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SummaryBackground Long-term safety evaluations of biologics are needed to inform patient management decisions. Objectives To evaluate the safety of ustekinumab in patients with moderate-tosevere psoriasis treated for up to 5 years. Methods Safety data were pooled from four studies of ustekinumab for psoriasis. Rates of adverse events (AEs), serious AEs (SAEs) and AEs of interest [infections, nonmelanoma skin cancers (NMSCs), other malignancies and major adverse cardiovascular events (MACE)] per 100 patient-years (PY) of follow-up were analysed by ustekinumab dose (45 or 90 mg) and by year of follow-up (years 1-5) to evaluate the dose response and impact of cumulative exposure. Observed rates of overall mortality and other malignancies were compared with those expected in the general U.S. population. Results Analyses included 3117 patients (8998 PY) who received one or more doses of ustekinumab, with 1482 patients treated for ‡ 4 years (including 838 patients ‡ 5 years). At year 5, event rates (45 mg, 90 mg, respectively) for overall AEs (242AE6, 225AE3), SAEs (7AE0, 7AE2), serious infections (0AE98, 1AE19), NMSCs (0AE64, 0AE44), other malignancies (0AE59, 0AE61) and MACE (0AE56, 0AE36) were comparable between dose groups. Year-to-year variability was observed, but no increasing trend was evident. Rates of overall mortality and other malignancies were comparable with those expected in the general U.S. population. Conclusions No dose-related or cumulative toxicity was observed with increasing duration of ustekinumab exposure for up to 5 years. Rates of AEs reported in ustekinumab psoriasis trials are generally comparable with those reported for other biologics approved for the treatment of moderate-to-severe psoriasis.

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ADA + C/B resulted in more rapid and higher efficacy within the first 4 weeks; thereafter, the trend was towards a higher response with ADA monotherapy. There was no statistical difference in the PASI 75 response at week 16. Both treatment regimens were well tolerated.

Ustekinumab significantly improves nail psoriasis, and improvements continue over time until up to 1 year of treatment in those receiving maintenance treatment.

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Background Hidradenitis suppurativa (HS), a chronic, recurrent, debilitating skin disease, is characterized by painful, inflammatory, subcutaneous lesions of the axilla, inguinal and anogenital regions. Overall prevalence of HS is ˜1%, and the impact of disease on patient quality of life (QoL) and healthcare resource utilization (HRU) is high.Objectives To estimate the real-world effectiveness of adalimumab (Humiraâ) treatment in patients with moderate-tosevere HS on disease severity, pain, QoL, work productivity and HRU.Methods HARMONY (Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patientsa Multi-cOuNtry studY in Real Life Setting) is a multicentre, postmarketing observational study in adult patients with moderate-to-severe HS. Disease severity and QoL parameters were evaluated using validated measures at 12-week intervals over 52 weeks of treatment. The primary endpoint was the proportion of patients achieving a Hidradenitis Suppurativa Clinical Response (HiSCR: ≥50% reduction in abscess and inflammatory nodule count, with no increase in abscess and draining fistula counts relative to baseline) at 12 weeks. Secondary endpoints were HiSCR at 24, 36 and 52 weeks and changes in QoL parameters and work productivity assessments. Analyses were conducted using asobserved data. ResultsThe proportion of patients reaching the primary HiSCR endpoint was 70.2% (n = 132/188 enrolled) and remained ≥70% until study completion. There were statistically significant (P < 0.0001) reductions in worst and average skin pain. All of the QoL measures evaluated improved significantly (P < 0.0001) by 12 weeks of adalimumab treatment, as did work productivity assessments (P < 0.05), and there was a ˜50% decrease in HRU between baseline and week 52. Adalimumab was well tolerated.Conclusions In this real-world setting, adalimumab treatment of moderate-to-severe HS resulted in decreased disease severity and improvements in QoL and productivity. Response to adalimumab was rapid (within 12 weeks) and sustained (52 weeks). No unexpected safety signals were reported.

Background Impressive progress in new therapeutic options has been made for psoriasis. Treatments include topical steroids, phototherapy, conventional, synthetic disease-modifying drugs and an expanding list of biologics. Objective The primary objective of this work was to collect evidence for the creation of practice guidelines for systemic treatment of psoriasis (BETA-PSO: Belgian Evidence-based Treatment Advice in Psoriasis). Methods Evidence-based recommendations were formulated using a quasi-Delphi methodology after a systematic search of the literature and a consensus procedure involving 8 psoriasis experts. Results In this part, the use of systemic treatment in different age groups, during pregnancy, in metabolic syndrome, in patients with mental health problems, in different psoriasis subtypes and in previously systemically treated patients treatment is discussed. Conclusion Guidance on therapeutic choice in specific clinical situations in psoriasis is provided in order to facilitate the decision-making in clinical practice.