In real-world clinical practice, fewer patients with plaque psoriasis maintain efficacious outcomes at 52 weeks compared with patients enrolled in randomized clinical trials (RCTs), with the majority discontinuing secukinumab therapy at 40 weeks due to lack of efficacy, according to results of a recent multicenter retrospective chart review published in the Journal of the American Academy of Dermatology.1
The study investigators sought to assess the efficacy and safety of secukinumab beyond 12 weeks and to determine whether real-world patients with plaque psoriasis experience similar long-term outcomes as those participating in RCTs. A total of 41 patients age ≥18 with moderate to severe plaque psoriasis and Psoriasis Area and Severity Index (PASI) ≥10 at initiation of secukinumab 300 mg were included in the review.
The efficacy end point was the percentage of participants who achieved a ≥75% reduction in PASI from baseline (PASI 75) or the Physician Global Assessment (PGA) of 0 (clear) or 1 (almost clear) when PASI was not recorded. Safety outcomes were based on adverse events (AEs) reported. All end points were assessed by staff dermatologists at 2 academic dermatology clinics in Toronto, Canada, at weeks 12 and 52, or at the time of treatment discontinuation.
All of the 41 patients evaluated achieved PASI 75 or PGA 0/1 at week 12 and were followed up to week 52 or until secukinumab discontinuation. At week 52, 68.3% of patients (28 of 41) maintained PASI 75 or PGA 0/1, 4.9% (2 of 41) of participants experienced loss of efficacy (<PASI 75), and 26.8% (11 of 41) discontinued treatment before week 52 because of lack of efficacy (n=10) or intolerance (n=1). In the 11 participants who stopped treatment after week 12 and prior to week 52, the mean treatment duration was 40.0 weeks (range, 26.1 to 51.0 weeks).
The findings of the study demonstrate that fewer secukinumab-treated patients maintain PASI 75 response at week 52 (68.3% in the current study) than described in certain RCTs (FIXTURE: 84.3%; ERASURE: 80.5%; and SCULPTURE: 78.2%).2,3
Similar to findings from RCTs, the occurrence of AEs following 12 weeks of secukinumab therapy was reported in 17.1% (7 of 41 patients). The most frequently reported AEs were diarrhea (n=2) and respiratory tract infection (n=2). Discontinuation due to AEs was rare, with only 1 individual stopping treatment between weeks 12 and 52 due to nasopharyngitis that lasted for several weeks.
The investigators concluded that fewer patients with psoriasis in real-world clinical practice maintain efficacy outcomes at week 52 than patients enrolled in RCTs. This may be partly due to patient dissatisfaction following minor relapse of disease.
- Georgakopoulos JR, Ighani A, Phung M, Yeung J. Drug survival of secukinumab in real-world plaque psoriasis patients: a 52-week, multicenter, retrospective study [published online November 24, 2017]. J Am Acad Dermatol. doi:10.1016/j.jaad.2017.11.036
- Mrowietz U, Leonardi CL, Girolomoni G, et al; SCULPTURE Study Group. Secukinumab retreatment-as-needed versus fixed-interval maintenance regimen for moderate to severe plaque psoriasis: A randomized, double-blind, noninferiority trial (SCULPTURE). J Am Acad Dermatol. 2015;73(1):27-36.
- Langley RG, Elewski BE, Lebwohl M, et al; ERASURE Study Group; FIXTURE Study Group. Secukinumab in plaque psoriasis–results of two phase 3 trials. N Engl J Med. 2014;371(4):326-338.