CONFERENCE UPDATE: EADV 2024

The impact of secukinumab on mental well-being in patients with moderate to severe HS: Post-hoc analysis of the SUNSHINE/SUNRISE trials

DERMATOLOGY
07 Feb 2025

STUDY DESIGN 

Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition that significantly impacts patients' quality of life (QoL).1 Individuals with HS often experience comorbidities, including psychiatric conditions such as depression and anxiety, with recent findings indicating they are about twice as likely to develop these disorders compared to those without HS.1 Secukinumab has shown sustained efficacy in moderate to severe HS in the SUNSHINE and SUNRISE phase 3 trials, improving QoL while maintaining a favorable safety profile over one year.1

The post-hoc analysis of pooled data from these trials assessed psychiatric comorbidities at baseline and through week 52 in patients treated with secukinumab.1 In both trials, patients were randomized to receive subcutaneous secukinumab 300mg every 2 weeks (SECQ2W) or 4 weeks (SECQ4W), or placebo for 16 weeks.1 After this period, placebo patients switched to secukinumab while those on SECQ2W and SECQ4W continued their treatment until week 52.1 A total of 1,084 patients were enrolled, with a mean age of 36.2 years and 56.3% being female.1

The analysis assessed the frequency of psychiatric comorbidities at baseline, focusing on reports of "psychiatric disorder," "depression," and "anxiety," along with the concomitant use of medications for these conditions during the trial.1

The impact of secukinumab on psychiatric symptoms was assessed using 2 patient-reported outcome measures.1 Mood was evaluated through the "anxiety/depression" item of the European QoL 5-Dimension (EQ-5D) questionnaire up to week 52.1 Emotional impact was measured using the HS Symptom and Impact Diary (HSSID), where patients rated the negative impact of HS on their emotions over the past 24 hours on a 0-3 scale.1 Incidence of new or worsening psychiatric adverse events was also reported through week 52.1 All analyses were exploratory with no statistical

"These findings highlight the positive benefits achieved by patients when treated with secukinumab for HS, particularly with respect to mental and emotional well-being, which is likely due to a holistic effect and overall symptom improvement in patients with HS" 

Presented by Professor Jacek Szepietowski Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland

FINDINGS

Psychiatric comorbidity profile:
  • On trial entry, 19.9% of patients had an ongoing psychiatric disorder1
  • The most common comorbidities reported at baseline were depression (9.8%) and anxiety (7.1%)1
  • Across all patients treated with secukinumab, 13.6% used concomitant medication to treat depression or anxiety1
  • Serotonin reuptake inhibitors (7.5%) and benzodiazepine derivatives (4.4%) were the most commonly reported drug classes, with escitalopram (1.7%), citalopram (1.4%), lorazepam (1.4%) and sertraline (1.4%) most frequently prescribed1
  • 14.8% of patients had an ongoing history of depression or anxiety1
EQ-5D outcomes:
  • At week 16, a higher proportion of patients in the secukinumab groups reported being "not anxious or depressed" vs. baseline, while those treated with placebo reported no improvement (SECQ2W: 38.8% [baseline] vs. 53.7% [week 16]; SECQ4W: 46.4% [baseline] vs. 54.7% [week 16]; placebo: 45.2% [baseline] vs. 44.7% [week 16])1
  • These improvements were sustained through week 52, with placebo-switchers also exhibiting improvements, as well as in patients both with or without any ongoing medical history of depression or anxiety1
HSSID outcomes:
  • At week 16, patients treated with secukinumab experienced greater reductions in negative emotions associated with HS compared with the placebo arm (mean change from baseline SECQ2W: -0.2; SECQ4W: -0.2; placebo: -0.1)1
  • These improvements were sustained through week 521
Safety:
  • The incidence of psychiatric adverse events (AEs) through week 52 was low and similarly reported across treatment groups1
  • The most frequently reported psychiatric disorder AEs reported were depression (any SECQ2W [2.3%]; any SECQ4W [1.5%]) and anxiety (any SECQ2W [0.6%]; any SECQ4W [0.8%])1
  • Suicidal ideation and behaviors were infrequent and occurred in patients with pre-existing depression who were being treated for their disease prior to trial entry (2 cases of suicidal ideation, 1 case of suicide attempt)1
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