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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anakinra | Experimental | All patients in this arm will receive the investigation drug anakinra once daily subcutaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anakinra | Drug | Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
1) Signed informed consent form with Confirmed diagnosis of hidradenitis suppurativa with moderate or severe disease activity
Exclusion Criteria:
Use of the following therapies:
history of immunocompromise including HIV infection
positive Hep B surface antigen -
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| Name | Affiliation | Role |
|---|---|---|
| Kieron S Leslie, M.D. | University of California, San Francisco - Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco General Hospital | San Francisco | California | 94110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18674845 | Background | Revuz JE, Canoui-Poitrine F, Wolkenstein P, Viallette C, Gabison G, Pouget F, Poli F, Faye O, Roujeau JC, Bonnelye G, Grob JJ, Bastuji-Garin S. Prevalence and factors associated with hidradenitis suppurativa: results from two case-control studies. J Am Acad Dermatol. 2008 Oct;59(4):596-601. doi: 10.1016/j.jaad.2008.06.020. | |
| 2934550 |
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11 patients were screened for inclusion. 6 were eligible and were enrolled.
Patients were recruited from an academic dermatology practice in San Francisco, CA; informed consent was obtained before study entry.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Active Therapy |
|
| ||||||||||||||||||
| Follow-up Off Therapy |
|
Eligible per protocol criteria
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The 5 patients who completed 8 weeks of therapy | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 8 weeks |
|
16 weeks: 8 weeks of study therapy, followed by an additional 8 weeks of follow-up off therapy
Vital signs and physical examinations were undertaken at every visit. The investigators assessed adverse events throughout the study by direct patient query, observation by study personnel, and spontaneous patient reporting.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Painful injection site | Skin and subcutaneous tissue disorders | Systematic Assessment | All patients reported painful injection site reactions, which decreased in severity after a few weeks of treatment. |
Limitations of the study include early termination leading to small numbers of subjects analyzed, and lack of control group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kieron S. Leslie, MD | University of California, San Francisco | 415-206-4777 | lesliek@derm.ucsf.edu |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
| Baseline, 8 weeks |
| 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 | Baseline, 8 weeks |
| Change in C-reactive Protein | Change assessed from baseline to end of treatment phase. | Baseline, 8 weeks |
| Fitzsimmons JS, Guilbert PR. A family study of hidradenitis suppurativa. J Med Genet. 1985 Oct;22(5):367-73. doi: 10.1136/jmg.22.5.367. |
| 16093838 | Background | Stojanov S, Kastner DL. Familial autoinflammatory diseases: genetics, pathogenesis and treatment. Curr Opin Rheumatol. 2005 Sep;17(5):586-99. doi: 10.1097/bor.0000174210.78449.6b. |
| 17039195 | Background | Steinhoff JP, Cilursu A, Falasca GF, Guzman L, Reginato AJ. A study of musculoskeletal manifestations in 12 patients with SAPHO syndrome. J Clin Rheumatol. 2002 Feb;8(1):13-22. doi: 10.1097/00124743-200202000-00005. |
| 15897171 | Background | Rosi YL, Lowe L, Kang S. Treatment of hidradenitis suppurativa with infliximab in a patient with Crohn's disease. J Dermatolog Treat. 2005 Feb;16(1):58-61. doi: 10.1080/09546630410024547. |
| 18241264 | Background | Hunger RE, Surovy AM, Hassan AS, Braathen LR, Yawalkar N. Toll-like receptor 2 is highly expressed in lesions of acne inversa and colocalizes with C-type lectin receptor. Br J Dermatol. 2008 Apr;158(4):691-7. doi: 10.1111/j.1365-2133.2007.08425.x. Epub 2008 Jan 30. |
| 15125785 | Background | Sakai A, Han J, Cato AC, Akira S, Li JD. Glucocorticoids synergize with IL-1beta to induce TLR2 expression via MAP Kinase Phosphatase-1-dependent dual Inhibition of MAPK JNK and p38 in epithelial cells. BMC Mol Biol. 2004 May 4;5:2. doi: 10.1186/1471-2199-5-2. |
| 17178985 | Background | Leslie KS, Lachmann HJ, Bruning E, McGrath JA, Bybee A, Gallimore JR, Roberts PF, Woo P, Grattan CE, Hawkins PN. Phenotype, genotype, and sustained response to anakinra in 22 patients with autoinflammatory disease associated with CIAS-1/NALP3 mutations. Arch Dermatol. 2006 Dec;142(12):1591-7. doi: 10.1001/archderm.142.12.1591. |
| 19438453 | Background | Sartorius K, Emtestam L, Jemec GB, Lapins J. Objective scoring of hidradenitis suppurativa reflecting the role of tobacco smoking and obesity. Br J Dermatol. 2009 Oct;161(4):831-9. doi: 10.1111/j.1365-2133.2009.09198.x. Epub 2009 Apr 29. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Initial modified Sartorius score | The following are recorded by the dermatologist: (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 lesion if single) 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 are added and summed up to the patient's total score. The upper limit of the scale is open. | Mean | Full Range | units on a scale |
|
| Initial C-reactive protein | Normal <3.1 mg/L | Mean | Standard Deviation | mg/L |
|
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. |
|
|
|
| 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. | Patients who completed 8 weeks of therapy | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 8 weeks |
|
|
|
|
| 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 | Patients who completed 8 weeks of therapy | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 8 weeks |
|
|
|
| Secondary | Change in C-reactive Protein | Change assessed from baseline to end of treatment phase. | Patients who completed 8 weeks of therapy | Posted | Mean | 95% Confidence Interval | mg/L | Baseline, 8 weeks |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
|
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| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
| D011506 | Proteins |
| D001685 | Biological Factors |
| t-test, 2 sided |
| 0.019 |
Significance was accepted at p<0.05 |
| No |
| Superiority or Other |