– HUMIRA is now the first-and-only biologic treatment with fingernail psoriasis data in its U.S. prescribing information for moderate to severe chronic plaque psoriasis patients
– Phase 3 data demonstrate improvement in moderate to severe fingernail psoriasis
NORTH CHICAGO, IL, USA I March 30, 2017 I AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. HUMIRA is now the first-and-only biologic treatment with data on fingernail psoriasis in its U.S. prescribing information.
Fingernail psoriasis affects half of all psoriasis patients.1,2 It is a form of chronic plaque psoriasis characterized by pitting, deformation, thickening, discoloration, pain and separation of the nail from the nail bed.1,3 Nail psoriasis can also contribute to social stigmatization and impact quality of life. 2
“Fingernail psoriasis is often difficult to treat, and we are pleased the FDA recognized the importance of these data so that more healthcare providers can make informed medical decisions when prescribing treatments for those living with psoriasis,” said John Medich, Ph.D., vice president, clinical development, Immunology, AbbVie. “AbbVie’s nearly 20 years of research in immunology provides us with in-depth knowledge of challenging diseases and allows us to identify ways to address them – it is our hope that the fingernail psoriasis data will support healthcare providers treating this difficult condition.”
The Phase 3 study was dedicated to evaluating fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis. The study demonstrated nearly half of adult patients treated with HUMIRA achieved an assessment of clear or minimal with at least a two-grade improvement from baseline in signs and symptoms of fingernail psoriasis compared to 6.9 percent of placebo patients (p<0.001). No new safety signals for HUMIRA were observed in the study.
In 2008, HUMIRA was FDA approved to treat adults with moderate to severe chronic plaque psoriasis who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate. These fingernail psoriasis data are included as a third psoriasis study (Study Ps-III) in the plaque psoriasis clinical studies section (14.8) of the HUMIRA label and can be found here.
About the Phase 3 Fingernail Psoriasis Study4
This Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study (NCT02016482) evaluated the safety and efficacy of HUMIRA in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis. During the first 26-weeks, enrolled patients (n=217) were randomized to receive HUMIRA 40mg every other week (n=109) starting one week after an initial 80mg dose or matching placebo (n=108). The primary endpoint was met, with 48.9 percent of HUMIRA-treated patients achieving a Physician’s Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal) with at least a two-grade improvement from baseline at week 26 versus 6.9 percent for placebo patients (p<0.001).
Through 26 weeks, there were no new safety signals with HUMIRA 40mg every other week. Adverse events (AEs) were reported by 56.9 percent of HUMIRA-treated patients and 55.6 percent of placebo-treated patients. Serious AEs were reported by 7.3 percent and 4.6 percent, respectively, including serious infections in 3.7 percent of those treated with HUMIRA compared to 1.9 percent receiving placebo. The difference between these two groups was not statistically significant.
About HUMIRA in the U.S.
Uses7
HUMIRA is a prescription medicine used:
- To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
- Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
- Moderate to severe hidradenitis suppurativa (HS) in adults.
- In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
- To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
- To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs approximately 29,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
References
- Pasch MC. Nail psoriasis. Drugs. 2016;76(6):675-705.
- R.G. Langley, J.H. Saurat, K. Reich, et al. Recommendations for the treatment of nail psoriasis in patients with moderate to severe psoriasis: a dermatology expert group consensus. J Eur Acad Dermatol Venereol. 2011;26:373-381.
- Treating specific locations: Hands, Feet and Nails. National Psoriasis Foundation website. Available at: https://www.psoriasis.org/about-psoriasis/specific-locations/hands-feet-nails. Accessed February 3, 2017.
- Elewski BE, Rich PA, Okun MM, et al. Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial. Abstract P131. 5th Congress of the Psoriasis International Network (Psoriasis 2016) Paris, France. 2016:1-8.
- About Psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriasis. Accessed February 3, 2017.
- Rigopoulos D. (2014). Nail Psoriasis From A to Z. DOI: 10.1007/978-3-319-08810-5. Accessed May 20, 2016. Available at: http://link.springer.com/book/10.1007/978-3-319-08810-5.
- Humira Injection [Package Insert]. North Chicago, IL: AbbVie Inc.
- HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://ec.europa.eu/health/documents/community-register/2016/20160624135201/anx_135201_en.pdf. Last updated November 28, 2016. Accessed February 16, 2017.
SOURCE: AbbVie
Post Views: 54
– HUMIRA is now the first-and-only biologic treatment with fingernail psoriasis data in its U.S. prescribing information for moderate to severe chronic plaque psoriasis patients
– Phase 3 data demonstrate improvement in moderate to severe fingernail psoriasis
NORTH CHICAGO, IL, USA I March 30, 2017 I AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. HUMIRA is now the first-and-only biologic treatment with data on fingernail psoriasis in its U.S. prescribing information.
Fingernail psoriasis affects half of all psoriasis patients.1,2 It is a form of chronic plaque psoriasis characterized by pitting, deformation, thickening, discoloration, pain and separation of the nail from the nail bed.1,3 Nail psoriasis can also contribute to social stigmatization and impact quality of life. 2
“Fingernail psoriasis is often difficult to treat, and we are pleased the FDA recognized the importance of these data so that more healthcare providers can make informed medical decisions when prescribing treatments for those living with psoriasis,” said John Medich, Ph.D., vice president, clinical development, Immunology, AbbVie. “AbbVie’s nearly 20 years of research in immunology provides us with in-depth knowledge of challenging diseases and allows us to identify ways to address them – it is our hope that the fingernail psoriasis data will support healthcare providers treating this difficult condition.”
The Phase 3 study was dedicated to evaluating fingernail psoriasis in patients with moderate to severe chronic plaque psoriasis. The study demonstrated nearly half of adult patients treated with HUMIRA achieved an assessment of clear or minimal with at least a two-grade improvement from baseline in signs and symptoms of fingernail psoriasis compared to 6.9 percent of placebo patients (p<0.001). No new safety signals for HUMIRA were observed in the study.
In 2008, HUMIRA was FDA approved to treat adults with moderate to severe chronic plaque psoriasis who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate. These fingernail psoriasis data are included as a third psoriasis study (Study Ps-III) in the plaque psoriasis clinical studies section (14.8) of the HUMIRA label and can be found here.
About the Phase 3 Fingernail Psoriasis Study4
This Phase 3, multicenter, double-blind, randomized, parallel-arm, placebo-controlled study (NCT02016482) evaluated the safety and efficacy of HUMIRA in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis. During the first 26-weeks, enrolled patients (n=217) were randomized to receive HUMIRA 40mg every other week (n=109) starting one week after an initial 80mg dose or matching placebo (n=108). The primary endpoint was met, with 48.9 percent of HUMIRA-treated patients achieving a Physician’s Global Assessment-fingernail-psoriasis of 0 (clear) or 1 (minimal) with at least a two-grade improvement from baseline at week 26 versus 6.9 percent for placebo patients (p<0.001).
Through 26 weeks, there were no new safety signals with HUMIRA 40mg every other week. Adverse events (AEs) were reported by 56.9 percent of HUMIRA-treated patients and 55.6 percent of placebo-treated patients. Serious AEs were reported by 7.3 percent and 4.6 percent, respectively, including serious infections in 3.7 percent of those treated with HUMIRA compared to 1.9 percent receiving placebo. The difference between these two groups was not statistically significant.
About HUMIRA in the U.S.
Uses7
HUMIRA is a prescription medicine used:
- To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
- Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to bones and joints and may help the ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to certain other medications. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
- Moderate to severe Crohn’s disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
- Moderate to severe hidradenitis suppurativa (HS) in adults.
- In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
- To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.
- To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.
About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs approximately 29,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
References
- Pasch MC. Nail psoriasis. Drugs. 2016;76(6):675-705.
- R.G. Langley, J.H. Saurat, K. Reich, et al. Recommendations for the treatment of nail psoriasis in patients with moderate to severe psoriasis: a dermatology expert group consensus. J Eur Acad Dermatol Venereol. 2011;26:373-381.
- Treating specific locations: Hands, Feet and Nails. National Psoriasis Foundation website. Available at: https://www.psoriasis.org/about-psoriasis/specific-locations/hands-feet-nails. Accessed February 3, 2017.
- Elewski BE, Rich PA, Okun MM, et al. Adalimumab for nail psoriasis: Efficacy and safety from the first 26 weeks of a phase 3, randomized, placebo-controlled trial. Abstract P131. 5th Congress of the Psoriasis International Network (Psoriasis 2016) Paris, France. 2016:1-8.
- About Psoriasis. National Psoriasis Foundation website. https://www.psoriasis.org/about-psoriasis. Accessed February 3, 2017.
- Rigopoulos D. (2014). Nail Psoriasis From A to Z. DOI: 10.1007/978-3-319-08810-5. Accessed May 20, 2016. Available at: http://link.springer.com/book/10.1007/978-3-319-08810-5.
- Humira Injection [Package Insert]. North Chicago, IL: AbbVie Inc.
- HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://ec.europa.eu/health/documents/community-register/2016/20160624135201/anx_135201_en.pdf. Last updated November 28, 2016. Accessed February 16, 2017.
SOURCE: AbbVie
Post Views: 54
