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Safety profile

Introduction

Staquis® offers a favorable safety profile.3

The safety profile of Staquis® was established in two 29-day pivotal trials, during which application site pain was the only treatment-related adverse event that occurred in >1% of patients.3

 

Adverse events

The most common treatment related adverse event was application site pain—resolved within 1 day of onset in 77.6% of patients3

  • A total of 4.4% (n=45) of Staquis®-treated and 1.2% (n=6) of vehicle-treated patients experienced application site pain, such as stinging and burning3
  • Of the 4.4% who experienced application site pain, 76.7% reported it on the first day of treatment and it resolved within 1 day of onset for 77.6%3

The same rate of discontinuation (1.2%) was observed in patients treated with Staquis® or with vehicle3

 

Long-term safety profile

Following pivotal efficacy trials, Staquis® was assessed in a 48-week long-term safety study.12

 

Study design
The open-label study enrolled 517 adult and paediatric patients who completed one of the Phase 3 registration studies (AD-301 or AD-302) and assessed each patient’s ISGA score at baseline and every 28 days.12

The primary endpoints were adverse events, serious adverse events and rescue therapy use, defined as the need for concomitant, non-concurrent use of low- to mid-potency TCS or TCI.

Safety parameters included adverse events, clinical laboratory tests, local tolerability and vital signs.12

Patients used Staquis® twice daily for 28 days for up to 12 cycles according ISGA evaluation every 28 days that was done by the investigator.12†

There were no reports of application site atrophy or telangiectasia with Staquis® treatment.12

The discontinuation rate due to adverse events was 1.7% for Staquis®.12

 

Open-label extension—treatment-related adverse events occurring in >1% of patients12

  • 2% (n=12) application site pain
  • 1% (n=6) application site infection
  • 3% (n=16) dermatitis atopic (worsening, exacerbation, flare or flare-up)

77.8% of Staquis®-treated patients did not require rescue therapy with TCI or TCS12

†The mean number of cycles on treatment was 6.2 across all patient age groups.

Treatment was discontinued if no improvement in ISGA score was observed after 3 consecutive on-treatment periods.12

 

†For topical use only, not for ophthalmic, oral or intravaginal use.

‡ISGA Grade 4 patients were excluded from Staquis® clinical trials.3

¥Trial 1 (AD-301) and Trial 2 (AD-302).3

 

A Phase IV Open Label Study (CrisADe CARE 1)
Safety, Effectiveness, and Pharmacokinetics of Crisaborole in Infants Aged 3 to 24 months with Mild to Moderate Atopic Dermatitis
Crisaborole was well tolerated and effective in infants (3 to 24 months) with mild to moderate AD with systemic exposure similar to patients 2 years and older.
no new safety signals were identified.

 

References

  1. Staquis® (crisaborole) latest approved prescribing information.
  2. Guttman-Yassky E, Hanifin J et al. Exp Dermatol 2019;28(1):3–10.
  3. Paller A, Tom W et al. J Am Acad Dermatol 2016;75(3):494–503.e6.
  4. Jarnagin K, Chanda S et al. J Drugs Dermatol 2016;15(4):390–396.
  5. Hanifin J, Chan S et al. J Invest Dermatol 1996;107(1):51–56.
  6. Simpson E, Paller A et al. Poster presented at Maui Derm NP+PA Fall Meeting; 2009; 28 September–1 October; Asheville, NC. Poster O063.
  7. Data on file. Pfizer Inc., New York, NY. Outcomes Report Dossier 2017.
  8. Yosipovich G, Simpson E et al. Itch (2019) 4:e21
  9. Data on file. Pfizer Inc., New York, NY. Clinical Study Report. 2015.
  10. Data on file. Pfizer Inc., New York, NY. Summary of Clinical Efficacy. 2016.
  11. Yarbrough K, Neuhaus K et al. Dermatol Ther 2013;26(2):110–119.
  12. Eichenfield L, Call R et al. J Am Acad Dermatol 2017;77(4):641–649.e5.
  13. Boguniewicz M, Fonacier L et al. Ann Allergy Asthma Immunol 2018;120(1):10–22.
  14. Yosipovich G, Stein Gold L et al. Acta Derm Venereol 2018; 98: 484–489