Data on the effectiveness and safety of a drug in real‐world clinical practice complement the evidence from clinical trials, which are carried out in a different setting. Little has been published on the effectiveness and safety of guselkumab in the treatment of psoriasis in clinical practice. The ojective of this study was to assess the effectiveness and safety of guselkumab at 24 weeks in patients with moderate to severe plaque psoriasis in routine clinical practice. A retrospective, multicentre study of adult patients with moderate to severe plaque psoriasis treated with guselkumab for at least 24 weeks was carried out in Spain. We studied 343 patients, 249 of whom were followed for 24 weeks. By week 24, the mean (SD) psoriasis area severity index (PASI) had decreased from 11.1 (7.3) to 1.7 (2.8) (−9.3; [−10.2;‐8.4]), 85.9% of the patients had achieved PASI score of 4 or less and 77.9% a PASI score of 2 or less. In terms of relative PASI response, 59.4% of the patients achieved a PASI‐90 response and 49.0% a PASI‐100 response. On multivariate analysis, two factors reduced the probability of a PASI of 2 or less at 24 weeks: a BMI ≥30 (OR, 0.44; 95% CI, 0.22–0.88) and a greater previous exposure to biologic therapy (OR, 0.69; 95% CI, [0.56–0.84]). Adverse events were rare (9.9%) and led to withdrawal from treatment in only nine patients (2.6%) by the end of the follow‐up period. The results of this study confirm the high efficacy and safety of guselkumab indicated by the clinical trial data. In clinical practice, the absolute PASI score appears to be a better marker of response to treatment than the relative value.
Summary Mid-dermal elastolysis is an unusual process characterized by the absence of the elastic fibres within the mid-dermis. The disappearance of these fibres causes fine wrinkles (type 1) or perifollicular protrusions (type 2) affecting the trunk, neck and arms. There is a female predilection, and most patients have a history of intense sun exposure. Recently, some cases of mid-dermal elastolysis presenting as reticular erythema have been reported. We report a case of reticular erythema with mid-dermal elastolysis that occurred in a 70-year-old man after insertion of a pacemaker.
Biosimilar drugs are very similar to the originator products, with no meaningful differences in efficacy and safety. [1][2][3][4] Several biosimilars of infliximab, etanercept, and adalimumab have been approved by the European Medicines Agency (EMA) in Europe for the treatment of immune-mediated diseases. [5][6][7] Previous studies have suggested that drug survival of biosimilars in patients with psoriasis is similar to that of the corresponging originator products. 8,9 On the other hand, patients switching from originator to biosimilar biologics are more likely to discontinue treatment than those who continue on the originator; the hazard ratio is 3.57 (p < 0.001) for infliximab across several indications. 10 The aim of this study was to describe the real-world drug survival of adalimumab biosimilars in patients with moderate to severe psoriasis from 17 large hospitals representative of different regions in Spain, and to identify potential differences associated with patients' characteristics or type of treatment initiation. According to access regulations in Spain, the vast majority of biologic naïve patients are required to start with a biosimilar biologic (usually adalimumab) and switching to biosimilar adalimumab was required for most patients who were receiving adalimumab originator with adequate response; this switching because of pharmacoeconomic considerations will be referred to as nonmedical switching henceforth.This was an observational, retrospective, multicenter study (Clinical Trials.gov NCT04808739). Clinical data were extracted from the patients' records at the Departments of Dermatology of the 17 participating hospitals. Variables included for statistical analysis
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