conventional systemic HS therapy. US 10 November Approved on 09 Humira is indicated for the 2014 September 2015 treatment of moderate to severe hidradenitis suppurativa. Canada 14 January Approved on 31 Humira is indicated for the 2015 December 2015 treatment of active moderate to severe hidradenitis suppurativa in patients, who have not responded to conventional therapy (including systemic antibiotics). Product Information The Product Information (PI) approved with the submission which is described in this AusPAR can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings There was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings A summary of the clinical findings is presented in this section. Further details of clinical findings can be found in Attachment 2. Clinical rationale Hidradenitis suppurativa (HS) is a debilitating, chronic inflammatory follicular disease characterised by the formation of recurrent abscesses, inflammatory nodules, and fistulas. It mainly involves skin regions with apocrine glands such as axillae, groins, perineal and perianal areas, and submammary areas. Lesions are often painful and result in malodorous discharge. Complications include excessive scarring and fibrosis potentially leading to contractures and limitations in mobility, as well as anal, urethral, and rectal strictures. Other comorbidities associated with HS include anaemia, secondary infection, malignancy (such as non–melanoma skin cancer [NMSC]), depression, and anxiety. These disease sequelae result in significant reduction of health related quality of life in affected individuals. The estimated prevalence of HS is approximately 1%. The disease onset is typically in the second and third decade of life and is rare in prepubertal children. Women are affected more commonly than men (female/male ratio approximately 2:1). Predisposing factors include obesity and cigarette smoking. The diagnosis is usually established based on the
conventional systemic HS therapy. US 10 November 2014 Approved on 09 September 2015 Humira is indicated for the treatment of moderate to severe hidradenitis suppurativa. Canada 14 January 2015 Approved on 31 December 2015 Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa in patients, who have not responded to conventional therapy (including systemic antibiotics). Product Information The Product Information (PI) approved with the submission which is described in this AusPAR can be found as Attachment 1. For the most recent PI, please refer to the TGA website at <>. II. Quality findings There was no requirement for a quality evaluation in a submission of this type. III. Nonclinical findings There was no requirement for a nonclinical evaluation in a submission of this type. IV. Clinical findings A summary of the clinical findings is presented in this section. Further details of clinical findings can be found in Attachment 2. Clinical rationale Hidradenitis suppurativa (HS) is a debilitating, chronic inflammatory follicular disease characterised by the formation of recurrent abscesses, inflammatory nodules, and fistulas. It mainly involves skin regions with apocrine glands such as axillae, groins, perineal and perianal areas, and submammary areas. Lesions are often painful and result in malodorous discharge. Complications include excessive scarring and fibrosis potentially leading to contractures and limitations in mobility, as well as anal, urethral, and rectal strictures. Other comorbidities associated with HS include anaemia, secondary infection, malignancy (such as non–melanoma skin cancer [NMSC]), depression, and anxiety. These disease sequelae result in significant reduction of health related quality of life in affected individuals. The estimated prevalence of HS is approximately 1%. The disease onset is typically in the second and third decade of life and is rare in prepubertal children. Women are affected more commonly than men (female/male ratio approximately 2:1). Predisposing factors include obesity and cigarette smoking. The diagnosis is usually established based on the
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