged as key systemic therapies to control flares and potentially reach a Minimal Disease Activity (MDA) status in individuals with moderate-tosevere AD [1]. For patients who achieve optimal outcomes with biological therapy, reducing the dosing frequency (optimization) may be a viable consideration [2,3]. This approach holds particular significance for elderly individuals (> 65 years), who are often on multiple medications and have several comorbidities [2,3]. ...
December 2024
British Journal of Dermatology
... While these 8-week trials were of relatively short duration, the subsequent long-term extension trial, ADORING 3, assessed the efficacy, safety, and tolerability of tapinarof cream in AD across the spectrum of severity, including patients with mild or more severe AD for up to 48 weeks (25). Tapinarof was effective for a diverse patient population across these trials, with an age range of 2 to 81 years (80% pediatric patients in ADORING 1 and 2) and approximately 50% with skin of color (21,25). ...
November 2024
SKIN The Journal of Cutaneous Medicine
... Improvements were obtained in a number of indicators including pruritus, sleep, skin pain and overall quality of life, which was maintained for 44 weeks of its use as needed. 16 Topical tofacitinib has undergone a 4-week randomized double-blind phase 2a study. The 2% ointment achieved satisfactory results in the treatment of AD, but side effects such as nasopharyngitis, upper respiratory tract infection are the reason for the lack of research development for this drug. ...
November 2024
American Journal of Clinical Dermatology
... 3 In GERD patients, biopsies of the distal, squamous-lined esophagus typically reveal thickening of the basal cell layer, papillary elongation, and dilated intercellular spaces. 4 However, neither the symptoms nor histologic features of GERD are specific to the disorder, and an objective diagnosis of GERD requires endoscopic evidence of Los Angeles grade B, C, or D reflux esophagitis, and/ or Barrett's esophagus with intestinal metaplasia, and/or esophageal reflux monitoring demonstrating abnormal reflux. 5 Eosinophilic esophagitis (EoE) is an allergy-mediated esophageal disease characterized clinically by symptoms of esophageal dysfunction (typically dysphagia and food impaction) and histologically by eosinophil-predominant esophageal inflammation. ...
November 2024
Dermatology and Therapy
... In clinical trials, standardized quality-of-life questionnaires and clinical disease assessment tools showed improvements for both diseases in ages 6 to < 18 years [20][21][22][23]. Dupilumab has been associated with an improvement in symptoms and quality of life [24][25][26]. However, only a limited number of pediatric patients have been assessed in real-world observational studies outside the controlled environment of phase 3 trials [27][28][29][30][31][32]. ...
September 2024
Journal of the American Academy of Dermatology
... Recent advances in biologic therapies for AD are notable, particularly pharmacological inhibition of IL-4 and 13 signaling with dupilumab have shown outstanding clinical efficacy for patients with AD [21,22]. In addition, dupilumab has shown concomitant improvements in critical factors of moderate-to-severe AD pathogenesis, including decreased abundance of S. aureus on the skin surface [21,22]. ...
September 2024
Journal of Allergy and Clinical Immunology
... Prolonged use of topical corticosteroids on the face is not recommended and is associated with skin atrophy, periorificial dermatitis, rebound dermatitis, acneiform changes, and rosacea (1,7,8,(11)(12)(13). Application site burning in the face is common with topical calcineurin inhibitors and phosphodiesterase-4 inhibitors (7,14,15), albeit less frequently with roflumilast (16). Thus, there is a need for additional effective and tolerable topical therapies for the treatment of facial and neck AD. ...
September 2024
... Our results confirm the data on safety observed in both clinical trials and real-life studies regarding the risk of VTEs during therapy with JAK inhibitors for moderate-to-severe AD: a recent systematic review and meta-analysis reported no significant differences between patients with AD receiving dupilumab or placebo and those on JAK inhibitor therapy, with the latter showing an overall incidence of 0.15 events per 100 patient-years [19]. Recent evidence on the safety profile related to the development of malignancies and MACE in patients with AD receiving JAK inhibitor therapy indicates a low incidence, suggesting a lower risk compared with patients with RA [20]. However, the possibility of longterm risk cannot be excluded. ...
September 2024
British Journal of Dermatology