By SPC New Staff

Secukinumab (Cosentyx, Novartis) demonstrated rapid and sustained relief from the common clinical signs and symptoms of moderate to severe hidradenitis suppurativa (HS) with a favorable safety profile, according to data presented at the 2022 European Academy of Dermatology and Venereology (EADV) Congress (abstract LB-3549).

The trials assessed two secukinumab dose regimens across 16-week (vs. placebo) and 52-week treatment periods. Results showed a significantly higher proportion of patients achieved an HS clinical response (HiSCR) when treated with 300 mg of secukinumab, dosed every two weeks, after standard weekly loading doses, compared with placebo at week 16 in both the SUNSHINE and SUNRISE trials (45.0% vs. 33.7% [P=0.0070] and 42.3% vs. 31.2% [P=0.0149], respectively). 

The SUNSHINE and SUNRISE trials comprise the largest phase 3 program in HS enrolling more than 1,000 patients in 33 countries. SUNSHINE (ClinicalTrials.gov Identifier: NCT03713619) and SUNRISE (ClinicalTrials.gov Identifier: NCT03713632) are identical multinational, phase 3, randomized, double-blind, placebo-controlled, parallel-group studies that evaluated the short- and long-term efficacy, safety, and tolerability of two dosing regimens of secukinumab in adults with moderate to severe HS.

SUNSHINE included 541 patients, and SUNRISE included 543 patients. Patients in each study were randomly selected to one of three experimental arms: 

1. secukinumab 300 mg every two weeks after five weekly loading doses; 
2. secukinumab 300 mg every four weeks after five weekly loading doses; and
3. placebo dose every two weeks after five weekly placebo doses. 
   

The primary end point of both trials assessed achievement of HiSCR after 16 weeks of treatment. Key secondary end points included the percentage change from baseline in abscess and inflammatory nodule count at week 16, proportion of patients experiencing a flare over 16 weeks, and proportion of patients with a numerical rating scale 30 (NRS30; skin pain) response (reported as pooled data from both trials) at week 16.

SUNSHINE looked at these parameters up to 52 weeks.

Secukinumab 300 mg dosed every four weeks (after standard weekly loading doses) was superior to placebo for achieving HiSCR in the SUNRISE study (46.1% vs. 31.2% [P=0.0022]), although it did not meet statistical significance in the SUNSHINE study (41.8% vs. 33.7% [P=0.0418]).

HiSCR is defined as at least a 50% decrease in abscess and inflammatory nodule count with no increase in the number of abscesses and/or draining tunnels. The safety profile was consistent with that of secukinumab in existing indications, and no new safety signals were observed in either dosing group, the company said.

A key secondary end point was skin pain, as measured by the patient’s global assessment of NRS30 skin pain. In data pooled from the two studies, the 300-mg dose of secukinumab given every two weeks proved statistically superior to placebo in reducing skin pain, the most bothersome symptom of HS, according to the EADV report. More details on the primary and secondary end points are available on the Novartis website.

Secukinumab, a fully human biologic that inhibits interleukin-17A, an important cytokine involved in the inflammation of psoriatic arthritis, moderate to severe plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis in adults, was approved in 2015. It also has pediatric indications for plaque psoriasis and juvenile idiopathic arthritis.

HS is a chronic, inflammatory, debilitating skin condition with systemic comorbidities that are characterized by recurrent lumps or nodules under the skin that become inflamed and painful, breaking open to cause abscesses and sores. Once considered a rare condition, it is now thought that as many as one in 100 people are affected by HS. There is no cure; and current HS treatment regimens are limited, often inadequate and can require a surgical approach. 

“Hidradenitis suppurativa can cause intense pain, disability and anxiety, impacting many aspects of daily living. However, there are only limited treatment options available that can make a difference to people living with this debilitating disease,” said Alexa B. Kimball, MD, the lead investigator of the trials, and an investigator at Beth Israel Deaconess Medical Center and a professor of dermatology at Harvard Medical School, in Boston. “These efficacy and safety findings are promising for people living with HS, who are in urgent need of new treatment options.”

Novartis said it plans to submit these data to the FDA for this indication.

—From Novartis press materials