Use of ruxolitinib cream (Opzelura; Incyte) in adults and adolescents with atopic dermatitis (AD) resulted in measurable improvements in skin-related quality of life (QoL) outcomes, such as skin pain , anxiety and depression, according to pooled results from 2 phase 3 studies presented as a poster1 at the Society of Dermatology Physician Assistants (SDPA) 20th Annual Fall Dermatology Conference, November 17-20, 2022 in Miami, Florida.
Using pooled 52-week data from TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), the clinical trials that led to the 2021 FDA approval of the topical JAK1/JAK2 inhibitor, researchers have sought to assess the long-term effects of -need for ruxolitinib cream, as well as the impact of treatment on patient-reported quality of life.
To be included in the studies, patients must be elderly > 12 years old and I have had MA since > 2 years, with a baseline Investigator’s Global Assessment (IGA) score of 2 or 3 and 3% to 20% body surface area affected (BSA), not including the scalp. Patients with unstable AD courses, other types of eczema, who were immunocompromised, or who were using topical AD treatments were not included in the phase 3 studies.
TRuE-AD1 and TRuE-AD2 were designed identically, with patients randomized 2:2:1 to either ruxolitinib cream dosage regimen (0.75% twice daily [BID]1.5% BID) or BID vehicle cream for 8 weeks of continuous double-blind treatment (controlled vehicle [VC] period), according to the investigators. Participants had to continue to treat their lesions even if they noticed an improvement.
Thereafter, patients were enrolled in a double-blind long-term safety period (LTS) of treatment as needed for up to 52 weeks. The group that was initially randomized to receive ruxolitinib continued with their existing regimen, while those who received vehicle cream were randomized 1:1 to either ruxolitinib cream regimen.
During this time, patients were instructed to treat only skin areas with active AD and discontinue treatment 3 days after the lesion disappeared. If lesions recur, patients should resume treatment with ruxolitinib cream. No rescue medication was allowed during the LTS period.
Investigators used the Dermatology Life Quality Index (DLQI) and Children’s DLQI to assess skin-related quality of life in elderly patients > 16 years and for patients aged 12-15 years, respectively, where a lower score equates to less impairment in quality of life.
Outcomes were self-reported when they rated skin pain/discomfort and anxiety/depression over the past week using a 5-point scale (no problems, mild problems , moderate problems, serious problems, extreme problems).
A total of 1249 patients were randomized, with 1072 (85.8%) continuing into the LTS period, and 1031 were ultimately evaluated for efficacy (ruxolitinib cream 0.75%, n=409; cream 1.5% ruxolitinib cream, n=428; 0.75% ruxolitinib cream vehicle, n=98; 1.5% ruxolitinib cream vehicle cream, n=96).
Patients in the 0.75% and 1.5% ruxolitinib arms had a greater mean reduction in DLQI scores from baseline at week 8 compared to patients in the vehicle arms, and these quality of life improvements were were also maintained during the LTS period, with reductions of -7.8 and -7.5 in the ruxolitinib 0.75% and ruxolitinib 1.5% groups, respectively, at week 52. ruxolitinib cream vehicle during the LTS period showed similar improvements at week 12, and those that were maintained through week 52 (–6.9/–7.4 for ruxolitinib 0.75% /1.5%, respectively). Adolescent patients reported similar trends using the CDLQI assessment.
At the end of the LTS period of the study, most patients reported a DLQI score of 0/1, which means that AD has no effect on quality of life.
Reports of skin pain were also reduced in patients using ruxolitinib cream.
“During the LTS period with ruxolitinib cream as needed, the percentage of patients who reported no skin pain/discomfort was maintained for patients who remained in the 0.75% ruxolitinib cream groups /1.5% (week 52, 71.0%/66.9%); similar percentage of patients who switched from vehicle cream to ruxolitinib cream as needed (0.75%/1.5%) during the LTS period reported no skin pain/discomfort (week 52, 70.8%/63.0%),” the investigators reported.
Treatment was well tolerated throughout the LTS period, with 677/1072 (63.2%) people experiencing a therapeutic emergency adverse event (TEAE), most often in the form of a respiratory tract infection upper (10.1%) or nasopharyngitis (9.7%). %).
Overall, treatment with ruxolitinib cream resulted in improvements in measures of quality of life, including skin pain and mental health in both adult and adolescent patient populations. These benefits were also shared by patients who switched to study treatment during the LTS period.
Simpson E, Armstrong A, Chiesa Fuxench C, et al. Effects of ruxolitinib cream on patient-reported quality of life in atopic dermatitis: pooled 52-week results from two phase 3 studies. Poster presented at: SDPA 20th Annual Fall Dermatology Conference; November 17-20, 2022; Miami, Florida. Accessed November 16, 2022. https://www.sdpaconferences.org/hub/events/08d628c0-db6c-4633-8960-74ba986b221a/exhibitors