Introduction & Objectives: HiSCR is the most commonly used measure to assess treatment

effectiveness in Hidradenitis Suppurativa (HS). Recently, the IHS4-55 has been introduced, which
has the advantage of including draining tunnels in its calculation. When reporting results, many
studies solely report outcomes for patients continuing medication, potentially inflating efficacy
data by excluding discontinuations due to ineffectiveness. Moreover, both tools focus solely on
the lesion count, disregarding patients' perspectives. Our objective is to compare effectiveness
outcomes using two analysis methods: intention-to-treat and per-protocol analysis. Additionally,
we aim to examine the correlation between HiSCR and IHS4-55 with Pain NRS30, a subjective
measure of pain in HS patients.

Materials & Methods: We conducted a multicenter retrospective study. We included patients

with moderate to severe HS who initiated secukinumab for HS. Follow-up lasted for 24 weeks. The
main outcome was effectiveness, assessed by HiSCR, IHS4-55, and pain through NRS30. Analyses
were performed both on an intention-to-treat and per-protocol basis.

Results: 67 patients were included (33 men and 34 women) with a mean age of 41.55 years
(±11.94) and a mean baseline IHS4 score of 17.88 (±11.13). Before reaching week 24, 13 patients
discontinued secukinumab treatment: 7 due to worsening of HS despite treatment, 3 due to
adverse effects, and 3 due to loss to follow-up. In terms of intention-to-treat analysis, by week 24,
41.79% (28/67) of patients achieved HiSCR, and 44.78% (30/67) achieved IHS4-55. When
considering per-protocol analysis, by week 24, 62.22% (28/45) of patients achieved HiSCR, and
55.56% (30/54) achieved IHS4-55. HiSCR was not calculable in 9 patients with baseline AN <3. At
week 24, 61.22% (30/49) patients achieved NRS30. Data on pain was missing for 5 patients. Out of
the 30 patients who reached NRS30, 90% (27/30) also achieved IHS4-55, while 92% (23/25)
attained HiSCR (HiSCR was not calculable in 5 patients with baseline AN <3).

Conclusion: based on these findings, excluding patients who discontinue secukinumab for any
reason, as well as those with a baseline AN <3 where HiSCR is not calculable, may lead to
potentially inflated effectiveness results compared to analyzing all patients initiating treatment.
Moreover, our study reveals a strong correlation between objective outcomes noted by physicians
(inflammatory lesion count) and subjective outcomes reported by patients (HS-related pain).
However, it's worth noting that some patients, despite achieving objective results (HiSCR or IHS4-
55), experience minimal reduction in pain. This should prompt us to question whether the
treatment is being truly effective in these patients.