Poster Shows Secukinumab Improves HS Symptoms and Psychiatric Comorbidities

HS/DermNet

Researchers reported positive outcomes in a post hoc analysis of SUNSHINE (NCT03713619) and SUNRISE (NCT03713632) phase 3 trials of secukinumab in patients with moderate to severe hidradenitis suppurativa (HS), according to a poster presented at the Society for Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference in Las Vegas, Nevada.^1-3

The analysis looked at pooled data from 1084 patients who had been randomized to receive placebo (N=363) or secukinumab 300 mg every 2 (N=361) or 4 weeks (N=360) for the first 16 weeks of the trial. At week 16 through week 52, individuals receiving placebo were randomly assigned to receive to the active treatment groups; those who began in the active treatment groups remained in the same group. About half of the patients (56.3%) of the participants were female and mean age was 36.2 years. All participants had moderate to severe HS before enrolling in the SUNSHINE and SUNRISE. Original analysis of the studies indicated the drug resulted in sustained efficacy, improvements in quality of life factors, and favorable safety profile for the study duration.¹

Psychiatric comorbidity was not an exclusion factor for the study. Upon trial initiation, participants were asked to report medical and psychiatric comorbidities. The most commonly reported comorbidities were depression and anxiety. Interestingly, the study authors noted the prevalence in the study group was reported higher than what is expected in the general population (9.8% vs 3/8% for depression and 7.1% vs 4% for anxiety). Almost 14% of patients were also receiving an antidepressant or anxiety medication, with 7.5% receiving any serotonin reuptake inhibitors and 4.4% receiving a benzodiazepine derivative. More specifically, escitalopram (1.7%), citalopram (1.4%), lorazepam (1.4%), and sertraline (1.4%) were the most common.

The European QoL 5-Dimension (EQ-5D) questionnaire was used to measure mood and anxiety symptoms through the duration of the trial. At 16 weeks, more patients who received secukinumab showed improvement over baseline in reporting “not depressed or anxious” versus those in the placebo group. Moreover, the improvement appeared sustained at the 52-week mark, and those who switched to medication from placebo likewise showed improvement.

The investigators wanted to better understand how HS impacted patients’ emotions and psychiatric well-being as well as any impact secukinumab might have. To do so, they leveraged the HS Symptom and Impact Diary (HSSID), which assessed how negatively their emotions were impacted during the past 24 hours using an HS symptom and impact diary. The tool asked participants to rate the impact as 0 if not at all, 1 if a little bit, 2 if moderately; 3 if it was a great deal. The treatment groups scored about the same, regardless if they had an ongoing medical history for depression or anxiety. The investigators reported that patients in the active treatment groups had the biggest improvement, with sustained improvement through week 52.

The investigators also looked at psychiatric adverse effects throughout the study. Overall, the incidence was relatively low across the treatment groups. Of the more serious adverse effects, they found 2 cases of suicidal ideation and 1 suicide attempt, all of which in patients with preexisting depression and under treatment prior to study initiation. Depression (not major depression) was the most commonly reported event, followed by insomnia and anxiety.

“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,” the authors concluded.¹

References

1. Szepietowski JC, Vilarrasa E, Porter M. The impact of secukinumab on psychiatric comorbidities in patients with moderate to severe hidradenitis suppurativa: A post hoc analysis of the pooled data from SUNSHINE and SUNRISE phase 3 trials. Poster presented at the Society for Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference; Las Vegas, Nevada; November 13 – 17, 2024.

2. This Was a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). (SUNSHINE). Accessed November 15, 2024. https://clinicaltrials.gov/study/NCT03713619

3. Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE). Accessed November 15, 2024. https://clinicaltrials.gov/study/NCT03713632