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  • Our study has several limitations First our study included a

    2018-11-12

    Our study has several limitations. First, our study included a small number of patients. Second, because the lesions were only photographed when they were received at biopsy, we are unable to evaluate the treatment outcome of the patients. Furthermore, we do not have any information about long-term follow-up among these patients. There is limited information available on the correlations between dermoscopic and histopathologic patterns of LP. In one recent study, many lesions were dermoscopically analyzed if the patient had numerous lesions; thus, not all lesions were biopsied. Because these studies did not perform biopsy for all lesions, there is a lack of materials that can prove the correlation between histopathologic patterns and dermoscopic patterns. In our study, biopsy was performed for all patients, and all biopsy sites were subject to dermoscopic evaluation.
    Introduction Psoriasis is a chronic inflammatory skin disease and recently Th17 MLN0128 and interleukin (IL)-17 are reported to play major roles in its pathogenesis. With better understanding of the immunological pathways of psoriasis, the treatment of psoriasis has now entered a new era of target therapy. At present, approved biologics for psoriasis include tumor necrosis factor (TNF) blockers and anti-IL-12, anti-IL-23, and anti-IL-17 monoclonal antibodies. Ustekinumab is a human monoclonal antibody that blocks the shared p40 protein of IL-12 and IL-23, subsequently inhibiting the formation of Th1 and Th17 cells. Although ustekinumab shows good efficacy for psoriasis in general, there is still a need for new biologics because (1) 30% of patients still do not meet the 75% reduction in the Psoriasis Area Severity Index (PASI75) score and (2) there is a decrease in drug survival rates with secondary loss of efficacy. In clinical practice, biologic switches are also very commonly used for treating rheumatoid arthritis, ankylosing arthritis, psoriatic arthritis, as well as psoriasis. In the case of TNF blockers, prior treatment with TNF blockers influence the efficacy of second and third TNF blockers. Secukinumab is a newly approved IL-17A monoclonal antibody and the administration regimen is 300-mg subcutaneous injection weekly at Weeks 0, 1, 2, 3, and 4, and then every 4 weeks. Secukinumab not only acts in a new mode of action but also shares some common targets with ustekinumab. In a controlled study (CLEAR), secukinumab has been shown to perform better than ustekinumab. However, in two Phase 3 pivotal studies (ERASURE and FIXTURE), the percentage of patients with prior IL-12/23 use were limited. To date, the efficacy of secukinumab on patients who had ever received ustekinumab previously is unknown. Therefore, we performed this single-center, open-labeled, retrospective study to evaluate the efficacy and safety of secukinumab therapy in nine psoriasis patients who had ever received ustekinumab previously. This is also the first study to evaluate the biologics switch between ustekinumab and secukinumab.
    Methods This is a retrospective study conducted in the dermatology department of a tertiary medical center in Taiwan. Informed consents were obtained from all participants and this trial was approved by the Institutional Review Board of our hospital. We included all nine patients who entered the clinical trial of secukinumab (ERASURE) in our department who had previously received 45-mg ustekinumab monotherapy for at least two injections. The last dose of ustekinumab was at least 2 years before and the washout periods of other systemic therapies and biologics were considered according to the protocol of ERASURE (ustekinumab for 6 months, TNF blockers for 3 months, oral systemic drugs for 4 weeks, psoralen ultraviolet A phototherapy for 4 weeks, ultraviolet B phototherapy for 2 weeks, and topical agents for 2 weeks). Two patients were enrolled into the placebo group (Patient No. 1 and Patient No. 6, and they were shifted to the 150-mg group from Week 12), five patients in the 150-mg group (Patients No. 3, 4, 7, 8, and 9), and two patients in the 300-mg group (Patients No. 2 and 5). Patients in the placebo group were shifted to the experimental group after Week 12, so Week 12 was considered the new baseline for comparing the PASI scores. The PASI scores at Weeks 0, 4, 8, 12, and 16, the absolute PASI score reduction at Week 12, and adverse effects were recorded. A single evaluator was responsible for performing all the assessments.