Safety of biologic therapy in combination with methotrexate in moderate to severe psoriasis: a cohort study from the BIOBADADERM registry.

BACKGROUND: Safety is an important consideration in decisions on treatment for patients with moderate-to-severe psoriasis and the study of drug safety is the main purpose of the BIOBADADERM registry. The combination of a biologic agent and a conventional systemic drug [generally methotrexate (MTX)] is a common treatment in clinical practice. However, there is a paucity of evidence from real-world practice on the safety of such combination regimens in the treatment of psoriasis. OBJECTIVES: The primary objective of this study was to ascertain whether the use of regimens combining biologic drugs with MTX in the management of moderate-to-severe psoriasis increases the risk of adverse events (AEs) or serious AEs (SAEs). We compared monotherapy using tumour necrosis factor (TNF), interleukin (IL)-17 and IL-23 inhibitors with the use of the same drugs in combination with MTX. METHODS: Using data from the BIOBADADERM registry, we compared biologic monotherapies with therapies that were combined with MTX. We estimated adjusted incidence rate ratios (aIRR) using a random effects Poisson regression with 95% confidence intervals for all AEs, SAEs, infections and serious infections and other AEs by system organ class. RESULTS: We analysed data from 2829 patients and 5441 treatment cycles, a total of 12 853 patient-years. The combination of a biologic with MTX was not associated with statistically significant increases in overall risk of AEs or SAEs in any treatment group. No increase in the total number of infections or serious infections in patients receiving combined therapy was observed for any group. However, treatment with a TNF inhibitor combined with MTX was associated with an increase in the incidence of gastrointestinal AEs (aIRR 2.50, 95% CI 1.57-3.98; P < 0.002). CONCLUSIONS: The risk of AEs and SAEs was not significantly increased in patients with moderate-to-severe psoriasis receiving different classes of biologic drugs combined with MTX compared with those on biologic monotherapy.

Drug Survival in Cyclosporine Treatment for Moderate to Severe Atopic Dermatitis: Analysis of the Spanish Atopic Dermatitis Registry (BIOBADATOP). / Supervivencia de la ciclosporina en el tratamiento de la dermatitis atópica moderada-grave: Registro Español de Dermatitis Atópica (BIOBADATOP).

BACKGROUND: The past 5 years have seen a proliferation of new treatments for atopic dermatitis (AD). We analyzed recent drug survival data for cyclosporine in this setting. Because the Spanish National Healthcare system requires patients with AD to be treated with cyclosporine before they can be prescribed other systemic treatments, drug survival for cyclosporine may be shorter than in other diseases. MATERIAL AND METHOD: Multicenter, observational, prospective cohort study using data from the Spanish Atopic Dermatitis Registry (BIOBADATOP). Data from the Spanish Registry of Systemic Treatments in Psoriasis (BIOBADADERM) were used to create a comparison cohort. RESULTS: We analyzed data for 130 patients with AD treated with cyclosporine (median drug survival, 1 year). Median cyclosporine survival in the psoriasis comparison group (150 patients) was 0.37 years. Drug survival was significantly longer in AD than in psoriasis (P<.001). CONCLUSION: Drug survival of cyclosporine in the BIOBADATOP registry is similar to that described in other series of patients with AD and longer than that observed in the BIOBADADERM psoriasis registry.

Trends of asthma mortality in Galicia from 1993 to 2007.

INTRODUCTION: In the past few years, deaths due to asthma appear to decrease at least in Western countries; but there are significant variations between populations. The aim of this study is to describe the trends in deaths due to asthma between 1993 and 2007 in our community and to analyze any factors associated with this. METHODS: All cases, which had asthma as a cause of death, were included in the study. The mortality data were obtained from the official death certificate from the Deaths Register. Mortality relative risk, based on the calendar year, sociodemographic variables (age and gender), seasons, and days of the week, were estimated using a Poisson generalized linear model with a log-link. RESULTS: In the 15 years of the study period, a total of 1180 people had died due to asthma, mainly in winter (34.5%), women (64.5%), and advanced age (65 years or above; 84.6%). A tendency of decreased mortality in all age groups was observed during the period of the study, which was significant in both the sexes in the 35- to 64-year-old age group, and in males above 65 years. CONCLUSION: Death due to asthma is changing favorably in our community, with a tendency to decrease in the past few years. Advanced age, being female, and the winter period are associated with a higher mortality rate due to asthma.

Diagnostic yield of brush cytology for biliary stenosis during ERCP.

AIM: To evaluate the diagnostic yield of brush cytology for biliary strictures detected on ERCP when a systematic approach is used. PATIENTS AND METHODS: Data on 62 consecutive patients with a biliary stricture on ERCP were collected. Cytological samples were processed immediately after brushing in the endoscopy room, and all were analyzed by the same pathologist. For the statistical analysis specimens were classified as positive, negative, suspicious for malignancy (presence of atypias), and unsatisfactory for evaluation. Final diagnosis was based on either histopathologic (surgery or biopsies by other techniques) or clinical/radiographic diagnosis. RESULTS: A total of 71 cytological specimens were included. Definite diagnosis was malignancy in 49 samples, and benign stricture in 22. Three samples were excluded because of insufficient material or processing artifacts. The sensitivity of biliary brushing was 62% (95% CI 0.47-0.77), specificity was 100%, positive predictive value was 100%, and negative predictive value was 58% (95% CI 0.43-0.75). When suspicious samples were included as malignant, sensitivity was 67% (95% CI 0.54-0.81) without changes in the remaining parameters. Eight patients underwent more than one ERCP. Repeated brush cytology exams in these patients yielded a definitive diagnosis in every case. CONCLUSIONS: Brush cytology has intermediate sensitivity with a high specificity. A systematic approach with a dedicated pathologist and the inclusion of significant atypias as malignant results improves sensitivity. Due to its simplicity brush cytology should be performed in all cases of biliary strictures detected on ERCP, and in case of repeated ERCPs additional cytology brushings are recommended.

Plantar Reconstruction Using a Dermal Substitute: Description of 2 Cases.

Acral lentiginous melanoma is the most common subtype among melanomas on the foot. Reconstruction of a wide surgical defect once it is excised may result in a challenge that requires replacing the lost tissue with another tissue having similarly unique physical characteristics. Although reconstructive options such as skin grafts and either local or distant flaps offer adequate coverage, they often are subject of contraction, muscle atrophy, and contour abnormalities. Dermal substitutes provide support and structure and recreates the dermal layer to ensure a durable reconstruction. We report 2 cases of plantar melanoma in which adequate reconstruction was achieved using a dermal substitute.

[Kikuchi-Fujimoto disease: report of two cases]. / Enfermedad de Kikuchi-Fujimoto: descripción de dos casos.

Kikuchi-Fujimoto disease, described for the first time in 1972, is an unusual diagnosis that is characterized by lymph node enlargement and fever. Cervical lymph nodes are affected so often that ENT specialists should be aware of this entity during differential diagnosis. The diagnosis was done by histological features, necrotizing lymphadenitis. The disease is self-limited and it has good prognosis. We have reviewed two cases in our hospital. We report an aseptic meningoencephalitis as a rare complication.

[Ménétrier disease. Clinical and histological study of 3 cases]. / Enfermedad de Ménétrier. Estudio clínico e histológico de tres casos.

Three cases of Ménétrier's disease diagnosed and treated in our hospital during the last 15 years are presented. We describe the clinical manifestations as well as the pathological findings; one of the cases was complicated by carcinomatous degeneration. On the basis of our experience, we briefly review the controversial clinical, diagnostic and therapeutic aspects of this rare condition.

[Mucinous carcinoma of the prostate: critical review of Elbadawi's criteria]. / Carcinoma mucinoso de la próstata: revisión crítica de los criterios de Elbadawi.

OBJECTIVES: We present our experience on prostatic mucinous adenocarcinoma and at once we practice an actualization and a critical review of Elbadawi's criteria. METHODS: After reviewing 206 prostatic carcinomas diagnosed in our hospital, we describe one case that fulfill criteria for being considered a prostatic mucinous adenocarcinoma. We also carry out a wide literature review trying to define anew the including criteria of this tumour by the light of modern knowledge and technology. CONCLUSIONS: We think that for accepting a tumour as a prostatic mucinous adenocarcinoma, this have to fulfill the following criteria: 1. "More than 25% of a significative tumoral sample is mucinous pattern and present, single or clustered, tumour cells floating in immunohistochemically probed, acidic and neutral, mucin lakes". 2. "Tumour is Gleason 3-4 cribiform pattern with direct transition to colloid areas and usually coexist with classic adenocarcinoma but papillary growth patterns should be excluded. Tumour may contain a moderate proportion of signet-ring cells". 3. "Immunohistochemical staining for PSA have to be strongly positive in both, cribiform and mucinous, areas". 4. "Those PSA nonreactive, or only focally positive, mucinous adenocarcinomas, could be labeled as prostatic only when local or distant mucinous carcinomas are ruled out".

[Kaposi's sarcoma: a sexually transmitted cancer?]. / Sarcoma de Kaposi: un cáncer de transmisión sexual?

Kaposi's sarcoma is a lymphoproliferative opportunistic tumor associated with acquired immunodeficiency syndrome whose frequency is going down due to the use of combined therapies including proteases and others antivirals. During the last years, it has been postulated that it's origin is in the oncogenic potential of HVH-8; however, for the development of the disease, it's necessary the presence of some coadjuvant factors including immunodeficiency and probably a propicious hormonal status. We practiced a bibliographic review of some recent works related with it's etiology and coadyuvant factors implicated in the development of this neoplasia, phrasing some questions that should be answered in the light of future investigative works.

Port site metastases after laparoscopic cholecystectomy for an unexpected gallbladder carcinoma.

Laparoscopic cholecystectomy is a proven, well-accepted surgical technique for removing the diseased gallbladder and has rapidly become the surgical procedure of choice over conventional open cholecystectomy. Radiologists must be aware of the possibility of inadvertent dissemination of incidental gallbladder cancer during laparoscopic cholecystectomy. We report a case of this unusual complication: a patient with port site metastases after laparoscopic cholecystectomy for an unexpected gallbladder carcinoma at an early stage.