update on hidradenitis - departmentofmedicine.com€¦ · hidradenitis suppurativa. rev endocr...
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Update on Hidradenitis
Connie Zhang, MD, FRCPCNov 3, 2018
CSM 13th Annual Day in Dermatology for Family Physicians
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Faculty/Presenter Disclosure
• Faculty: Connie Zhang
• Relationships with financial sponsors:– None to disclose
• No financial support or conflicts of interest to disclose
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Disclosure of Financial Support• This program has received financial support from:
Abbvie, Actelion, Celgene, Cipher, Galderma, Hill Dermaceuticals Inc, InVentiv Health, Janssen, Leo, Novartis, Pfizer, Pierre Fabre, Sanofi Genzyme, Valeant
in the form of unrestricted educational grants
• Potential for conflict(s) of interest:No conflicts of interest with pharmaceutical companies, pharmaceutical products or pharmaceutical companies providing unrestricted educational grants for this program.
CFPC CoI Templates: Slide 2
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Mitigating Potential Bias
• Whenever possible, generic drugs names willbe used. However some trade names will bementioned.
• Whenever possible, therapeutic suggestionswill be evidence based. However, sometherapeutics suggestions may be off label.
CFPC CoI Templates: Slide 3
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Pre-quiz1. In a patient with HS, what systemic co-
morbidities are important to monitor for?2. What is the first-line topical treatment for
mild disease?3. What is the first-line systemic treatment?4. What is the first drug specifically approved by
the US FDA for the treatment of HS?
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BACKGROUND
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“The word boil provides cultural connotations that play a significant role in the perception of the disease – think of the bubonic plague or the Book of Job. Culturally and
in all societies of man, boils are known examples of unclean, contagious signs of divine punishment.” –
Gregor Jemec, MD, DMSCi
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“[HS] has historically been treated by a great number of different specialities, but owned by none: surgeons, emergency physicians, plastic surgeons, infectious
disease specialists, general practitioners, and dermatologists.” – Gregor Jemec, MD, DMSCi & Alexa
Kimball, MD, MPH
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Hidradenitis suppurativa – disease burden
• Pruritus• Pain• Discharge• Substantial disability• Social stigma• Sexual health
• Depression• Anxiety• Diminished QoL• Decreased work
productivity• Numerous medical co-
morbidities
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HS Epidemiology
• 0.05-4.10%• Typically post-pubertal onset• F:M 2-5:1• Mean delay of diagnosis – 7.2 years
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DIAGNOSIS
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Hidradenitis suppurativa
• 3 criteria for diagnosis:1. Lesion morphology2. Distribution3. Chronic recurrent course
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Hidradenitis suppurativa
• 3 criteria for diagnosis (modified Dessau def):1. Lesion morphology
– Nodules, abscesses, tunnels, scars
2. Distribution– Intertriginous folds
3. Chronic recurrent course– 2 recurrences within 6 months OR– Persistent lesions for 3 months
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A few more clues to diagnosis
• Family history• Absence of pathogenic microbes on culture• History of pilonidal sinus• Non-characteristic lesions in typical locations
– Eg folliculitis, open comedones
• Typical lesions in atypical locations– Eg pressure points on belt region of abdomen
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Newer scoring systems
• mSS – modified Sartorius Score• HS-PGA – HS-Physician’s Global Assessment• HSSI – HS severity index• HiSCR – Hidradenitis Suppurativa Clinical
Response
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HiSCR
• >50% reduction in inflammatory (transient) lesion count (sum of abscesses and nodules) and no increase in abscesses or draining fistulas (chronic inflamed lesions) when compared with baseline
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HiSCR
• Responsive, clinically meaningful• Test-retest reliability, convergent validity,
responsiveness, predictive validity confirmed• Validated against patient-reported outcomes
– Pain, DLQI, work/activity impairment
• Correlated with improvements in Hurley stage, mSS, HS-PGA
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COMORBIDITIES
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US claims data analysis
• Retrospective matched cohort study• Two severity cohorts (HS-mild and HS-severe)
based on treatments received• 5357 total patients with HS matched to HS-
free controls• Found that comorbidity burden increases with
disease severity
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Endocrine/metabolic disorders
• Obesity: 11.3% (HS-S) vs 2.6% (control)• Diabetes: 19.2% (HS-S) vs 6.0% (control)• PCOS: 2.0% (HS-S) vs 0.6% (control)• HTN: 33.4% (HS-S) vs 17.4% (control)• Dyslipidemia: 30.7% (HS-S) vs 18.7% (control)• Thyroid disease: 12.0% (HS-S) vs 7.8%
(control)
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Other comorbidities
• Asthma: 9.8% (HS-S) vs 4.8% (control)• Anemia: 11.1% (HS-S) vs 4.4% (control)• Depression: 14.4% (HS-S) vs 7.2% (control)• Anxiety: 9.2% (HS-S) vs 5.9% (control)• Kidney disease: 3.1% (HS-S) vs 0.5% (control)• Non-cutaneous cancers: 4.6% (HS-S) vs 2.1%
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Yet more comorbidities (at least two-fold increase in prevalence)
• COPD• Valvular disease• Psychoses• Substance abuse• Sleep-wake disorders• Fluid and electrolyte
disorders• Congestive heart failure
• Liver disease• Peripheral vascular
disorder• Weight loss• Other neurological
disorders
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Literature review
• Most convincing association with obesity & the metabolic syndrome
• Other links not reported in US claims analysis:– Smoking – 40-92% rate of smoking in HS patients– Inflammatory bowel disease – Spondyloarthropathy, arthritis (HLA-B27 negative)– Pyoderma gangrenosum (PASH, PAPASH, PsAPASH)– SCC – 0.5-4.6% rate in HS – aggressive, ++ mets
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MEDICAL THERAPY
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Therapeutic goals
• Alleviate pain• Minimize inflammation, scarring• Prevent disease progression• Delay the need for surgery
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Traditional Framework
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European guidelines
1. Diagnosis should be made by dermatologist or other healthcare professional with expert knowledge in HS.
2. Adjuvant therapy: pain mgmt., weight loss, tobacco cessation, treat infections, wound care & dressings.
3. Need for surgical intervention should be assessed and evidence-based surgical approach should be implemented.
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European guidelines
4. Mild disease: topical clindamycin 1% solution/gel BID x 12 weeks OR tetracycline 500mg PO BID x 4 months
5. Mod-severe: clindamycin 300mg PO BID + rifampicin 600mg PO OD x 10 weeks
6. If no response: adalimumab 40mg SC inj weekly
7. If no response after 16 weeks: 2nd or 3rd line therapy
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European guidelines
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3rd line: anakinra (IL-1), ustekinumab (p40), dapsone, acitretin
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Adalimumab
• Recombinant human IgG1 anti-TNF monoclonal antibody
• Blocks TNF-α• FDA approval Sept 2015 – mod-severe HS• PIONEER I, II, OLE• Dosing: 160mg SC week 0, 80mg week 2,
40mg week 4 and weekly thereafter
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PIONEER I & II
• Phase III multicenter, double-blind, randomized placebo-controlled trials
• PIONEER I (n=307), PIONEER II (n=326)• Primary outcome: HiSCR-50 with no increase
in abscess or fistula count from baseline, at week 12
• 41.8% vs 26.0% in PIONEER I (P=0.003)• 58.9% vs 27.6% in PIONEER II (P<0.001)
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PIONEER I & II
• Secondary outcomes:– Lesions – total abscess/nodule count of 0, 1, or 2– Pain – 30% and at least 1-unit reduction in 10-pt
scale score– Modified Sartorius Score – change from baseline
• Significantly greater improvement in secondary outcomes in PIONEER II only
• Rate of serious adverse events similar between groups
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INTEGRATED ANALYSIS HiSCR Rate During Period 1 of PIONEER I & II Studies (NRI)
*Statistically significant with p-value less or equal to 0.05Kimball AB, et al. Evaluating Optimal Medium-Term Dosing Strategy For Adalimumab In Patients With Moderate–To-Severe Hidradenitis Suppurativa Based On Analysis Of Integrated Results From The PIONEER I And II Phase 3 .AAD congress 2015 San Francisco, F010.
60%
50%
40%
30%
20%
10%
0%Week 0 Week 2 Week 4 Week 8 Week 12
% o
f Sub
ject
s
EW (N=316)PBO (N=317)
*40.8%
*48.1%
*34.5%
12.9%
20.5%
*50.6%
22.7%26.8%
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PIONEER OLE
A sustained response is seen through week 168 in 52.3% of patients treated with adalimumab, 40 mg weekly, with no
additional safety issues identified.
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Surgical & light-based therapies
• Incision & drainage• Wide excision• Local excision or tissue-
saving methods• Electrosurgery• Cryosurgery
• Nd:YAG laser• CO2 laser• Intense pulsed light• Photodynamic therapy
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1st line
• Topicals– Dressings, ice packs,
diclofenac gel 1%, xylocaine ung 5%, ketamine 10%, bupivacaine 1%, doxepin 3%, gabapentin 6%
• Acetaminophen• NSAIDs
2nd line
• Oral opiates• Anticonvulsants• SSRIs• SNRIs
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Post-quiz1. In a patient with HS, what systemic co-
morbidities are important to monitor for?2. What is the first-line topical treatment for
mild disease?3. What is the first-line systemic treatment?4. What is the first drug specifically approved by
the US FDA for the treatment of HS?
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Take Home Points
• Consider HS early on in the presentation of recurrent painful nodules and abscesses that scar, in the typical distribution of the intertriginous folds
• Be aware of systemic disease associations particularly the metabolic syndrome, hormonal disorders, and psychosocial sequelae
• In the management of HS, oral antibiotics are first-line among systemic therapies and biologics are supported by the highest-quality evidence; pain management is an important adjunct
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References• Alhusayen R, Shear NH. Scientific evidence for the use of current traditional systemic
therapies in patients with hidradenitis suppurativa. J Am Acad Dermatol. 2015 Nov;73(5 Suppl 1):S42-6.
• Blok JL, Li K, Brodmerkel C, Horvátovich P, Jonkman MF, Horváth B. Ustekinumab in hidradenitis suppurativa: clinical results and a search for potential biomarkers in serum. Br J Dermatol. 2016 Apr;174(4):839-46.
• Bolognia JL, Schafer JV, Cerroni L. (2018). Dermatology 4th Ed: Elsevier.• Gulliver W, Zouboulis CC, Prens E, Jemec GB, Tzellos T. Evidence-based approach to the
treatment of hidradenitis suppurativa/acne inversa, based on the European guidelines for hidradenitis suppurativa. Rev Endocr Metab Disord. 2016 Sep;17(3):343-351.
• Houriet C, Jafari S, Thomi R. Canakinumab for severe hidradenitis suppurativa: Preliminary experience in 2 cases. JAMA Dermatol. 2017;153(11):1195-1197.
• Kimball AB, Okun MM, Williams DA et al. Two Phase 3 Trials of Adalimumab for Hidradenitis Suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34.
• Kohorst JJ, Baum CL, Otley CC et al. Surgical Management of Hidradenitis Suppurativa: Outcomes of 590 Consecutive Patients. Dermatol Surg. 2016 Sep;42(9):1030-40.
• Saunte DML, Jemec GBE. Hidradenitis Suppurativa: Advances in Diagnosis and Treatment. JAMA. 2017 Nov 28;318(20):2019-2032.
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Anakinra
• Recombinant IL-1R antagonist – inhibits binding of IL-1α and IL-1β to receptors
• RCT of 20 patients – 100mg SC daily achieved HiSCR-50 of 30% of placebo group vs 78% of treatment group at the end of 12 weeks
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Ustekinumab
• Human IgG1κ monoclonal antibody – binds p40 subunit of IL-12 and IL-23
• Prospective, uncontrolled, open-label study (n=17): 47% achieved HiSCR-50 at week 40, 82% had moderate to marked improvement of the mSS