62151 Roflumilast Foam 0.3% in Patients With Scalp and Body Psoriasis: Improvements in Patient-Reported Outcomes

Journal of the American Academy of Dermatology · 2025-09-01

Uveitic Glaucoma Interest Group Recommendations for Uveitis-Related Ocular Hypertension and Glaucoma Management

Ocular Immunology and Inflammation · 2025-09-19 · 1 citations

PURPOSE: Uveitic glaucoma (UG) is a complex disease with nearly three times higher risk for severe visual loss than uveitis without glaucoma. Monitoring and management vary among ophthalmologists, making it difficult to identify optimal follow-up and treatment approaches. The Uveitic Glaucoma Interest Group (UGIG) proposes guidelines to reduce variation in practice through best practice management guidelines for uveitis-related ocular hypertension (UOHT) and UG. METHODS: A group of ophthalmologists with expertise in uveitis and glaucoma conducted an extensive literature review of UOHT and UG. Following review and discussion generated recommendations to standardize best management practices. RESULTS: The recommendations cover: 1) glaucoma-related testing and timing, 2) intraocular pressure (IOP) monitoring and goals, 3) follow-up after starting corticosteroids (CS) or IOP-lowering agents, 4) timing of referral to a glaucoma specialist, 5) management considerations and guidelines. CONCLUSIONS: Uveitic eyes have a heightened risk of developing ocular hypertension (OHT) and glaucoma. IOP is often very high and highly variable, associated with rapid progression rates from OHT to glaucoma, and with more rapid visual field loss. Glaucoma can also develop at lower IOP as compared to non-uveitic patients. The UGIG proposes recommendations to standardize the care of UG patients, facilitating more effective management and optimizing visual outcomes. A consensus is presented regarding IOP management based on a more stringent IOP threshold of 16 mmHg. When possible, a close collaboration between a glaucoma specialist and the uveitis expert is preferred. Appropriate referral to glaucoma specialist should be made early, ideally at the time IOP-lowering therapy is initiated.

Pooled Efficacy, Patient-reported Outcomes, and Safety of Roflumilast Cream 0.15% from the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials of Patients with Atopic Dermatitis and Prior Inadequate Response, Intolerance, and/or Contraindications for Topical Corticosteroids

Journal of Allergy and Clinical Immunology · 2025-02-01

Patient-Reported Outcomes with Roflumilast Foam 0.3% in Patients with Psoriasis of the Scalp and Body in the Phase 3 ARRECTOR Trial

SKIN The Journal of Cutaneous Medicine · 2025-03-17

Introduction: Patients with psoriasis of the scalp or body consider itch the most burdensome symptom. Roflumilast is a highly potent phosphodiesterase 4 inhibitor under investigation as a novel, once-daily foam for treatment of psoriasis of the scalp and body. The impact of roflumilast foam 0.3% on patient-reported outcomes (PROs) in patients with psoriasis of the scalp and body from the phase 3 trial (ARRECTOR; NCT05028582) are reported here. Methods: Patients aged ≥12 years with psoriasis of the scalp and body affecting ≤25% of overall body surface area, minimum Scalp-Investigator Global Assessment (S‑IGA) of Moderate, and minimum Body-IGA (B-IGA) of Mild were randomized 2:1 to once-daily roflumilast foam 0.3% or vehicle for 8 weeks. PROs included the Psoriasis Symptom Diary (PSD; ≥18 years only), Scalpdex, Dermatology Life Quality Index (DLQI; ≥17 years only), Scalp Itch- and Worst Itch-Numeric Rating Scale (SI-NRS and WI‑NRS, respectively; each rated from 0 [no itch] to 10 [worst itch imaginable]). Results: Overall, 281 patients were treated with roflumilast foam 0.3% and 151 were treated with vehicle. In patients with SI-NRS and/or WI-NRS ≥2 at baseline, significantly greater proportions of the roflumilast group than the vehicle group achieved scores of 0 or 1 at Week 8 for SI-NRS (52.3% vs 24.1%; P<0.0001) and/or WI‑NRS (55.4% vs 19.8%; P<0.0001). Similar improvements were observed in other PROs at Week 8, with a significantly greater proportion of the roflumilast group achieving PSD total scores of 0 (19.6% vs 7.1%; P=0.0012). The roflumilast group also had significantly greater reductions in least-squares mean change from baseline in PSD items related to itching/pain/scaling (–10.9 vs –5.8; P<0.0001), Scalpdex score (–23.4 vs –12.8; P<0.0001), and DLQI (–4.4 vs –2.4; P<0.0001). Conclusion: Roflumilast foam 0.3% improved quality of life, including patient reported itching, pain, and scaling, related to psoriasis of the scalp and body. Sponsorship: Arcutis Biotherapeutics, Inc.

62155 Pooled Safety and Local Tolerability of Roflumilast Cream 0.15% From the INTEGUMENT-1 and INTEGUMENT-2 Phase 3 Trials of Patients With Atopic Dermatitis: Subgroup Analysis of Patients With Prior Inadequate Response, Intolerance, and/or Contraindications t

Journal of the American Academy of Dermatology · 2025-09-01

PCR24 Impact of Herpes Zoster Ophthalmicus on Healthcare Utilization and Patient Reported Outcomes: Results from a Multicenter Cohort Study

Value in Health · 2025-07-01

Investigator- and Patient-Rated Local Tolerability in Phase 3 Trials of Topical Roflumilast in Patients With Psoriasis, Seborrheic Dermatitis, and Atopic Dermatitis

SKIN The Journal of Cutaneous Medicine · 2024-01-16

Investigator- and patient-rated local tolerability in phase 3 trials of topical roflumilast in patients with psoriasis, seborrheic dermatitis, and atopic dermatitis Christopher G. Bunick1 on behalf of the authors INTRODUCTION: Formulating a topical medication that does not irritate the skin is an important factor contributing to patient treatment adherence and satisfaction. Many topical prescription products use penetration enhancers (including propylene glycol, polyethylene glycol, and ethanol) to overcome barrier properties of the skin. However, these excipients may irritate the skin causing tolerability reactions such as burning and stinging, which can reduce patient treatment adherence. Topical roflumilast is a highly potent (Kd~0.7 nM) phosphodiesterase 4 inhibitor formulated as a water-based cream or foam that does not contain penetration enhancers or fragrances. We present prospectively assessed investigator- and patient-rated local tolerability from Phase 3 trials of topical roflumilast for patients with psoriasis (DERMIS-1, DERMIS-2, ARRECTOR) seborrheic dermatitis (SD; STRATUM), and atopic dermatitis (AD; INTEGUMENT-1, INTEGUMENT-2). METHODS: Patients were randomized to apply topical roflumilast (DERMIS: 0.3% cream; ARRECTOR and STRATUM: 0.3% foam; INTEGUMENT: 0.15% cream) or vehicle once daily for 8 weeks (DERMIS, ARRECTOR, and STRATUM) or 4 weeks (INTEGUMENT). Investigators assessed local tolerability on an 8-point scale (0 [no evidence of irritation] to 7 [strong reaction spreading beyond application site]) in the clinic before investigational product (IP) application. Patients reported local tolerability on a 4-point scale (0 [none: no sensation] to 3 [severe: hot, tingling/stinging sensation that has caused definite discomfort]) in the clinic 10-15 minutes after IP application. Tolerability was also assessed by reviewing documented adverse events. RESULTS: As assessed by investigators, ≥96.5% of patients in the roflumilast-treated groups had no evidence of irritation at the application site across all trials at all timepoints. Patient-rated local tolerability was favorable and improved with treatment: across all trials, 1% of roflumilast-treated patients reported a score of 3 (severe; defined as a “hot tingling/stinging sensation that has caused definite discomfort”) after the first application (day 1) and <1% at each subsequent assessment. Rates of adverse events, including those at the application site, were low for all trials and <0.5% of roflumilast-treated patients discontinued due to adverse events at the application site across all trials. CONCLUSION: Roflumilast cream and foam formulations demonstrated favorable local tolerability based on investigator- and patient-rated assessments in patients with psoriasis, SD, and AD, including application to sensitive areas such as the face and intertriginous areas. Sponsored by Arcutis Biotherapeutics, Inc. ClinicalTrials.gov Identifiers: DERMIS-1: NCT04211363; DERMIS-2: NCT04211389; ARRECTOR: NCT05028582; STRATUM: NCT04973228; INTEGUMENT-1: NCT04773587; INTEGUMENT-2: NCT04773600

Early adoption of triamcinolone acetonide suprachoroidal injection for uveitic macular edema: a physician survey

BMC Research Notes · 2024-10-23

OBJECTIVE: To obtain physicians' "real-world" perspectives on early experiences with triamcinolone acetonide suprachoroidal injection (SCS-TA) for treatment of patients with uveitic macular edema (UME). RESULTS: Twelve retina/uveitis specialists in the United States were surveyed about SCS-TA injection procedure and patient outcomes. Survey participants administered ≥ 291 SCS-TA injections to 243 patients with UME with various disease characteristics (etiologies, chronicity, and anatomical subtypes). Commonly reported reasons for SCS-TA adoption included potential for lowering the risk of steroid-associated intraocular pressure elevations versus intravitreal injections or implants (100%), potential for longer duration of action versus intravitreal steroid injections or implants (92%), and desire to use a new delivery modality (83%). Nearly all participants (92%) found injection procedure relatively easy post-training, with most (75%) procedurally comfortable after completing 2-5 injections. 58% of participants indicated that their patients gained 2-3 lines of vision by first follow-up visit, and 92% reported having patients who experienced 100-150 μm or greater reduction in central subfield thickness. Overall, 92% of participants were satisfied with SCS-TA treatment outcomes. Findings from this survey of early adopters of SCS-TA indicate that the suprachoroidal injection technique was easy to learn and resulted in favorable patient outcomes consistent with clinical trial data.

Filgotinib in Active Noninfectious Uveitis

JAMA Ophthalmology · 2024-07-18 · 21 citations

Importance: Noninfectious uveitis is a leading cause of visual impairment with an unmet need for additional treatment options. Objective: To assess the efficacy and safety of filgotinib, a Janus kinase 1 (JAK1) preferential inhibitor, for the treatment of noninfectious uveitis. Design, Setting, and Participants: The HUMBOLDT trial was a double-masked, placebo-controlled, phase 2, randomized clinical trial conducted from July 2017 to April 2021 at 26 centers in 7 countries. Eligible participants (aged ≥18 years) had active noninfectious intermediate uveitis, posterior uveitis, or panuveitis despite at least 2 weeks of treatment with oral prednisone (10-60 mg per day). Interventions: Participants were randomly assigned 1:1 to receive filgotinib, 200 mg, or placebo orally once daily for up to 52 weeks. Main Outcomes and Measures: The primary end point was the proportion of participants experiencing treatment failure by week 24. Treatment failure was a composite end point represented by assessment of the presence of chorioretinal and/or retinal vascular lesions, best-corrected visual acuity, and anterior chamber cell and vitreous haze grades. Safety was assessed in participants who received at least 1 dose of study drug or placebo. Results: Between July 26, 2017, and April 22, 2021, 116 participants were screened, and 74 (mean [SD] age, 46 [16] years; 43 female [59.7%] of 72 participants, as 2 participants did not receive treatment doses) were randomly assigned to receive filgotinib (n = 38) or placebo (n = 36). Despite early termination of the trial for business reasons ahead of meeting enrollment targets, a significantly reduced proportion of participants who received filgotinib experienced treatment failure by week 24 vs placebo (12 of 32 participants [37.5%] vs 23 of 34 participants [67.6%]; difference vs placebo -30.1%; 95% CI, -56.2% to -4.1%; P = .006). Business reasons were unrelated to efficacy or safety. Adverse events were reported in 30 of 37 participants (81.1%) who received filgotinib and in 24 of 35 participants (68.6%) who received placebo. Serious adverse events were reported in 5 of 37 participants (13.5%) in the filgotinib group and in 2 of 35 participants (5.7%) in the placebo group. No deaths were reported during the trial. Conclusions and Relevance: Results of this randomized clinical trial show that filgotinib lowered the risk of treatment failure in participants with active noninfectious intermediate uveitis, posterior uveitis, or panuveitis vs placebo. Although the HUMBOLDT trial provided evidence supporting the efficacy of filgotinib in patients with active noninfectious uveitis, the premature termination of the trial prevented collection of additional safety or efficacy information of this JAK1 preferential inhibitor. Trial Registration: ClinicalTrials.gov Identifier: NCT03207815.

How Often Should Children with Juvenile Idiopathic Arthritis Be Seen by the Ophthalmologist?

2024-05-28

Juvenile idiopathic arthritis (JIA) is an autoimmune disease that can affect children of any age. It is also known as juvenile rheumatoid arthritis, juvenile chronic arthritis, or Still’s disease. As the name implies, arthritis is the most frequent presenting symptom and clinical feature in patients afflicted with JIA. The eye is the most common extra-articular site of manifestation. In the eyes, JIA patients most commonly present with anterior uveitis. Identifying signs of ocular involvement can be more challenging in pediatric patients compared with adults because the involved eyes generally do not appear red, children usually don’t complain of symptoms, and they are more difficult to examine.