Background: There is limited long-term, real-world evidence on the efficacy and safety in patients with plaque psoriasis treated with secukinumab. We present results at 136 weeks in a real-world setting with focus on special populations. Research design and methods: Retrospective analysis of 151 patients with chronic plaque psoriasis who initiated treatment with secukinumab between September 2015 and May 2019. Secukinumab 300 mg was administered once weekly for 5 weeks followed by once monthly. Main outcome measures: Clinical and laboratory assessments were performed up to 136 weeks. Results: At 16 weeks, 90%, 79%, and 63% of patients achieved Psoriasis Area and Severity Index (PASI) 75, PASI 90, and PASI 100, respectively, compared with 79%, 72%, and 55% of patients after 136 weeks of therapy with secukinumab. Fifteen of the 151 patients experienced an adverse event, the most common of which was candida infection (4%). Biological treatment naïve was significantly associated with response to therapy at 1 and 2 years (P < 0.0001). There were no safety issues in patients with infection with HBV, HCV or mycobacterium tuberculosis. Conclusions: Our results confirm the rapidity of action of secukinumab as well as its long-lasting efficacy and good safety in real-world clinical practice.
Psoriasis tends to improve for approximately half of patients during pregnancy, but an equal number of patients report no change or worsening during this period, when lots of medications, like biologics, are not indicated. The aim of our study was to review data of patient that had been pregnant during ustekinumab treatment, analyzing data of our data set between September 2010 and February 2018. We found data of three patients that had been pregnant during ustekinumab treatment. All three patients successfully completed the pregnancy without complications. One of the three patients was pregnant even twice during treatment with ustekinumab, with also a successful birth of two perfectly healthy twins. Biologic agents approved for the treatment of moderate-to-severe psoriasis are currently classified as pregnancy category B, even if, particularly for ustekinumab, there are several case reports regarding exposure during pregnancy in humans related to a healthy pregnancy, both for women and children. Although further studies are required to find real indication of biological treatment in pregnant patients, according to our and to the reviewed experience, ustekinumab does not interfere with gestation.
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