AB190 Abstracts
FEBRUARY 2020
608 Efficacy Trends With Continuous Long-Term Use
of Crisaborole in Patients With Mild-to-
Moderate Atopic Dermatitis (AD)
Mark Lebwohl1, Adelaide Hebert2, Liza Takiya3, Lauren Miller4, John
Werth3, Chuanbo Zang3, Paul Sanders5, Bob Geng, MD6; 1Icahn School
of Medicine at Mount Sinai, 2UTHealth McGovern School of Medicine,
3
Pfizer Inc., 4Dermatology Specialists, 5Pfizer R&D UK Ltd., 6UC San
Diego School of Medicine.
RATIONALE: AD is chronic inflammatory skin disease that often
requires long-term treatment. Crisaborole significantly improved global
signs and symptoms of AD in phase 3 studies. This post hoc analysis
assessed the efficacy of continuous, long-term crisaborole in patients with
mild-to-moderate AD in a 48-week, open-label extension study.
METHODS: Patients > _2 years who completed a phase 3 study without
treatment-related safety issues were eligible. All patients received
crisaborole initially. Patients with Investigator’s Static Global
Assessment (ISGA) 0 (clear)/1 (almost clear) at the end of a 28-day cycle
did not receive crisaborole for the next 28-day cycle (off-treatment);
patients with ISGA >_2 (mild) received crisaborole for the next 28-day cycle
(on-treatment). Patients were stratified by number of initial consecutive 28-
day cycles of crisaborole received during the extension study.
RESULTS: Overall, 418 patients were included in exclusive cohorts (1 on-
treatment cycle, n5133; 2 consecutive on-treatment cycles, n5106; 3
consecutive on-treatment cycles, n5106; and 4 consecutive on-treatment
cycles, n573). In all groups, <3% of patients discontinued treatment
during initial consecutive on-treatment cycles. After 1-4 consecutive on-
treatment cycles, 77.6%, 76.3%, 59.4%, and 43.1% of patients achieved
ISGA 0/1, respectively. Of these, 51.0%, 36.7%, 35.6%, and 36.2%
maintained ISGA 0/1 at the end of the next 28-day cycle while off
treatment. Of patients with 1-4 initial consecutive on-treatment cycles,
60.2%, 64.2%, 74.5%, and 82.2% reinitiated crisaborole after a mean of 1.8
(range, 0-11) off-treatment cycles.
CONCLUSIONS: Continuous long-term treatment with crisaborole
beyond 28 days may be necessary to maintain control of AD symptoms
in some patients with mild-to-moderate AD.
609 Dupilumab Treatment Results in Rapid
Improvement in Itch in Adult and Adolescent
Patients With Moderate-to-Severe Atopic
Dermatitis (LIBERTY AD SOLO 1 & 2, and ADOL
trials)
Gil Yosipovitch, MD1, Chih-ho Hong2, Eric Simpson, MD MCR3, Lau-
rent Eckert4, Zhen Chen5, Paola Mina-Osorio, MD, PhD6, Abhijit Gad-
kari, PhD5; 1University of Miami, Miami, FL, USA, 2University of
British Columbia, Surrey, BC, Canada & Probity Medical Research, Wa-
terloo, ON, Canada, 3Oregon Health & Science University, Portland, OR,
USA, 4Sanofi, Chilly-Mazarin, France, 5Regeneron Pharmaceuticals, Inc.,
Tarrytown, NY, USA, 6Regeneron Pharmaceuticals.
RATIONALE: Atopic dermatitis (AD) is characterized by intense pru-
ritus/itch that negatively impacts patient’s quality of life; therefore,
improvement in pruritus is an important marker of treatment benefit.
Dupilumab is approved in the USA for adults and adolescents with
inadequately-controlled moderate-to-severe AD. Here we assessed
MONDAY
improvement in pruritus in dupilumab- vs placebo-treated adult and
adolescent AD patients.
METHODS: SOLO 1/2 ([adults]: NCT02277743/NCT02277769) pa-
tients received 300mg dupilumab weekly (qw) or every 2 weeks (q2w), or
placebo. ADOL ([adolescents]: NCT03054428) patients received 200/
300mg dupilumab q2w, 300mg every 4 weeks (q4w), or placebo. This
post-hoc analysis evaluated daily change from baseline to Day15 in Peak
Pruritus Numerical Rating Scale (NRS) score.
RESULTS: Baseline characteristics were comparable among treatment
groups within trials, though with higher disease severity in adolescents.
Baseline Peak Pruritus NRS scores (standard deviation) in adults were 7.3
J ALLERGY CLIN IMMUNOL
(1.9)/7.4 (1.8)/7.4 (1.8) for qw/q2w/placebo groups, respectively, and in
adolescents 7.5 (1.5)/7.5 (1.8)/7.7 (1.6) for q2w/q4w/placebo groups,
respectively. Dupilumab treatment vs placebo resulted in significant
improvement in pruritus as early as Day2 in adults (P< _0.003) and Day6
in adolescents (P<0.01) as measured by least squares (LS) mean percent
change in Peak Pruritus NRS score. At Day15 in adults, LS mean percent
change (standard error) was 222.5 (1.4)/224.7 (1.4)/23.4 (1.4) for qw/
q2w/placebo groups, respectively (P<0.0001 for both doses).
Corresponding values in adolescents were 225.3 (2.7)/221.8 (2.7)/25.7
(2.6) for q2w/q4w/placebo groups, respectively (P<0.0001 for both doses).
Dupilumab was generally well-tolerated with an acceptable safety profile.
CONCLUSIONS: Dupilumab treatment demonstrated rapid improve-
ment in pruritus/itch in adult and adolescent patients with moderate-to-
severe AD.
610 Efficacy of Baricitinib in Patients with Atopic
Dermatitis and Atopic Comorbidities: Results of
Pooled Data from 2 Phase 3 Monotherapy
Randomized, Double-Blind, Placebo-Controlled
16-week Trials (BREEZE-AD1 and BREEZE-AD2)
Andreas Wollenberg1, Mark Boguniewicz, MD FAAAAI2, Jeffrey Tra-
vers3, Jacob Thyssen, MD4, Orin Goldblum, MD5, Susan Ball5, Luna
Sun5, Sherry Chen6, Jonathan Silverberg, MD, PHD, MPH7; 1Ludwig-
Maximillian University, 2National Jewish Health, 3Wright State Univer-
sity, 4University of Copenhagen, 5Eli Lilly and Company, 6Syneos Health,
7
Northwestern University Feinberg School.
RATIONALE: Asthma and allergic rhinitis are frequent atopic comor-
bidities in atopic dermatitis (AD). In 2 independent phase 3 trials of
baricitinib for moderate-to-severe AD, 71% (n5878) of patients had > _1
atopic comorbidity. We report treatment efficacy and safety in this
population.
METHODS: BREEZE-AD1(NCT03334396, N5624) and BREEZE-
AD2 (NCT03334422, N5615) were double-blind trials (randomization
[2:1:1:1]: placebo or baricitinib 1-mg, 2-mg, or 4-mg once-daily for 16
weeks). Using pooled data, patients with atopic comorbidities were
compared by treatment on efficacy outcomes (Investigator’s Global
Assessment [IGA]; Eczema Area and Severity Index [EASI]; Itch numeric
rating scale [NRS]) at week 16 and on safety outcomes.
RESULTS: At baseline, most common atopic comorbidities were allergic
rhinitis (57.7%), seasonal allergy (45.9%), asthma (41.2%) and food
allergy (40.7%). At week 16, among patients with atopic comorbidities,
significantly more patients in the baricitinib-treated groups (4-mg, 2-mg,
and 1-mg, respectively) vs. placebo had IGA rated mild or less (IGA< _2)
(29.8%, 25.0%, and 18.6% vs. 9.8%) or EASI 50 (32.7%, 29.0%, and
20.3%, vs. 11.5%), p< _0.01 for all comparisons. Patients with atopic
comorbidities experienced improvement in itch (> _4 points) with baricitinib
4-mg (21.6%), 2-mg (16.6%), and 1-mg (10.1%) vs placebo (4.4%; p< _0.05
for all). There were no significant treatment effect differences in patients
with or without atopic comorbidities. Overall safety outcomes for patients
with atopic comorbidities were similar to outcomes in the overall
population.
CONCLUSIONS: In patients with moderate-to-severe AD with an
additional comorbid atopic condition, baricitinib treatment resulted in
clinically meaningful improvements in skin symptoms and itch without a
differential safety profile.