A. López-Ferrer

Ustekinumab Treatment of TNF Antagonist-Induced Paradoxical Psoriasis Flare in a Patient with Psoriatic Arthritis: Case Report and Review

Background: Therapy with tumour necrosis factor α (TNF) inhibitors can be associated with paradoxical reactions, namely the de novo development or flaring of conditions that usually respond to these therapeutic agents, such as arthritis, inflammatory bowel disease, sarcoidosis or psoriasis. They are considered a class effect of these drugs, and their incidence ranges from 1 to 5%, with paradoxical psoriasis (psoriasis vulgaris, palmoplantar pustulosis, scalp psoriasis and their combinations) being most frequently reported. Treatment of paradoxical psoriasis often requires withdrawal of the inducing drug and switching to another anti-TNF agent, but often this cannot avoid recurrence or persistence of the rash and/or loss of the therapeutic effect on the underlying condition. Case Report: We report on a 47-year-old woman who developed incapacitating palmoplantar pustulosis and psoriasis vulgaris flare with severe scalp and nail involvement after 5 months of treatment with adalimumab for psoriatic arthritis. Several treatments, including topical corticosteroids, photochemotherapy, ciclosporin, acitretin and etanercept 50 mg twice a day for 1 month, were ineffective or not tolerated. Treatment with ustekinumab 45 mg provided complete resolution of skin lesions with acceptable therapeutic control of the arthritis, with a follow-up duration of 16 months. Conclusion: A review of the reported cases suggests that this may be a therapeutic option in patients who develop paradoxical psoriasis while under treatment for arthritis or Crohn’s disease.

Adalimumab for the treatment of psoriasis in real life: a retrospective cohort of 119 patients at a single Spanish centre.

Patients with moderate‐to‐severe psoriasis treated with adalimumab in daily clinical practice are different from those in clinical trials, and outcomes may differ in different geographical settings.

Long-term study of infliximab for psoriasis in daily practice: drug survival depends on combined treatment, obesity and infusion reactions.

Infiximab has been shown to be highly effective in phase III clinical trials, but limited information is available regarding drug survival and maintenance of efficacy beyond 1 year in real‐life clinical setting.

Secukinumab (AIN457) for the treatment of psoriasis

Psoriasis is a chronic inflammatory disease with a multifactorial origin that appears in patients with genetic predisposition and is induced by environmental factors, and characterized by alterations in the innate and adaptive immunity. IL-17A is one of the specific cytokines involved in the pathogenesis of psoriasis and its inhibition is highly effective in the treatment of patients with moderate and severe psoriasis. Secukinumab is a monoclonal antibody that specifically binds to IL-17A and inhibits the interaction to its receptor, and it has demonstrated its efficacy and safety in the treatment of psoriasis. Phase II and III clinical trials indicate that > 80% of the patients receiving secukinumab achieve Psoriasis Area Severity Index (PASI) 75 at week 12. In the Phase III efficacy of response and safety of two fixed secukinumab regimens in psoriasis trial, PASI 75 rates were 81.6% with 300 mg secukinumab, 71.6% with 150 mg secukinumab and 4.5% with placebo, and responses were maintained up to 52 weeks in the majority of patients. In the Phase III Full Year Investigative Examination Of Secukinumab versus Etanercept Using Two Dosing Regimens To Determine Efficacy in Psoriasis study, the efficacy of secukinumab was compared to etanercept. The results indicate that both doses of secukinumab (150 and 300 mg) showed superior efficacy compared with etanercept throughout the study; PASI 75 rates at week 12 were 77.1% with 300 mg secukinumab, 67% with 150 mg of secukinumab, 44% with etanercept and 4.9% with placebo. PASI 90 and PASI 100 were 54 and 24% with secukinumab 300 mg and 21 and 4% with etanercept at week 12. At week 52, PASI 90 continued to be higher in the secukinumab group (65%) compared with the etanercept group (33%). Regarding safety, the most common side effects were nasopharyngitis and headache. The rate of infections was higher with secukinumab than placebo. This was especially the case for Candida infections, which were more common in the secukinumab group (4.7% with secukinumab 300 mg and 2.3% with secukinumab 150 mg), but all cases were resolved with conventional treatment. Secukinumab is a well-tolerated treatment that has demonstrated efficacy in treating moderate-to-severe plaque psoriasis. Nevertheless, long-term studies are necessary to confirm Phase II and Phase III data.

Crusted (Norwegian) scabies: an under-recognized infestation characterized by an atypical presentation and delayed diagnosis

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Análisis de coste-eficacia incremental de los tratamientos biológicos para la psoriasis en los momentos de valoración significativos para la práctica clínica

The Spanish guidelines for the treatment of psoriasis recommend that drug choice should be guided by the criteria established in the Summary of Product Characteristics (SPC) for each agent and that decisions should be made on a case-by-case basis and take into account economic considerations. Since the introduction of biologic agents, several authors have studied their cost-efficacy. However, none of these studies present an overall view of the results at clinically significant evaluation time points. The equation used for cost-effectiveness analysis, which can support therapeutic decisions, is the incremental cost effectiveness ratio (ICER): ICER = (C1--C2)/(E1--E2), where C1 and E1 are the cost and effect in the treatment group and C2 and E2 are the cost and effect in the control group. The present analysis is intended to provide useful information to guide clinical practice based on the results of a recent meta-analysis, evaluating the most important variables at each time point. The outcomes and time points used were as follows: a 50% reduction in PASI score (PASI 50) at the time point the SPC recommends assessment of response in order to identify primary treatment failure, and PASI 50 and PASI 75 responses at week 24 (the end of the induction phase). The cost of each treatment was calculated on the basis of the pharmaceutical company’s sale price as of January 2014 less the mandatory deduction under Spanish law (Real Decreto 08/2010) plus VAT. In the case of infliximab,

[Psoriatic arthritis: what the dermatologist needs to know, Part 2].

Psoriatic arthritis is defined as inflammatory arthritis occurring in patients with psoriasis and is classified as a seronegative spondyloarthropathy associated with human leukocyte antigen B27. Between 25 and 35% of patients with psoriasis go on to develop psoriatic arthritis during the course of their disease. Given that the skin is affected before the joints in most cases, the dermatologist must be able to recognize the signs and symptoms in order to make a diagnosis and start the most appropriate treatment. This review aims to cover key aspects of the initial diagnostic workup and clinical evaluation. It examines the epidemiology, pathogenesis, and manifestations of psoriatic arthritis, as well as the complementary tests and diagnostic tools the dermatologist should be aware of in order to make the correct diagnosis.

The safety of ustekinumab for the treatment of psoriatic arthritis

ABSTRACT Introduction: The cytokines interleukin (IL)-12 and IL-23 have been involved in the pathogenesis of psoriasis and psoriatic arthritis. Ustekinumab is a fully human monoclonal antibody targeting the p40 subunit shared by IL-12 and IL-23. Ustekinumab prevents the interaction of IL-12 and IL-23 binding to their receptors, blocking the T1 and T17 inflammatory pathways. Ustekinumab has been evaluated for the treatment of various chronic immune mediated diseases including psoriasis and psoriatic arthritis (PsA). Most of the data regarding the safety of ustekinumab come from the experience treating patients with psoriasis, but clinical trials have demonstrated its efficacy and safety in the treatment of both diseases. The most common adverse events observed during the clinical trials are mild in intensity, and include respiratory tract infections, nasopharyngitis, headache and injection site reactions. Throughout long-term ustekinumab treatment, serious infections or major cardiovascular adverse events occurred rarely. Areas covered: In this review we report the safety data that come from phase II and phase III clinical trials that assay the efficacy and safety of ustekinumab in PsA, including recently published data corresponding to long-term studies. Relevant references were obtained through a literature search in MEDLINE/Pubmed (search strategy: ustekinumab AND psoriatic arthritis) for articles published until November 2016, complemented by a manual search. Expert opinion: In clinical practice, ustekinumab is generally a well-tolerated treatment, and the safety profile in psoriatic arthritis is similar to that reported in plaque psoriasis.

Secukinumab is the most efficient treatment for achieving clear skin in psoriatic patients: a cost-consequence study from the Spanish National Health Service

Abstract Objective: To compare the cost consequence of biologic drugs for moderate-to-severe psoriasis from the perspective of the Spanish National Health System. Methods: We built a decision tree with a two-year time horizon. Efficacy data for biologics (etanercept, infliximab, adalimumab, ustekinumab and secukinumab) were drawn from published meta-analyses: PASI75 for the induction phase and PASI90 for the rest of follow-up. Patients with PASI < 75 at week 10–16 were switched to another biologic agent. Efficacy at week 24 was considered the highest possible efficacy for each drug and assumed to remain constant throughout the two-year period. Only drug treatment costs were used. The number needed to treat (NNT), annual cost per patient, annual cost per patient with PASI90 (cost per responder) and cost of primary failure (PASI < 75 at first efficacy evaluation) were calculated. Results: Secukinumab monotherapy was associated with the lowest cost per responder, followed by infliximab and ustekinumab. Treatment sequences starting with secukinumab were the most efficient, having the lowest NNT and cost per responder. Although the annual cost per treatment is similar for all drugs, there are huge differences in the cost per responder. Conclusions: Secukinumab as first-line biologic treatment is the most efficient treatment for moderate-to-severe plaque psoriasis in the short-to-medium term.

Initial results of ixekizumab efficacy and safety in real-world plaque psoriasis patients: A multicenter retrospective study

Ixekizumab (anti‐IL17A) is effective as treatment for moderate‐to‐severe plaque psoriasis, but real‐life data on effectiveness and safety are currently very limited.