Anakinra as a Treatment for Hydradenitis Suppurativa

• ClinicalTrials.gov Identifier: NCT01516749
• Recruitment Status: Completed
• First Posted: January 25, 2012
• Results First Posted: August 6, 2014
• Last Update Posted: August 20, 2014
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hidradenitis Suppurativa	Drug: anakinra	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Non-randomized Study Assessing the Efficacy and Tolerability of Fixed-dose Regimen Daily Subcutaneous Anakinra for the Treatment of Moderate to Severe Hidradenitis Suppurativa
• Study Start Date: October 2012
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Anakinra; All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.	Drug: 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.; Other Name: Kineret[TM]

Outcome Measures

Primary Outcome Measures :

1. Change in Modified Sartorius Score [ Time Frame: 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 Outcome Measures :

1. Change in Quality of Life Assessments [ Time Frame: 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.

2. Change in Dermatology Quality of Life Index (DLQI) [ Time Frame: 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
3. Change in C-reactive Protein [ Time Frame: Baseline, 8 weeks ]
   Change assessed from baseline to end of treatment phase.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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 -

Contacts and Locations

Locations

United States, California

San Francisco General Hospital

San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Kieron S Leslie, M.D.; University of California, San Francisco - Department of Dermatology

More Information

Publications:

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.

Fitzsimmons JS, Guilbert PR. A family study of hidradenitis suppurativa. J Med Genet. 1985 Oct;22(5):367-73.

Stojanov S, Kastner DL. Familial autoinflammatory diseases: genetics, pathogenesis and treatment. Curr Opin Rheumatol. 2005 Sep;17(5):586-99. Review.

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.

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.

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.

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.

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.

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.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT01516749
• Other Study ID Numbers: 11-08101
• First Posted: January 25, 2012
• Results First Posted: August 6, 2014
• Last Update Posted: August 20, 2014
• Last Verified: August 2014

Keywords provided by University of California, San Francisco:

hidradenitis suppurativa; anakinra

Additional relevant MeSH terms:

Hidradenitis Suppurativa; Hidradenitis; Sweat Gland Diseases; Skin Diseases; Skin Diseases, Bacterial; Bacterial Infections; Skin Diseases, Infectious; Infection; Suppuration; Interleukin 1 Receptor Antagonist Protein; Antirheumatic Agents