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No new safety signals were identified, and adverse events were consistent 
with the known apremilast safety profile

Primary outcome: Psoriasis severity assessed by the proportion of patients 
achieving an sPGA response at week 16 (sPGA response: a score of 0/1 
[clear/almost clear skin] with a ≥ 2-point reduction from baseline)

Presented at: Winter Clinical Dermatology Conference - Hawaii 2023; January 13–18, 2023; HI, USA © 2023 Amgen Inc.

Disclosures and Funding Statement
LF: Amgen, Galderma, LEO Pharma, and Pfizer – investigator, received honoraria, and advisory board member; Pierre Fabre and Galderma – speaker. EB: Amgen – principal investigator; Pfizer, Regeneron, and Sanofi – speaker. RdL: nothing to disclose. AB-F: AbbVie, Janssen, Novartis, Pfizer, and Sanofi – consultant and received fees and honoraria. SA: Amgen, Janssen, LEO Pharma, and Novartis – speaker and advisory board member. PM, RKO, MP, WZ, and ZZ: Amgen – employees and stockholders. 
LA: Candela – received research equipment; Amgen and Celgene – investigator; AbbVie, Amgen, Regeneron, and Verrica – consultant. This study was sponsored by Amgen Inc. Writing support was funded by Amgen Inc. and provided by Lakshmi Narendra Bodduluru, PhD, of Cactus Life Sciences (part of Cactus Communications), and Dawn Nicewarner, PhD, CMPP, employee of and stockholder in Amgen Inc.

PASI-75 response: a ≥ 75% reduction in PASI scores from baseline.
PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

Approved oral or injectable therapies for children with moderate 
to severe psoriasis are limited

Apremilast, an oral immunomodulator that inhibits PDE4, is 
approved for use in adults with psoriasis, psoriatic arthritis, and 
oral ulcers associated with Behçet’s disease

Apremilast has shown favorable effects over risks in 706,585
adults globally, across the indications for which it is approved

To evaluate how well apremilast works and how safe it is in children with 
moderate to severe psoriasis that was inadequately controlled by or intolerant to 
medications applied to the skin

Key secondary outcome: Psoriasis improvement assessed by the proportion of 
patients achieving a PASI-75 response at week 16 to assess psoriasis severity

PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

Efficacy and Safety Results of Apremilast in Pediatric Patients With Moderate to Severe Plaque Psoriasis:
16-Week Results From SPROUT, a Phase 3, Randomized, Controlled Study

Loretta Fiorillo, MD1; Emily Becker, MD2; Raul de Lucas, MD3; Anna Belloni-Fortina, MD4; Susana Armesto, MD5; Peter Maes, BA6; Rajneet K. Oberoi, BPharm, PhD6; 
Maria Paris, MD6; Wendy Zhang, MD, MSc6; Zuoshun Zhang, PhD6; Lisa Arkin, MD7

Key takeaways Apremilast was well tolerated and effectively reduced psoriasis severity in children aged 6 to 17 years with moderate to severe plaque psoriasis that was inadequately controlled by or intolerant to medications applied to the skin

For additional findings, 
scan the QR code

1Stollery Children’s Hospital, University of Alberta, Edmonton, Alberta, Canada; 2Driscoll Children’s Hospital, Corpus Christi, TX, USA; 3Hospital Universitario La Paz – PPDS, Madrid, Spain; 4Azienda Ospedale Università Padova, 
Padova, Italy; 5Hospital Universitario Marques de Valdecilla, Santander, Spain; 6Amgen Inc., Thousand Oaks, CA, USA; 7University of Wisconsin School of Medicine and Public Health, Madison, WI, USA

AMP, adenosine monophosphate; cAMP, cyclic adenosine monophosphate; IL, interleukin; PDE, phosphodiesterase; 
TNF-α, tumor necrosis factor alpha.

The percentage of patients in the age and weight categories was similar between 
apremilast and placebo groups

3x

Achievement of 
clear/almost clear skin

(sPGA response)

vs

33.1%

11.5%

Apremilast Placebo

~3x
vs

Improvement in disease 
severity by ≥ 75%

(PASI-75 response)

45.4%

16.1%

Apremilast Placebo

This phase 3 study included 
245 participants from 

99 centers in 10 countries 
(NCT03701763)

What was our aim?

IL-17A 
IL-17F
IL-22 
TNF-α

IL-10

5′-AMP

Apremilast

−

P
D

E
4

cAMP

What do we know? What did we do? What were our findings at week 16?

Week 16

163 patients

Week 0 Week 52 Week 66
2:

1

82 patients Placebo

Apremilast

Fo
llo

w
-u

p

Apremilast

Apremilast

245 patients 
randomized

(age: 6–17 years)
Pro-inflammatory mediators

Anti-inflammatory mediators


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