Hidradenitis Suppurativa
Conditions
Keywords
hidradenitis suppurativa, anakinra
Brief summary
This is an open-label, proof-of-concept research study to assess the effectiveness of anakinra in the treatment of patients with hidradenitis suppurativa (HS). The planned intervention is to provide about 6 HS patients with anakinra 100mg daily injections to administer subcutaneously for 8 weeks. Then, the study subjects will be followed for a further 8 weeks to monitor for relapse of HS.
Interventions
DRUGanakinra
Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
Sponsors
University of California, San Francisco
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity
Exclusion criteria
1. Use of the following therapies: * Etanercept in the 4 weeks prior to the baseline visit (Day 1) * Adalimumab in the 8 weeks prior to the baseline visit (Day 1) * Infliximab in the 12 weeks prior to the baseline visit (Day 1) * Any other investigational biologics in the 8 weeks prior to the baseline visit (Day 1) * Leflunomide in the 4 weeks prior to the baseline visit (Day 1) • Thalidomide in the 4 weeks prior to the baseline visit (Day 1) * Cyclosporine in the 4 weeks prior to the baseline visit (Day 1) * I.V. immunoglobulin (I.V. Ig) in the 8 weeks prior to the baseline visit (Day 1) * 6-Mercaptopurine, azathioprine, cyclophosphamide, or chlorambucil in the 12 weeks prior to the baseline visit (Day 1) * Colchicine, dapsone, mycophenolate mofetil & systemic antibiotics in the 3 weeks prior to the baseline visit (Day 1) * Corticosteroids 20mg/day or \>0.4 mg/kg, whichever applies, in the 1 week prior to the baseline visit (Day 1) 2. history of immunocompromise including HIV infection 3. positive Hep B surface antigen -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Sartorius Score | Baseline, 8 weeks | At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: \< 5 cm, 1 point; 5-10 cm, 3 points; \> 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points. Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life Assessments | Baseline, 8 weeks | The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable). The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit? with a scale of 0=no acitivity to 100=maximal activity. |
| Change in Dermatology Quality of Life Index (DLQI) | Baseline, 8 weeks | Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life |
| Change in C-reactive Protein | Baseline, 8 weeks | Change assessed from baseline to end of treatment phase. |
Countries
United States
Participant flow
Recruitment details
Patients were recruited from an academic dermatology practice in San Francisco, CA; informed consent was obtained before study entry.
Pre-assignment details
11 patients were screened for inclusion. 6 were eligible and were enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Anakinra All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.
anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Active Therapy | Lost to Follow-up | 1 |
| Follow-up Off Therapy | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Anakinra |
|---|---|
| Age, Continuous | 37 years |
| Initial C-reactive protein | 30.6 mg/L STANDARD_DEVIATION 23.03 |
| Initial modified Sartorius score | 78.5 units on a scale |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Change in Modified Sartorius Score
At each study visit, the same physician (dermatologist) examined patients and recorded the following: (i) anatomical regions involved: axilla, groin, gluteal (left ⁄right) or other region, 3 points per region; (ii) numbers and scores of lesions (nodule 1 point, fistula 6 points) for each region; (iii) longest distance between two relevant lesions (or size of single lesion) in each region: \< 5 cm, 1 point; 5-10 cm, 3 points; \> 10 cm, 9 points; and (iv) whether all lesions are separated by normal skin: yes, 0; no (= Hurley III), 9 points. Regional scores were summed to a total score, ranging from 5 to indefinite. Smaller numbers are better scores and indicate less lesion involvement. Decreases (negative changes) from baseline indicate improvement in disease severity.
Time frame: Baseline, 8 weeks
Population: The 5 patients who completed 8 weeks of therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Anakinra | Change in Modified Sartorius Score | -34.8 units on a scale |
Comparison: Significance of decrease in modified Sartorius score from Baseline to 8 weeksp-value: 0.024t-test, 2 sided
Secondary
Change in C-reactive Protein
Change assessed from baseline to end of treatment phase.
Time frame: Baseline, 8 weeks
Population: Patients who completed 8 weeks of therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Anakinra | Change in C-reactive Protein | -16.7 mg/L |
Secondary
Change in Dermatology Quality of Life Index (DLQI)
Patient self-administered questionnaire measuring the extent to which disease affects quality of life, range 0-30, with higher score reflecting a larger negative effect of disease on quality of life
Time frame: Baseline, 8 weeks
Population: Patients who completed 8 weeks of therapy
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Anakinra | Change in Dermatology Quality of Life Index (DLQI) | -8.4 units on a scale |
Secondary
Change in Quality of Life Assessments
The Physician Global Assessment: The physician assessed disease activity on the visual analog scale ranging from 0mm (absent) to 100mm (worst imaginable). The Patient Global Assessment; The patients reported overall (global) disease activity of HS. Patients were asked What is the overall activity (pain, discharge, odor, and presence of new lesions) of hidradenitis at this visit? with a scale of 0=no acitivity to 100=maximal activity.
Time frame: Baseline, 8 weeks
Population: Patients who completed 8 weeks of therapy
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Anakinra | Change in Quality of Life Assessments | Physician Global Assessment | -45.8 units on a scale |
| Anakinra | Change in Quality of Life Assessments | Patient Global Assessment | -35.6 units on a scale |
Comparison: Significance of reductions in Physican Global Assessment mean values between baseline and 8 weeks of therapyp-value: 0.006t-test, 2 sided
Comparison: Significance of reductions in Patient Global Assessment mean values between baseline and 8 weeks of therapyp-value: 0.019t-test, 2 sided