BackgroundThere is a concern that topical tacrolimus and pimecrolimus, indicated for second-line treatment of atopic dermatitis, may increase the risk of lymphoma and skin cancer, particularly in children.ObjectiveThe aim of this study was to compare incidence rates (IRs) of lymphoma and skin cancer between new users of topical tacrolimus or pimecrolimus and users of moderate- to high-potency topical corticosteroids (TCSs) and untreated subjects.MethodsThis is a multicenter cohort study with frequency matching by strata of propensity scores in population databases in the Netherlands, Denmark, Sweden, and the UK. IR ratios (IRRs) were estimated using Mantel–Haenszel methods for stratified analysis.ResultsWe included 19,948 children and 66,127 adults initiating tacrolimus, 23,840 children and 37,417 adults initiating pimecrolimus, 584,121 users of TCSs, and 257,074 untreated subjects. IRs of lymphoma per 100,000 person-years were 10.4 events in children and 41.0 events in adults using tacrolimus and 3.0 events in children and 27.0 events in adults using pimecrolimus. The IRR (95% confidence interval [CI]) for lymphoma, tacrolimus versus TCSs, was 3.74 (1.00–14.06) in children and 1.27 (0.94–1.71) in adults. By lymphoma type, the highest IRR was 3.17 (0.58–17.23) for Hodgkin lymphoma in children and 1.76 (95% CI, 0.81–3.79) for cutaneous T-cell lymphoma (CTCL) in adults. For pimecrolimus versus TCSs, the highest IRR was 1.31 (95% CI, 0.33–5.14) for CTCL in adults. Compared with untreated subjects, adults using TCSs had a higher incidence of CTCL (IRR, 10.66; 95% CI, 2.60–43.75). Smaller associations were found between tacrolimus and pimecrolimus use and the risk of malignant melanoma or nonmelanoma skin cancer.ConclusionUse of topical tacrolimus and pimecrolimus was associated with an increased risk of lymphoma. The low IRs imply that even if the increased risk is causal, it represents a small excess risk for individual patients. Residual confounding by severity of atopic dermatitis, increased monitoring of severe patients, and reverse causation could have affected the results.
BackgroundDespite the concerns about a potential increased risk of skin cancer and lymphoma with the use of topical tacrolimus and pimecrolimus, no population-based studies have given an overview of the use of these drugs in Europe.ObjectiveTo assess the use of topical tacrolimus and pimecrolimus in children and adults in Europe.MethodsMulticentre database cohort study comprising data from the Netherlands, Denmark, Sweden and the UK. We analysed users of topical tacrolimus and pimecrolimus starting from the date of first availability (between 2002 and 2003) or start establishment of the prescription database in Sweden (2006) through 2011. Use was assessed separately for children (≤ 18 years) and adults.Results32,052 children and 104,902 adults were treated with topical tacrolimus, and 32,125 children and 58,280 adults were treated with topical pimecrolimus. The number of users increased rapidly after first availability, especially for topical tacrolimus. Topical tacrolimus was more frequently used in all countries except Denmark. For both drugs, there was a decrease in users after 2004 in the Netherlands and Denmark and after 2005 in the UK, especially among children. This decrease was largest in Denmark. The decrease in the number of users was temporary for topical tacrolimus, while use remained relatively low for topical pimecrolimus.ConclusionsThe number of topical tacrolimus and pimecrolimus users increased rapidly after regulatory approval. A transient reduction in topical tacrolimus use and a persistent reduction in topical pimecrolimus use was seen after 2004 in the Netherlands and Denmark and after 2005 in the UK.
Objectives: The British Association of Dermatologists Biologic Interventions Register (BADBIR) is a long-term pharmacovigilance register of patients with psoriasis treated with biologic therapies. The objectives were to describe patterns of use of index biologics for biologic-naïve psoriasis patients in BADBIR by: (i) country; and (ii) comorbid psoriatic arthritis (PsA). MethOds: 7495 patients receiving biologics were recruited from 153 dermatology centres across the United Kingdom and the Republic of Ireland (ROI). Registrations from 01/09/2007 (cohort inception) to 01/01/2016 were included. Patients receiving their first biologic therapy (infliximab, etanercept, adalimumab or ustekinumab) were classified as "biologic-naïve" at registration. Proportions of registrations to each therapy by country and PsA were examined. Results: 6140 biologic-naïve patients (82%) registered to BADBIR (median age 45 years, inter-quartile range 36-54; 60% male). Adalimumab (57%) was the most common index biologic (23% etanercept; 18% ustekinumab; 2% infliximab). 76% registrations were in England (9% Scotland; 5% Northern Ireland (NI); 5% ROI; 5% Wales). Adalimumab registrations were highest (73%) in NI (56% England; 48% ROI; 69% Scotland; 46% Wales); etanercept accounted for 46% registrations in ROI (22% England; 15% NI; 21% Scotland; 34% Wales); ustekinumab registrations were highest (20%) in England (11% NI; 6% ROI; 9% Scotland; 18% Wales). PsA was recorded as a comorbidity in 18% of patients at registration. For patients with concomitant PsA, 62% were commenced on adalimumab (25% etanercept; 10% ustekinumab). From 2009 to 2015, registrations for patients with concomitant PsA to ustekinumab and adalimumab increased (4% to 30% and 51% to 61%, respectively), while etanercept registrations decreased (42% to 9%). cOnclusiOns: Adalimumab was the most commonly prescribed index biologic drug across the United Kingdom and ROI. The availability of biologics has influenced prescribing practices. Future work will explore the influence of guidelines for biologic use on prescribing patterns.
Las dermatosis perforantes son un grupo de enfermedades pápulo-nodulares poco frecuentes, caracterizadas por formación de tapones queratósicos en los cuales los componentes de la matriz dérmica migran hacia la epidermis para ser eliminados sin un factor desencadenante. Se clasifican en primarias y secundarias. Se asocian a enfermedades sistémicas crónicas, y alteraciones de las fibras de colágeno y las elásticas, entre otros.Se presenta un caso de foliculitis perforante, como una dermatosis perforante primaria, para su diagnóstico y tratamiento.
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