STUDY DESIGN

Generalized pustular psoriasis (GPP) is a rare, potentially life-threatening autoinflammatory skin disease characterized by recurrent flares of sterile pustules and systemic inflammation.¹ Spesolimab, a humanized monoclonal antibody targeting the interleukin-36 receptor, is approved as a 900mg intravenous (IV) formulation for the treatment of GPP flares based on results from the pivotal EFFISAYIL-1 study.¹ The ongoing EFFISAYIL-REP study evaluates repeated IV spesolimab treatment in adults with recurrent GPP flares and explores the impact of immunogenicity on efficacy, safety, and pharmacokinetics.¹

EFFISAYIL-REP is an open-label, multicenter, post-marketing study enrolling adults aged >18 years with a documented GPP diagnosis according to European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria, and a high disease burden with frequent flares.¹ Eligible patients on GPP treatment had a history of flares after dose reduction or discontinuation of concomitant GPP medication, or stopped treatment on the day of initial spesolimab administration (no washout period required).¹ Those not on GPP treatment must have had ≥2 flares in the prior year.¹ Concomitant medications could be continued if indicated for conditions other than GPP.¹

The study included a flare-treatment period followed by a 16-week post-flare follow-up, for a total duration of approximately 104-120 weeks per patient.¹ Flare treatment was initiated in patients with GPP flare, defined by a GPP Physician Global Assessment (GPPGA) pustulation subscore ≥2, with new or worsening pustules affecting ≥5% body surface area.¹ Patients received a single 900mg IV dose of spesolimab on day 1 of the initial flare, with an optional second dose on day 8 if flare symptoms persisted or worsened.¹

At the data cut-off, 42 patients were enrolled, with 36 receiving spesolimab for their first flares.¹ The cohort had a slight female preponderance and was predominantly Asian, consistent with known GPP epidemiology.¹ Mean age was 46.2 years, mean body mass index 27.3kg/m², and mean disease duration 8.8 years.¹ Most patients presented with moderate pustulation (GPPGA score 2-3), and 16.7% had severe disease (score 4).¹

The primary endpoint was a GPPGA pustulation subscore of 0 at week 1.¹ The secondary endpoint was a GPPGA pustulation subscore of 0 or 1, with a ≥2-point reduction from baseline at week 1.¹ Safety was monitored throughout the trial.¹

STUDY DESIGN

 

“IV spesolimab demonstrated rapid control of GPP flares during the first treatment episode”

Dr. Choon Siew Eng
Department of Dermatology,
Hospital Sultanah Aminah,
Johor Bahru, Malaysia