Acta Dermato-Venereologica 98-10CompleteContent | Page 7
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CLINICAL REPORT
Achieving Hidradenitis Suppurativa Response Score is Associated
with Significant Improvement in Clinical and Patient-reported
Outcomes: Post Hoc Analysis of Pooled Data From PIONEER I and II
Alexandra Boer KIMBALL 1 , Thrasivoulos TZELLOS 2,3 , Brian M. CALIMLIM 4 , Henrique D. TEIXEIRA 4 , Ziqian GENG 4 and
Martin M. OKUN 5
Harvard Medical School and Beth Israel Deaconess Hospital, Boston, Massachusetts, USA, 2 Department of Dermatology, Faculty of Health
Sciences, University Hospital of North Norway, 3 Institute of Clinical Medicine, Arctic University, Tromsø, Norway, 4 AbbVie Inc., North Chicago,
Illinois, and 5 Fort HealthCare, Fort Atkinson, Wisconsin, USA
1
Hidradenitis Suppurativa Clinical Response (HiSCR), is
a validated tool that has been used to assess the efficacy
of adalimumab among patients with hidradenitis sup-
purativa. We evaluated the clinical meaning of HiSCR
by relating it to patient-reported outcomes to give
further context to its achievement in a post hoc ana-
lysis of integrated data from two phase 3 clinical trials
(PIONEER I and II). Pooling placebo and active treat-
ment arms, 39% of patients (245/629) achieved HiSCR
at week 12. Irrespective of treatment, significantly
(p < 0.05) more HiSCR responders than non-respon-
ders experienced clinically meaningful improvement
in Dermatology Life Quality Index (60.5% vs 30.4%),
Pain Numeric Rating Scale (46.9% vs 19.9%), hidra-
denitis suppurativa quality of life (49.4% vs 26.9%),
work-related performance (52.6% vs 37.7%), and
non-work-related performance (59.5% vs 33.3%).
Clinically meaningful outcomes in hidradenitis suppu-
rativa are more likely to be attained in patients achie-
ving HiSCR level improvement.
Key words: abscess; inflammatory nodule; DLQI; PIONEER I;
PIONEER II; minimum clinically important difference.
Accepted Jul 27, 2018; Epub ahed of print Aug 7, 2018
Acta Derm Venereol 2018; 98: 932–937
Corr: Brian M. Calimlim, DrPH, MS, Dept GMH1, AbbVie Inc., 1 N Waukegan
Road, North Chicago, IL 60064, USA. E-mail: [email protected]
H
idradenitis suppurativa (HS), or acne inversa, is
a chronic skin disease characterized by recur-
rent inflammation and deep‐seated lesions in apocrine
gland‐bearing, intertriginous areas of the body (1–3). The
reported prevalence of HS varies widely from 0.03% to
8%, depending on the setting and methodology used (4),
but may be underreported, as the average time from first
symptoms to diagnosis is 7 years (5). HS can cause scar-
ring and disability (6, 7) and substantially affects patient
health-related quality of life (HRQL) outcomes (8–11).
Available clinical measures for assessing HS disease
severity include Hurley stage, modified Sartorius score,
and the HS Physician’s Global Assessment (12–15);
however, none of these measures have been validated in
depth regarding clinical and patient relevance and impact.
HS clinical response (HiSCR) (16) is a validated tool
that has been used to assess treatment efficacy in clinical
doi: 10.2340/00015555-3012
Acta Derm Venereol 2018; 98: 932–937
SIGNIFICANCE
Hidradenitis suppurativa is a chronic skin disease cha-
racterized by inflammation and deep-seated lesions. The
hidradenitis suppurativa clinical response (called HiSCR) is
a straightforward and well-validated tool designed to as-
sess treatment response. It is based on the counts of easily
recognizable clinical signs of hidradenitis suppurativa, in-
cluding inflammatory nodules, abscesses, and draining fis-
tulas. This study verifies that the HiSCR is a reliable tool for
assessing clinically meaningful improvements in inflamma-
tory signs and symptoms of hidradenitis suppurativa and
improving health outcomes from the patient’s perspective.
Given these characteristics, the HiSCR is appropriate for
use in clinical trials and clinical care.
trials. HiSCR is designed to be a practical measure and
is based on counts of easily recognizable clinical signs,
including inflammatory nodules, abscesses, and draining
fistulas. The HiSCR was designed based on data from a
phase 2 clinical trial in patients with HS and retrospec-
tively tested in that data set (16, 17). Phase 3 clinical
trials (PIONEER I and II) (18) assessing the effect of
adalimumab (ADA) on HS subsequently used HiSCR
as a measure of treatment response and ultimately led
to approval by the US Food and Drug Administration
(FDA) for the treatment of moderate to severe HS in
adult patients, and by the European Medicines Agency
(EMA) for the treatment of active moderate to severe
HS in adult patients who have failed to respond to con-
ventional systemic therapies.
A recent systematic review (19) of HS outcome mea-
sures concluded that good-quality validation evidence
is available for the HiSCR instrument, making HiSCR
an appropriate tool to use to assess anti-inflammatory
treatment effect in HS. The Ingram review (19) noted
that evidence of association between HiSCR and mini-
mum clinically important difference (MCID) in various
outcomes was lacking. Therefore, the objective of this
post hoc analysis was to further validate and assess
the association of HiSCR with manifestations of HS
commonly seen in the clinical setting and measures of
HRQL, irrespective of treatment in combined data from
two phase 3 randomized, controlled, double-blind trials
This is an open access article under the CC BY-NC license. www.medicaljournals.se/acta
Journal Compilation © 2018 Acta Dermato-Venereologica.