Comparison of Secukinumab Versus Guselkumab in Clearing Psoriatic Plaques Refractory to Ustekinumab
Condition: Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Intervention: Skin biopsies
Intervention description: At Baseline, two 6-mm punch biopsies were taken, one from the identified active plaque (TCS ≥ 6) and one from never-lesional skin. At the End-of-study Visit, one biopsy was taken from the same area of the active plaque sampled at Baseline.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a 16-week, randomized, open-label, parallel-group, active-control study comparing secukinumab 300 mg s.c. versus guselkumab 100 mg s.c. in subjects with plaque psoriasis who had an inadequate response to ustekinumab.
Masking: Single (Outcomes Assessor)
Masking description: Blinded outcome assessor assessed subjects on each visit for target plaque TCS, PASI, IGA, BSA, ppIGA, PSSI, NAPS.
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Plaque psoriasis; Secukinumab; Skin condition; skin disease; itching; psoriasis vulgaris; immune-mediated systemic disease; skin lesions; scaly patches; papules

Summary:

      The aim of this study was to describe the effect of direct IL-17A inhibition with secukinumab
      as compared with the selective inhibition of IL-23 with guselkumab (p19 subunit blocker) in
      controlling inflammation in psoriatic plaques that remain active despite treatment with the
      non-selective IL-23 inhibitor ustekinumab (blocker of p40 subunit, shared by IL-12 and IL
      23).
    

Eligibility criteria:

        Inclusion Criteria:

        Chronic plaque-type psoriasis considered inadequately controlled after treatment with
        ustekinumab according to the following criteria-:

          -  Ustekinumab administered at a dose equal or higher than that on the label for at least
             24 weeks. The last administration must be at least 12 weeks before randomization

          -  absolute PASI score of 1-10 at Screening

          -  Presence of at least 1 refractory skin plaque, defined by a TCS of at least 6 and
             severity score of at least 2 or 3 (moderate) for each individual item, with an area ≥
             10 cm2 at screening.

        Exclusion Criteria:

          -  Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and
             guttate psoriasis) at Screening or Baseline

          -  Drug-induced psoriasis (i.e., new onset or current exacerbation from beta-blockers,
             calcium channel inhibitors or lithium) at Baseline

          -  Previous treatment with more than one TNFα inhibitor or with IL-17A (including
             secukinumab), IL-17R or IL-23 (including guselkumab) inhibitors

          -  Use of other investigational drugs within 4 weeks before enrolment, or within a period
             of 5 half lives of enrollment/initiation of the study treatment, whichever is longer

          -  Ongoing use of prohibited treatments (see Section 6.2.2)

          -  Known immunosuppression (e.g., AIDS) at Screening