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Hidradenitis Suppurativa Physician's Global Assessment

Physician-Reported Global Assessment

Grade hidradenitis suppurativa with the HS-PGA from counts of abscesses, draining fistulas and inflammatory nodules. Assigns the six grades from clear to very severe and evaluates the HS-PGA response against a baseline grade.

About the HS-PGA

Severity Bands

Score RangeClassification
0Clear
1Minimal
2Mild
3Moderate
4Severe
5Very severe

Clinical Background

The Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) was developed for the phase 2 adalimumab programme and published with the trial in 2012 (Kimball et al. 2012). It is a six-grade global scale, from clear (0) to very severe (5), assigned once per patient after all affected regions have been examined. Unlike the Hurley classification, which is static and describes the architecture of scarring and sinus tracts, the HS-PGA is defined entirely by the counts of active lesions at the visit, so it can change from one visit to the next.

Four lesion types are counted across all regions: non-inflammatory nodules, inflammatory nodules, abscesses and draining fistulas. Abscesses and draining fistulas are pooled into a single count. A patient with no lesions is clear, and a patient with only non-inflammatory nodules is minimal. With no abscesses or fistulas, 1 to 4 inflammatory nodules is mild and 5 or more is moderate. One abscess or fistula is mild without inflammatory nodules and moderate with any. Two to five abscesses or fistulas is moderate with fewer than 10 inflammatory nodules and severe with 10 or more, and more than five abscesses or fistulas is very severe regardless of the nodule count. This calculator applies those definitions to the entered counts and highlights the grade that is met.

The primary endpoint of the phase 2 trial was the HS-PGA response: a grade of clear, minimal or mild with at least a 2-grade improvement relative to baseline at week 16, which was reached by 17.6% of patients on weekly adalimumab and 3.9% on placebo. A post hoc analysis of the same dataset derived the Hidradenitis Suppurativa Clinical Response (HiSCR), a 50% reduction in the abscess and inflammatory nodule count with no increase in abscesses or draining fistulas (Kimball et al. 2014). In a direct comparison, HiSCR was more responsive to change than the HS-PGA response, whose stringent threshold contributed to the modest phase 2 result (Kimball et al. 2016), and HiSCR replaced it as the primary endpoint of the PIONEER phase 3 trials and of subsequent biologic programmes.

The HS-PGA remains useful as a global severity descriptor and appears as a secondary endpoint and an eligibility criterion (moderate or worse) in current trials. Its limitations follow from its design: it collapses many lesion counts into six grades, so improvements within a grade are invisible and a floor of clear is rarely reached; the pooled abscess and fistula count treats a draining tunnel like an abscess; no correspondence to Hurley stage was defined, and the trial enrolled patients across Hurley stages I to III; and a systematic review of hidradenitis suppurativa outcome measures found that only HiSCR carried good-quality validation data (Ingram et al. 2016). The IHS4 is the preferred dynamic severity score, and Hurley staging remains the standard for surgical planning (Zouboulis et al. 2015).

References

  1. Kimball AB, Kerdel F, Adams D, Mrowietz U, Gelfand JM, Gniadecki R, et al.. Adalimumab for the treatment of moderate to severe hidradenitis suppurativa: a parallel randomized trial. Ann Intern Med. 2012;157(12):846-855. doi:10.7326/0003-4819-157-12-201212180-00004
  2. Kimball AB, Jemec GB, Yang M, Kageleiry A, Signorovitch JE, Okun MM, et al.. Assessing the validity, responsiveness and meaningfulness of the Hidradenitis Suppurativa Clinical Response (HiSCR) as the clinical endpoint for hidradenitis suppurativa treatment. Br J Dermatol. 2014;171(6):1434-1442. doi:10.1111/bjd.13270
  3. Kimball AB, Sobell JM, Zouboulis CC, Gu Y, Williams DA, Sundaram M, et al.. HiSCR (Hidradenitis Suppurativa Clinical Response): a novel clinical endpoint to evaluate therapeutic outcomes in patients with hidradenitis suppurativa from the placebo-controlled portion of a phase 2 adalimumab study. J Eur Acad Dermatol Venereol. 2016;30(6):989-994. doi:10.1111/jdv.13216
  4. Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, et al.. Two phase 3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med. 2016;375(5):422-434. doi:10.1056/NEJMoa1504370
  5. Zouboulis CC, Tzellos T, Kyrgidis A, Jemec GBE, Bechara FG, Giamarellos-Bourboulis EJ, et al.. Development and validation of the International Hidradenitis Suppurativa Severity Score System (IHS4), a novel dynamic scoring system to assess HS severity. Br J Dermatol. 2017;177(5):1401-1409. doi:10.1111/bjd.15748
  6. Ingram JR, Hadjieconomou S, Piguet V. Development of core outcome sets in hidradenitis suppurativa: systematic review of outcome measure instruments to inform the process. Br J Dermatol. 2016;175(2):263-272. doi:10.1111/bjd.14475
  7. Zouboulis CC, Desai N, Emtestam L, Hunger RE, Ioannides D, Juhasz I, et al.. European S1 guideline for the treatment of hidradenitis suppurativa/acne inversa. J Eur Acad Dermatol Venereol. 2015;29(4):619-644. doi:10.1111/jdv.12966

Development

The clinical calculators on this site are free to use. They were developed in partnership by the Centre for Medical and Surgical Dermatology and Dermi(opens in a new tab), a Toronto company that makes clinical imaging software for dermatology practices, which continues to maintain them.

Frequently Asked Questions about the HS-PGA

The Hidradenitis Suppurativa Physician's Global Assessment (HS-PGA) is a six-grade global scale, from clear (0) to very severe (5), developed for the phase 2 adalimumab trial (Kimball et al. 2012). The grade is assigned from the counts of abscesses, draining fistulas, inflammatory nodules and non-inflammatory nodules across all affected regions, so it reflects active disease at the visit rather than scarring.
Abscesses and draining fistulas are pooled into one count. With none, the grade is clear (no lesions), minimal (only non-inflammatory nodules), mild (1 to 4 inflammatory nodules) or moderate (5 or more). With one abscess or fistula, the grade is mild without inflammatory nodules and moderate with any. With 2 to 5, it is moderate with fewer than 10 inflammatory nodules and severe with 10 or more. More than 5 abscesses or fistulas is very severe.
An HS-PGA response is a grade of clear, minimal or mild (0 to 2) together with an improvement of at least 2 grades from baseline. It was the primary endpoint of the phase 2 adalimumab trial, reached by 17.6% of patients on weekly dosing and 3.9% on placebo at week 16. A patient who improves from severe (4) to mild (2) has responded; a patient who improves from moderate (3) to mild (2) has not, because the improvement is only one grade.
All three are physician assessments, but they measure different things. Hurley staging is a static three-stage classification of disease architecture (abscesses, sinus tracts and scarring) used for surgical planning. The IHS4 is a continuous dynamic score that weights inflammatory nodules, abscesses and draining tunnels and is the preferred measure of severity over time. The HS-PGA converts the same lesion counts into six ordinal grades, which is easier to communicate but less sensitive to change.
HiSCR, a 50% reduction in the abscess and inflammatory nodule count with no increase in abscesses or draining fistulas, was derived from the phase 2 adalimumab data and shown to be more responsive to treatment than the HS-PGA response, which requires both a low grade and a 2-grade improvement. HiSCR became the primary endpoint of the PIONEER phase 3 trials and of later biologic programmes, while the HS-PGA is retained as a secondary endpoint and an eligibility criterion.

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