Long Term Observational Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe HS Within the Italian Population (ANIMA - Italy)

Long Term Observational, Prospective, Multicenter Study to Collect in a Real-world populatIon Data on the Treatment Pattern of Secukinumab in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) Within the Italian Population (ANIMA - Italy)

The aim of this study is to generate real-world evidence to fill knowledge gaps regarding the response to secukinumab in patients with moderate to severe HS, its treatment patterns, the clinical characteristics of patients on secukinumab, healthcare resource utilization and the economic impact of HS in Italy.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Italy
  • Naples, Italy, 80131
    • Recruiting
    • Novartis Investigative Site
  • AN
    • Ancona, AN, Italy, 60126
      • Recruiting
      • Novartis Investigative Site
  • BS
    • Brescia, BS, Italy, 25123
      • Recruiting
      • Novartis Investigative Site
  • FE
    • Cona, FE, Italy, 44124
      • Recruiting
      • Novartis Investigative Site
  • FI
    • Florence, FI, Italy, 50122
      • Recruiting
      • Novartis Investigative Site
  • GE
    • Genova, GE, Italy, 16132
      • Recruiting
      • Novartis Investigative Site
  • LE
    • Lecce, LE, Italy, 73100
      • Recruiting
      • Novartis Investigative Site
  • ME
    • Messina, ME, Italy, 98125
      • Recruiting
      • Novartis Investigative Site
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • Novartis Investigative Site
    • San Donato Milanese, MI, Italy, 20097
      • Recruiting
      • Novartis Investigative Site
  • TN
    • Trento, TN, Italy, 38100
      • Recruiting
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include male and female adult patients (aged ≥ 18 years) with a diagnosis of moderate or severe HS and initiating treatment with secukinumab according to clinical practice

Description

Inclusion Criteria:

Study participants eligible for inclusion in this study must meet all the following criteria:

1. Male and Female patients who provide written informed consent and privacy form (ICF&PF) to participate in the study.

2. Aged ≥ 18 years at ICF&PF signature. 3. Patients with moderate or severe HS (IHS4 and/or Hurley staging system, as assessed by the investigators) at index date.

4. The start of secukinumab is within 30 days after the ICF&PF signature (enrolment), as per local standard clinical practice. Patients were not treated with secukinumab before enrolment within the Managed Access Program (MAP). The initiation of secukinumab is based on dermatologist's own practice, regardless of study participation.

For HRU and economic burden only:

5. Patients who provide written ICF&PF to allow the use of secondary (administrative) data for the purposes of this study.

6. Patients with more than 12 months of residence inside the area of competence of the LHU (applicable only to study sites associated with the 6 LHUs).

Exclusion Criteria:

Study participants meeting any of the following criteria are not eligible for inclusion in this study:

7. Participation in an ongoing clinical trial. 8. Any medical or psychological condition that may prevent study participation, based on practitioners' decision-making.

For HRU and economic burden only:

9. Patients will be excluded if the unique identifier does not allow them to be identified in the LHU administrative databases related to the site where they were enrolled.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) during the observational period.	Proportion of patients achieving International Hidradenitis Suppurativa Severity Score System 55% reduction(IHS4-55) during the observational period. The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS	Baseline,6 months and 1 and 1,5 years after initiation of secukinumab

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing	The proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing (q4w / q2w regimen), at 6 months, 1 and 1.5 years after initiation of secukinumab treatment. The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS	6 months, 1 and 1.5 years after initiation of secukinumab treatment
Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)	The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS	6 months, 1 and 1.5 years after initiation of secukinumab treatment
Proportion of patients achieving 50% reduction in HiSCR (HiSCR-50) and 75% reduction in HiSCR (HiSCR-75)	The Hidradenitis Suppurativa Clinical Response (HiSCR) is defined as a ≥ 50% reduction in total AN count (abscesses + inflammatory nodules), and no increase in abscesses or draining tunnels when compared with baseline.	6 months, 1 and 1.5 years after initiation of secukinumab treatment
Number, type, and localization of HS lesions	lesion spread is defined as total abscess and inflammatory nodule count (AN) or draining fistulae in a body region not seen at baseline	baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment
Change of total abscess and inflammatory nodule count		6 months, 1 and 1.5 years after initiation of secukinumab treatment
Proportion of patients receiving up-titration	Proportion of patients receiving up-titration (q4w-to-q2w) of secukinumab	Within 6 months, 1 and 1.5 years after initiation of secukinumab treatment
Proportion of patients receiving down-titration	Proportion of patients receiving down-titration (q2w-to-q4w) of secukinumab	within 6 months, 1 and 1.5 years after initiation of secukinumab treatment
Time to up-titration and down-titration	Time to up-titration (q4w-to-q2w) and down-titration (q2w-to-q4w) of secukinumab	Up to 1.5 years
Proportion of patients switching from q4w to q2w treatment	Proportion of patients switching from q4w to q2w treatment with secukinumab after dose reduction.	6 months and 1.5 years after initiation of secukinumab treatment
Proportion of patients who receive more than one up- and/or down-titration	Proportion of patients who receive more than one up- and/or down-titration of secukinumab	within 6 months, 1 and 1.5 years after initiation of secukinumab treatment
Demographics of adult patients with moderate or severe HS	Descriptive statistics will be performed	Baseline
Proportion of patients achieving a 5-point reduction of Dermatology life quality index (DLQI) score.	The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score ranges from 0 to 30, with higher scores indicating greater HRQoL impairment	6 months, 1 and 1.5 years after initiation of secukinumab treatment
Change in DLQI score from baseline	The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. The recall period is the last week. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score ranges from 0 to 30, with higher scores indicating greater HRQoL impairment	Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab
Clinical characteristics of adult patients with moderate to severe HS	Clinical characteristics of adult patients with HS moderate or severe	Up to 1.5 years
Proportion of patients with new draining tunnel	Proportion of patients with new draining tunnel(s) (fistulae/sinuses)	6 months, 1 and 1.5 years after initiation of secukinumab treatment
Number of areas affected and proportion of patients with additional area involvement		6 months, 1 and 1.5 years after initiation of secukinumab treatment
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab	Proportion of patient as per clinical practice	Up to 1.5 years
Time of initiation of concomitant medications	Time of initiation of concomitant medications (after the initiation of secukinumab)	Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment
Duration of treatment with concomitant medications	Duration of treatment with concomitant medications in a flexible dosing regimen of secukinumab	Up to 1.5 years
Proportion of patients undergoing tapering of concomitant medications	Proportion of patients undergoing tapering of concomitant medications in a flexible dosing regimen of secukinumab.	Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment
Number and type of surgical interventions	number and type of surgical interventions (minor and major surgical excision; inpatient, outpatient, or self-treatment at home) in a flexible dosing regimen of secukinumab (q4w and q2w)	6 months, 1 and 1.5 years after initiation of secukinumab
Reason for surgical intervention		Up to 1.5 years after initiation of secukinumab
Duration of discontinuation/pause of secukinumab treatment before surgery		Up to 1.5 years after initiation of secukinumab
Duration of discontinuation/pause of secukinumab treatment after surgery		Up to 1.5 years after initiation of secukinumab
Reduction in the number of surgical procedures		Up to 1.5 years after initiation of secukinumab
Identification of potential predictors using multivariable analysis		Up to 1.5 years after initiation of secukinumab treatment
Descriptive statistics of pain	Descriptive statistics of pain (Numerical Skin Pain Rating Scale).	6 months, 1 and 1.5 years after initiation of secukinumab treatment
Proportion of patients achieving a 30% reduction of Pain Numerical Rating scale (NRS30)	The Numerical Skin Pain Rating Scale (NRS) is a scale in which the respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her worst skin pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine).To assess this, the patient should concentrate on the worst pain that his/her skin lesions has generated during the previous 24 hours. NRS30 is a specific threshold used in the assessment of pain reduction in patients with HS. It is defined as a ≥30% and ≥2-point reduction in skin pain on the NRS.	6 months, 1 and 1.5 years after initiation of secukinumab treatment
Number of patients with secukinumab AEs in routine clinical practice	Number of patients with secukinumab adverse events (AEs) in routine clinical practice	Up to 1.5 years after initiation of secukinumab treatment
Hospital Anxiety and Depression Scale [HADS] score	The HADS is a widely used screening tool that helps to identify possible or probable instances of anxiety and depression among patients in non-psychiatric hospital settings. It consists of 14 items, with 7 items related to anxiety (HADS-A) and 7 related to depression (HADS-D), collecting how the patient was feeling in the previous week. Each item is scored from 0 to 3, leading to a maximum score of 21 for each subscale. The HADS is beneficial because it excludes somatic symptoms, which might be caused by physical health problems rather than psychological conditions. It is a quick, reliable, and valid measure that can be self-administered, making it a practical tool for clinicians.	6 months, 1 and 1.5 years after secukinumab initiation
Healthcare Resource Utilization of adult patients with HS	describe Healthcare Resource Utilization of adult patients with HS 12 months before and 12 months after secukinumab treatment initiation with administrative claims data	2 months before and 12 months after secukinumab treatment initiation
Costs of HS covered by the Italian National Health System	Costs of HS covered by the Italian National Health System (Servizio Sanitario Nazionale, SSN) with administrative Claims data	12 months before and 12 months after secukinumab treatment initiation
Direct costs not covered by the SSN and indirect costs of HS	Direct costs not covered by the SSN and indirect costs of HS evaluated through a structured interview between physicians and patients.	12 months before and 12 months after secukinumab treatment initiation
Analysis on HS-related surgeries per patient and related direct costs covered by SSN	HS-related surgeries and estimate direct costs of HS-related surgeries covered by the SSN during the period from the date of first HS diagnosis to 12 months after secukinumab treatment initiation with administrative Claims data	12 months after secukinumab treatment initiation

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: NIS; secukinumab; HS; Hidradenitis Suppurativa; LHUs
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis; Skin and Connective Tissue Diseases; Hidradenitis Suppurativa
• Other Study ID Numbers: CAIN457MIT03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO