Data show crisaborole ointment, 2%, a steroid-free topical treatment, was well-tolerated over 4-week treatment period
Safety profile consistent with previous clinical trial experience
NEW YORK, NY, USA I July 01, 2019 I Pfizer Inc. (NYSE:PFE) today announced top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. The data from the trial are supportive of the primary study objective to examine the safety of crisaborole ointment, 2%, in this patient population, and are consistent with previous clinical trial experience.1 Crisaborole ointment, 2%, is currently approved in select countries for mild to moderate AD in patients two years of age and older.2,3,4,5
“This study reinforces our commitment to young AD patients worldwide who need more options,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “These results add to the growing body of evidence that underscores the strength of data for crisaborole as a steroid-free, topical treatment option for people with mild to moderate atopic dermatitis. We look forward to discussing the data with regulatory authorities in the future.”
The primary endpoints of CrisADe CARE 1 were the number of patients with treatment-emergent adverse events (AEs) and severe adverse events (SAEs) and number of patients with clinically significant changes from baseline in height, weight, vital signs, electrocardiogram (ECG), and clinical laboratory parameters.
Detailed analyses of the study will be submitted for presentation at a future scientific meeting.
Crisaborole ointment, 2%, is a novel, steroid-free, topical phosphodiesterase (PDE4) inhibitor.6 It is approved in the U.S. and Canada as EUCRISA® (crisaborole ointment, 2%) and Israel and Australia as STAQUIS™ (crisaborole ointment, 2%) for mild to moderate atopic dermatitis (AD) in patients two years of age and older.2,3,4,5
About the CrisADe CARE 1 Study
The phase 4 crisaborole study (CrisADe CARE 1) was a 4-week, multicenter, open-label, single-arm study to evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment, 2%, applied twice daily (BID) in 125 pediatric patients who were 3 months to less than 24 months of age with mild to moderate atopic dermatitis (AD) involving at least 5% treatable body surface area (%BSA), excluding the scalp. A cohort of 16 of the 125 subjects were included in a subgroup for PK assessment, with clinical diagnoses of moderate AD and a minimum of 35% treatable %BSA, excluding the scalp.1
Additional information about the study can be found at www.clinicaltrials.gov.
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Lesions of AD are characterized by erythema (redness), induration (hardening)/papulation (formulation of papules), and oozing/crusting.7,8
AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.9,10 A total of 45% of all AD cases begin within the first 6 months of life, 60% begin during the first year, and 85% begin before 5 years of age.8,11 Approximately 50% of pediatric AD patients globally have recurrent symptoms into adolescence and adulthood.11,12
About Crisaborole
Crisaborole ointment, 2%, is a novel, steroid-free, topical phosphodiesterase (PDE4) inhibitor.6 It is approved in the U.S. and Canada as EUCRISA® (crisaborole ointment, 2%) and Israel and Australia as STAQUIS™ (crisaborole ointment, 2%) for mild to moderate atopic dermatitis (AD) in patients two years of age and older.2,3,4,5
EUCRISA® (crisaborole) ointment, 2%, IMPORTANT SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
Do not use EUCRISA if you are allergic to crisaborole or any of the ingredients in EUCRISA.
EUCRISA may cause side effects including allergic reactions at or near the application site. These can be serious and may include hives, itching, swelling and redness. If you have any of these symptoms, stop using EUCRISA and get medical help right away.
The most common side effect of EUCRISA is application site pain, such as burning or stinging.
EUCRISA is for use on skin (topical use) only. Do not use EUCRISA in your eyes, mouth or vagina.
INDICATION
EUCRISA is a prescription ointment used on the skin (topical) to treat mild-to-moderate eczema (atopic dermatitis) in adults and children 2 years of age and older.
Please see full prescribing information for EUCRISA in the U.S. here.
Pfizer Inc: Breakthroughs that change patients’ lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
References
1 Data on file. Pfizer Inc. New York, NY.
2 EUCRISA® (crisaborole). Full Prescribing Information. December 2018.
3 EUCRISA™ (crisaborole). Health Canada Product Monograph. June 2018.
4 STAQUIS. Full Prescribing Information Israel. July 2018.
5 STAQUIS™ (crisaborole). Australia Product Information. February 2019.
6 Jarnagin K, Chanda S, Coronado D, et al. Crisaborole topical ointment, 2%: a nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 inhibitor in clinical development for the treatment of atopic dermatitis. J Drugs Dermatol. 2016;15(4):390-396.
7 Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.
8 Bieber T. Atopic dermatitis. Dermatology. 2012;1(3):203-217.
9 Oszukowska M, Michalak I, Gutfreund K, et al. Role of primary and secondary prevention in atopic dermatitis. Postep Derm Alergol. 2015;32(6):409-420.
10 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16.
11 Williams HC. Clinical practice. Atopic dermatitis. N Engl J Med. 2005;352(22):2314-2324.
12 Leung DYM. New Insights into Atopic Dermatitis: Role of Skin Barrier and Immune Dysregulation. Allergol Intl. 2013;62(2):151-161.
SOURCE: Pfizer
Post Views: 59
Data show crisaborole ointment, 2%, a steroid-free topical treatment, was well-tolerated over 4-week treatment period
Safety profile consistent with previous clinical trial experience
NEW YORK, NY, USA I July 01, 2019 I Pfizer Inc. (NYSE:PFE) today announced top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. The data from the trial are supportive of the primary study objective to examine the safety of crisaborole ointment, 2%, in this patient population, and are consistent with previous clinical trial experience.1 Crisaborole ointment, 2%, is currently approved in select countries for mild to moderate AD in patients two years of age and older.2,3,4,5
“This study reinforces our commitment to young AD patients worldwide who need more options,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “These results add to the growing body of evidence that underscores the strength of data for crisaborole as a steroid-free, topical treatment option for people with mild to moderate atopic dermatitis. We look forward to discussing the data with regulatory authorities in the future.”
The primary endpoints of CrisADe CARE 1 were the number of patients with treatment-emergent adverse events (AEs) and severe adverse events (SAEs) and number of patients with clinically significant changes from baseline in height, weight, vital signs, electrocardiogram (ECG), and clinical laboratory parameters.
Detailed analyses of the study will be submitted for presentation at a future scientific meeting.
Crisaborole ointment, 2%, is a novel, steroid-free, topical phosphodiesterase (PDE4) inhibitor.6 It is approved in the U.S. and Canada as EUCRISA® (crisaborole ointment, 2%) and Israel and Australia as STAQUIS™ (crisaborole ointment, 2%) for mild to moderate atopic dermatitis (AD) in patients two years of age and older.2,3,4,5
About the CrisADe CARE 1 Study
The phase 4 crisaborole study (CrisADe CARE 1) was a 4-week, multicenter, open-label, single-arm study to evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment, 2%, applied twice daily (BID) in 125 pediatric patients who were 3 months to less than 24 months of age with mild to moderate atopic dermatitis (AD) involving at least 5% treatable body surface area (%BSA), excluding the scalp. A cohort of 16 of the 125 subjects were included in a subgroup for PK assessment, with clinical diagnoses of moderate AD and a minimum of 35% treatable %BSA, excluding the scalp.1
Additional information about the study can be found at www.clinicaltrials.gov.
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Lesions of AD are characterized by erythema (redness), induration (hardening)/papulation (formulation of papules), and oozing/crusting.7,8
AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.9,10 A total of 45% of all AD cases begin within the first 6 months of life, 60% begin during the first year, and 85% begin before 5 years of age.8,11 Approximately 50% of pediatric AD patients globally have recurrent symptoms into adolescence and adulthood.11,12
About Crisaborole
Crisaborole ointment, 2%, is a novel, steroid-free, topical phosphodiesterase (PDE4) inhibitor.6 It is approved in the U.S. and Canada as EUCRISA® (crisaborole ointment, 2%) and Israel and Australia as STAQUIS™ (crisaborole ointment, 2%) for mild to moderate atopic dermatitis (AD) in patients two years of age and older.2,3,4,5
EUCRISA® (crisaborole) ointment, 2%, IMPORTANT SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
Do not use EUCRISA if you are allergic to crisaborole or any of the ingredients in EUCRISA.
EUCRISA may cause side effects including allergic reactions at or near the application site. These can be serious and may include hives, itching, swelling and redness. If you have any of these symptoms, stop using EUCRISA and get medical help right away.
The most common side effect of EUCRISA is application site pain, such as burning or stinging.
EUCRISA is for use on skin (topical use) only. Do not use EUCRISA in your eyes, mouth or vagina.
INDICATION
EUCRISA is a prescription ointment used on the skin (topical) to treat mild-to-moderate eczema (atopic dermatitis) in adults and children 2 years of age and older.
Please see full prescribing information for EUCRISA in the U.S. here.
Pfizer Inc: Breakthroughs that change patients’ lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
References
1 Data on file. Pfizer Inc. New York, NY.
2 EUCRISA® (crisaborole). Full Prescribing Information. December 2018.
3 EUCRISA™ (crisaborole). Health Canada Product Monograph. June 2018.
4 STAQUIS. Full Prescribing Information Israel. July 2018.
5 STAQUIS™ (crisaborole). Australia Product Information. February 2019.
6 Jarnagin K, Chanda S, Coronado D, et al. Crisaborole topical ointment, 2%: a nonsteroidal, topical, anti-inflammatory phosphodiesterase 4 inhibitor in clinical development for the treatment of atopic dermatitis. J Drugs Dermatol. 2016;15(4):390-396.
7 Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.
8 Bieber T. Atopic dermatitis. Dermatology. 2012;1(3):203-217.
9 Oszukowska M, Michalak I, Gutfreund K, et al. Role of primary and secondary prevention in atopic dermatitis. Postep Derm Alergol. 2015;32(6):409-420.
10 Nutten S. Atopic dermatitis: global epidemiology and risk factors. Ann Nutr Metab. 2015;66(suppl 1):8-16.
11 Williams HC. Clinical practice. Atopic dermatitis. N Engl J Med. 2005;352(22):2314-2324.
12 Leung DYM. New Insights into Atopic Dermatitis: Role of Skin Barrier and Immune Dysregulation. Allergol Intl. 2013;62(2):151-161.
SOURCE: Pfizer
Post Views: 59
