Cross-Cultural Measurement Invariance in the Personality Inventory for DSM-5✰.

The validity of cross-cultural comparisons of test scores requires that scores have the same meaning across cultures, which is usually tested by checking the invariance of the measurement model across groups. In the last decade, a large number of studies were conducted to verify the equivalence across cultures of the dimensional Alternative Model of Personality Disorders (DSM-5 Section III). These studies have provided information on configural invariance (i.e., the facets that compose the domains are the same) and metric invariance (i.e., facet-domain relationships are equal across groups), but not on the stricter scalar invariance (i.e., the baseline levels of the facets are the same), which is a prerequisite for meaningfully comparing group means. The present study aims to address this gap. The Personality Inventory for DSM-5 (PID-5) was administered to five samples differing on country and language (Belgium, Catalonia, France, Spain, and Switzerland), with a total of 4,380 participants. Configural and metric invariance were supported, denoting that the model structure was stable across samples. Partial scalar invariance was supported, being minimal the influence of non-invariant facets. This allowed cross-cultural mean comparisons. Results are discussed in light of the sample composition and a possible impact of culture on development of psychopathology.

Is there a healthy migrant effect in relation to oral health among adults in England?

OBJECTIVE: The aim of the study was to assess the healthy migrant effect in relation to oral health among adults in England. STUDY DESIGN: This is a secondary data analysis of a nationally representative survey. METHODS: Data from 13,373 adults of Irish, black Caribbean, Indian, Pakistani, Bangladeshi and Chinese ethnicity, who participated in the Health Survey for England, were analysed. The proportions of edentate and dentate adults with toothache in the last 6 months in first- and second-generation migrants within each ethnic group were compared with those in the white British (reference group) ethnic group in logistic regression models after adjusting for demographic factors and socio-economic position. Among first-generation migrants, the associations of age at arrival and length of residence with each oral health outcome were assessed in logistic regression models after adjusting for sociodemographic factors. RESULTS: Compared with white British migrants, first-generation black Caribbean (odds ratio [OR]: 1.42) and second-generation Pakistani (OR: 3.16) migrants had higher odds of being edentulous, whereas first-generation Indian (OR: 0.62), Pakistani (OR: 0.62), Bangladeshi (OR: 0.41) and Chinese (OR: 0.49) migrants had lower odds. Among dentate adults, second-generation Irish (OR: 1.51) migrants, first- and second-generation black Caribbean (OR: 1.61 and 1.54, respectively) migrants, first-generation Indian (OR: 1.24) migrants and second-generation Pakistani (OR: 1.34) migrants had higher odds of having toothache in the past 6 months, whereas second-generation Bangladeshi (OR: 0.51) migrants had lower odds than white British. Age at arrival and length of residence were positively associated with being edentulous among first-generation black Caribbean, Pakistani and Bangladeshi migrants. CONCLUSION: Evidence on the healthy migrant effect was mixed, with more consistent findings seen for edentulousness among Asian groups. Black Caribbean migrants were generally the ethnic group with the worst oral health when compared with white British.

Middle East respiratory syndrome coronavirus experimental transmission using a pig model.

Dromedary camels are the main reservoir of Middle East respiratory syndrome coronavirus (MERS-CoV), but other livestock species (i.e., alpacas, llamas, and pigs) are also susceptible to infection with MERS-CoV. Animal-to-animal transmission in alpacas was reported, but evidence for transmission in other species has not been proved. This study explored pig-to-pig MERS-CoV transmission experimentally. Virus was present in nasal swabs of infected animals, and limited amounts of viral RNA, but no infectious virus were detected in the direct contact pigs. No virus was detected in the indirect contact group. Furthermore, direct and indirect contact pigs did not develop specific antibodies against MERS-CoV. Therefore, the role of pigs as reservoir is probably negligible, although it deserves further confirmation.

Advancing vector biology research: a community survey for future directions, research applications and infrastructure requirements.

Vector-borne pathogens impact public health, animal production, and animal welfare. Research on arthropod vectors such as mosquitoes, ticks, sandflies, and midges which transmit pathogens to humans and economically important animals is crucial for development of new control measures that target transmission by the vector. While insecticides are an important part of this arsenal, appearance of resistance mechanisms is increasingly common. Novel tools for genetic manipulation of vectors, use of Wolbachia endosymbiotic bacteria, and other biological control mechanisms to prevent pathogen transmission have led to promising new intervention strategies, adding to strong interest in vector biology and genetics as well as vector-pathogen interactions. Vector research is therefore at a crucial juncture, and strategic decisions on future research directions and research infrastructure investment should be informed by the research community. A survey initiated by the European Horizon 2020 INFRAVEC-2 consortium set out to canvass priorities in the vector biology research community and to determine key activities that are needed for researchers to efficiently study vectors, vector-pathogen interactions, as well as access the structures and services that allow such activities to be carried out. We summarize the most important findings of the survey which in particular reflect the priorities of researchers in European countries, and which will be of use to stakeholders that include researchers, government, and research organizations.

Dealing with the high cost of biological therapies: developing and implementing a biological therapy prioritization protocol for ankylosing spondylitis patients in a tertiary hospital.

OBJECTIVE: In January 2011, a biological therapies commission was created in our hospital to fully address the management of biological drugs. A biological therapy prioritization protocol was developed for ankylosing spondylitis (AS) patients. Here, we describe it and report on its economic impact to illustrate how we are optimizing the use of these expensive new drugs. METHODS: The biological therapies commission established several procedures for the rational use of biological drugs such as cost-efficiency therapeutic protocols, pharmacovigilance, and therapeutic drug monitoring programs. The AS protocol was based on clinical and economic aspects. We estimated the economic impact of the protocol by comparing the cost of treating AS patients with biological drugs in the pre-commission (2009 - 2010) vs. post-commission period (2011 - 2013). AS patients treated with adalimumab (ADA), etanercept (ETN) or infliximab (IFX) for at least 6 months in the 2009 - 2013 period were included. RESULTS: 107 patients were included. In the pre-commission period, total expenses increased by +30,944 Euro (+4%). After protocol implementation, total expenses decreased by 11,441 Euro (-1%) during 2011, and by an additional 36,781 Euro (-4%) and 53,872 Euro (-8%) in 2012 and 2013, respectively. In the 2010 - 2013 period the cost of biological therapy per patient-year decreased by 869 €, suggesting the positive effects of the biological therapy prioritization protocol instauration. CONCLUSION: We describe the establishment of a multidisciplinary biological therapy commission to optimize the use of biological therapies. We illustrate its work in developing a protocol for the management of AS patients with such therapies. We show that after 3-years of implementation, the biological therapy prioritization protocol allowed us to steadily decrease the direct cost of biological drug therapies per patient, up to 869 Euro.

Effectiveness of infliximab, adalimumab and golimumab for non-infectious refractory uveitis in adults.

AIM: To discuss the available data regarding the off-label uses of anti-TNF agents in non-infectious uveitis. DATA SOURCE: A literature search was performed in Medline through PubMed from January 2001 to January 2014. STUDY SELECTION AND DATA EXTRACTION: English-language articles about uveitis treatment with anti-TNF drugs in adult patients were reviewed. DATA SYNTHESIS: The use of anti-TNF-Î ± drugs for treatment of several refractory manifestations of refractory uveitis in adult patients is increasing. However, due to the lack of evidence from randomized controlled trials, the use of anti-TNF in uveitis remains “off-label” in most countries. There is no trial-based evidence to support it except for the experience provided by cases and case series. This experience, which is continuously increasing, has yielded encouraging results. Anti-TNF-Î ± drugs, such as infliximab, adalimumab, and golimumab, are reasonably effective for controlling ocular inflammation and sparing patients corticosteroid treatment in non-infectious refractory uveitis. Approximately 80% of patients on infliximab, adalimumab, or golimumab were able to achieve sustained control of inflammation by 6 months. CONCLUSION: Anti-TNF-Î ± therapy is effective in inducing clinical remission for refractory uveitis, with a relatively low rate of treatment-ending adverse events. However, randomized and controlled trials are required to adequately assess the maintained clinical efficacy and safety profile in the long term of anti-TNF agents for non-infectious refractory uveitis.

Economical impact associated with a biological therapy prioritization protocol in patients with rheumatoid arthritis in the Hospital of Sagunto.

BACKGROUND: Until 2010 the cost of biological treatments in Rheumatoid Arthritis (RA) was increasing annually by 15% in our hospital. In 1st January 2011, a Hospital Commission of Biological Therapies involving rheumatology and pharmacy services was created to improve the management of biological drugs and a biological therapy prioritization protocol in RA patients was also established to improve the efficient usage of biological drugs in RA. OBJECTIVE: To evaluate the economic impact associated with a biological therapy prioritization protocol for RA patients in the Hospital of Sagunto. METHODS: Observational, ambispective study comparing the associated cost of RA patients treated with biological drugs in the pre-protocol (2009 - 2010) versus post-protocol periods (2011 - 2012). RA patients treated with Abatacept (ABA), Adalimumab (ADA), Etanercept (ETN) or Infliximab (IFX) for at least 6 months during the study period (2009 - 2012) were included. In 2012, Tocilizumab (TCZ) was also included in the prioritization protocol. Prioritization protocol was established based on both clinical and economical aspects and supervised case by case by our Commission. Cost savings and economic impact were calculated using Spanish official prices. RESULTS: In the pre-protocol period (2009 - 2010), total expenses were increasing by €110,000, up to €1,761,000 in 2010 (€11,362 pat/year). After protocol implementation, total expenses decreased by 53,676€ on the 2010 - 2011 period, and 149,200€ on the 2011 - 2012 period. On the 2010 - 2011 period the cost of biological therapy per patient-year decreased 355€ (11,007€ pat/year) and additional 653€ (up to 10,354€ pat/year) by 2012, with a cumulative effect of the protocol implementation of 1,008€ per patient-year. In the pre-protocol period (2009), the annual cost/patient was 10.812€ with ETN, 10.942€ with IFX, 12.961€ with ADA and 12.739€ with ABA. By 1st January 2013, the annual cost per patient was 9,469€ with ETN, 10,579€ with IFX, 11,117€ with ADA, 13,540€ with ABA and 14,932€ with TCZ. CONCLUSIONS: The creation of our Commission of Biological Therapies is key to rational management of RA patients and optimization of resources, allowing us to save 200,000€ after 2-year efficiency protocol implementation.

Efficacy assessment of an MVA vectored Rift Valley Fever vaccine in lambs.

The present study has evaluated the protection conferred by a single subcutaneous dose of a modified vaccinia virus Ankara (MVA) vectored vaccine encoding the Rift Valley Fever virus (RVFV) glycoproteins Gn and Gc in lambs. Three groups of six to seven lambs were immunized as follows: one group received the vaccine (termed rMVA-GnGc), a second group received an MVA vector (vector control) and a third group received saline solution (non-vaccinated control). Fourteen days later, all animals were subcutaneously challenged with 10(5) TCID50 of the virulent RVFV isolate 56/74 and vaccine efficacy assessed using standard endpoints. Two lambs (one from the vaccine group and one from the vector control group) succumbed to RVFV challenge, showing characteristic liver lesions. Lambs from both the vector control and non-vaccinated groups were febrile from days 2 to 5 post challenge (pc) while those in the rMVA-GnGc group showed a single peak of pyrexia at day 3 pc. RVFV RNA was detected in both nasal and oral swabs from days 3 to 7 pc in some lambs from the vector control and non-vaccinated groups, but no viral shedding could be detected in the surviving lambs vaccinated with rMVA-GnGc. Together, the data suggest that a single dose of the rMVA-GnGc vaccine may be sufficient to reduce RVFV shedding and duration of viremia but does not provide sterile immunity nor protection from disease. Further optimization of this vaccine approach in lambs is warranted.

[Predictors of the use of the early invasive strategy in women with non-ST-elevation acute coronary syndrome]. / Predictores del uso de la estrategia invasiva precoz en mujeres con síndrome coronario agudo sin elevación de ST.

OBJECTIVE: To identify determinants associated to an early invasive strategy in women with acute coronary syndromes without ST elevation (NSTE-ACS). DESIGN: A retrospective cohort study was made. Crude and adjusted analysis of the performance of the early invasive strategy using logistic regression. SETTING: Coronary Units enrolled in 2010 - 2011 in the ARIAM-SEMICYUC registry. PATIENTS: A total of 440 women with NSTE-ACS were studied. Sixteen patients were excluded due to insufficient data, together with 58 patients subjected to elective coronary angiography (> 72 h). VARIABLES ANALYZED: Demographic parameters, coronary risk factors, previous medication, comorbidity. Clinical, laboratory, hemodynamic and electrocardiographic data of the episode. RESULTS: Women treated conservatively were of older age, had oral anticoagulation, diabetes, previous coronary lesions, and heart failure (p<0.005), increased baseline bleeding and ischemic risk (p=0.05) and a higher heart rate upon admission (p<0.05). After adjustment, only age > 80 years (OR 0.48, 95% CI 0.27 to 0.82, p=0.009), known coronary lesions (OR 0.47, 95% CI 0.26-0.84, p=0.011), and heart rate (OR 0.98, 95% CI 0.97-0.99, p=0.003) were independently associated to conservative treatment. Smoking (OR 2.50, 95% CI 1.20 to 5.19, p=0.013) and high-risk electrocardiogram (OR 2.96, 95% CI 1.72 to 4.97, p<0.001) were associated to the early invasive strategy. The exclusion of early deaths (<24 h) did not alter these results. CONCLUSIONS: In women with NSTE ACS, smoking and a high-risk electrocardiogram upon admission were independent factors associated to the early invasive strategy. Previous coronary lesions, age > 80 years and increased heart rate were independent factors associated to conservative treatment.

Clinical and economic impact of the use of etanercept 25 mg once weekly in rheumatoid arthritis, psoriatic arthropathy and ankylosing spondylitis patients.

OBJECTIVE: To determine the clinical and economic impact of etanercept 25 mg/week (ETN25) on rheumatoid arthritis (RA), psoriatic arthropathy (PA) and ankylosing spondylitis (AS) patients in sustained clinical remission. METHODS: Observational, retrospective cohort of patients treated with etanercept 50 mg/week (ETN50) who achieved and maintained clinical remission (Disease Activity Score 28 < 2.6 or BASDAI < 2) over a period of 1 year and had slow worsening of structural changes were enrolled in an off-label program (January 2006 to June 2013) to switch from ETN50 to ETN25. Economic impact was assessed using Enbrel® official prices for Spain. RESULTS: From 1 January 2006 to 1 June 2013, 98 RA, 40 PA and 47 AS patients were treated with ETN50; 39 (24%) patients (20 women; age = 53 ± 7 years; 24 RA, 7 PA, 8 AS) received ETN25 for at least 0.5 years (2.6 ± 2.0 years; range = 0.5 - 7.3 years). As of 1 June 2013, 29 (74%) patients continued on ETN25. RA patients: 17 patients continued on ETN25, 5 patients discontinued use due to reactivation of RA (4 switched back to ETN50 and 1 switched to adalimumab; all regained clinical remission) and 2 patients discontinued use due to adverse reactions. PA patients: four patients continued on ETN25, two patients discontinued use due to reactivation of PA (switched back to ETN50, regaining clinical remission) and one patient discontinued use due to adverse reaction. All AS patients continued on ETN25. The total savings associated with ETN25 over the 7-year observation period were €622,073, resulting in the ability to treat 52 additional patients with ETN50 for one year without increasing total ETN costs. CONCLUSION: ETN25 produces cost savings while maintaining clinical response in a high proportion of patients after at least one year under clinical remission with ETN50. At a time when the cost of therapy is an unavoidable component of healthcare treatment decisions, ETN25 could be a cost-effective option for selective RA, PA and AS patients.

Pathobiology and transmission of highly and low pathogenic avian influenza viruses in European quail (Coturnix c. coturnix).

European quail (Coturnix c. coturnix) may share with Japanese quail (Coturnix c. japonica) its potential as an intermediate host and reservoir of avian influenza viruses (AIV). To elucidate this question, European quail were experimentally challenged with two highly pathogenic AIV (HPAIV) (H7N1/HP and H5N1/HP) and one low pathogenic AIV (LPAIV) (H7N2/LP). Contact animals were also used to assess the viral transmission among birds. Severe neurological signs and mortality rates of 67% (H7N1/HP) and 92% (H5N1/HP) were observed. Although histopathological findings were present in both HPAIV-infected groups, H5N1/HP-quail displayed a broader viral antigen distribution and extent of microscopic lesions. Neither clinical nor pathological involvement was observed in LPAIV-infected quail. Consistent long-term viral shedding and effective transmission to naive quail was demonstrated for the three studied AIV. Drinking water arose as a possible transmission route and feathers as a potential origin of HPAIV dissemination. The present study demonstrates that European quail may play a major role in AI epidemiology, highlighting the need to further understand its putative role as an intermediate host for avian/mammalian reassortant viruses.

Goats primed with Mycobacterium bovis BCG and boosted with a recombinant adenovirus expressing Ag85A show enhanced protection against tuberculosis.

This is the first efficacy study using the experimental goat model, a natural host of tuberculosis (TB), to evaluate the efficacy of heterologous Mycobacterium bovis bacillus Calmette-Guérin (BCG) prime followed by boosting with a replication-deficient adenovirus expressing the antigen Ag85A (AdAg85A). Three experimental groups of 11 goat kids each were used: BCG vaccinated, BCG vaccinated and AdAg85A boosted, and nonvaccinated. Twenty-two goat kids were vaccinated with ∼5 × 10(5) CFU of BCG (week 0), and 11 of them were boosted at week 8 with 10(9) PFU of AdAg85A. At week 14, all goats were challenged by the endobronchial route with ∼1.5 × 10(3) CFU of Mycobacterium caprae. The animals were euthanized at week 28. Cellular and humoral immunity induced by vaccination and M. caprae infection was measured throughout the study. After challenge BCG-AdAg85A-vaccinated animals exhibited reduced pathology compared to BCG-vaccinated animals in lungs and in pulmonary lymph nodes. There were significant reductions in bacterial load in both groups of vaccinated goats, but the reduction was more pronounced in prime-boosted animals. Antigen-specific gamma interferon (IFN-γ) and humoral responses were identified as prognostic biomarkers of vaccination outcome depending on their correlation with pathological and bacteriological results. As far as we know, this is the first report using multidetector computed tomography (MDCT) to measure vaccine efficacy against pulmonary TB in an animal model. The use in vaccine trials of animals that are natural hosts of TB may improve research into human TB vaccines.

Lymphoplasmacytic endotheliitis and anterior uveitis in sheep infected experimentally with rift valley fever virus.

Lymphoplasmacytic endotheliitis and anterior uveitis was diagnosed in four lambs infected experimentally with field isolates of Rift Valley fever virus (RVFV). Formalin-fixed and paraffin wax-embedded tissue from these animals was investigated by histopathology and quantitative real time reverse transcriptase polymerase chain reaction. To our knowledge, this is the first pathological description of this ocular manifestation of RVFV infection in ruminants, although these lesions have been described in man.

[Early invasive strategy in non-ST-segment elevation acute coronary syndrome. The paradox continues]. / Uso de la estrategia invasiva precoz en el síndrome coronario agudo sin elevación de ST. La paradoja continúa.

OBJECTIVE: Observational studies have reported a paradoxical inverse relationship between the use of an early invasive strategy (EIS) and the risk of events in patients with non-ST-segment elevation acute coronary syndrome (NSTE ACS). The study objectives are: 1) to examine the association between baseline risk in patients with NSTE ACS and the use of EIS; and 2) to identify some of the factors independently associated to the use of EIS. DESIGN: Retrospective cohort study. SETTING: Intensive care units participating in the SEMICYUC ARIAM Registry. PATIENTS: Consecutive patients admitted with a diagnosis of NSTE-ACS within 48 hours of evolution between the months of April-July 2010. INTERVENTIONS: None. MAIN OUTCOMES: Coronary angiography with or without angioplasty within 72 hours, risk stratification using the GRACE scale. RESULTS: We analyzed 543 patients with NSTE-ACS, of which 194 were of low risk, 170 intermediate risk and 179 high risk. The EIS was used in 62.4% of the patients at low risk, in 60.2% of those with intermediate risk, and in 49.7% of those at high risk (p for tendency 0.0144). The EIS was used preferentially in patients with low severity and comorbidity. In the logistic regression model, EIS was independently associated to the availability of a catheterization laboratory (OR 2.22 [CI 95% 1.55 to 3.19]), the presence of ST changes on ECG (OR 1.80 [1.23 to 2.64]), or the existence of a low risk of bleeding (OR 0.76 [0.66 to 0.88)]. Conversely, EIS was less prevalent in patients with diabetes (OR 0.60 [0.41 to 0.88]) or tachycardia upon admission (OR 0.54 [0 36 to 0.82]). CONCLUSIONS: In 2010 there remained a lesser relative use of EIS in patients at high risk, due in part to an increased risk of bleeding in these patients.

Pathogenesis of highly pathogenic avian influenza A virus (H7N1) infection in chickens inoculated with three different doses.

To study the pathogenesis of a H7N1 highly pathogenic avian influenza virus strain, specific pathogen free chickens were inoculated with decreasing concentrations of virus: 10(5.5) median embryo lethal dose (ELD(50)) (G1), 10(3.5) ELD(50) (G2) and 10(1.5) ELD(50) (G3). Disease progression was monitored over a period of 16 days and sequential necropsies and tissue samples were collected for histological and immunohistochemical examination. Viral RNA loads were also quantified in different tissues, blood, oropharyngeal swabs, and cloacal swabs using quantitative real-time reverse transcriptase-polymerase chain reaction (RT-qPCR). Clinical signs of depression, apathy, listlessness, huddling and ruffled feathers were recorded in G1 and a few G2 birds, whilst neurological signs were only observed in chickens inoculated with the highest dose. Gross lesions of haemorrhages were observed in the unfeathered skin of the comb and legs, and skeletal muscle, lung, pancreas and kidneys of birds inoculated with 10(5.5) ELD(50) and 10(3.5) ELD(50) doses. Microscopic lesions and viral antigen were demonstrated in cells of the nasal cavity, lung, heart, skeletal muscle, brain, spinal cord, gastrointestinal tract, pancreas, liver, bone marrow, thymus, bursa of Fabricius, spleen, kidney, adrenal gland and skin. Viral RNA was detected by RT-qPCR in kidney, lung, intestine, and brain samples of G1 and G2 birds. However, in birds infected with the lowest dose, viral RNA was detected only in brain and lung samples in low amounts at 5 and 7 days post infection. Interestingly, viral shedding was observed in oropharyngeal and cloacal swabs with proportionate decrease with the inoculation dose. We conclude that although an adequate infectious dose is critical in reproducing the clinical infection, chickens exposed to lower doses can be infected and shed virus representing a risk for the dissemination of the viral agent.

Persistence of highly pathogenic avian influenza virus (H7N1) in infected chickens: feather as a suitable sample for diagnosis.

Selection of an ideal sample is a vital element in early detection of influenza infection. Rapid identification of infectious individuals or animals is crucial not only for avian influenza virus (AIV) surveillance programmes, but also for treatment and containment strategies. This study used a combination of quantitative real-time RT-PCR with an internal positive control and a cell-titration system to examine the presence of virus in different samples during active experimental AIV infection and its persistence in the infected carcasses. Oropharyngeal/cloacal swabs as well as feather pulp and blood samples were collected from 15-day-old chicks infected with H7N1 highly pathogenic AIV (HPAIV) and the kinetics of virus shedding during active infection were evaluated. Additionally, several samples (muscle, skin, brain, feather pulp and oropharyngeal and cloacal swabs) were examined to assess the persistence of virus in the HPAIV-infected carcasses. Based on the results, feather pulp was found to be the best sample to detect and isolate HPAIV from infected chicks from 24 h after inoculation onwards. Kinetic studies on the persistence of virus in infected carcasses revealed that tissues such as muscle could potentially transmit infectious virus for 3 days post-mortem (p.m.), whilst other tissues such as skin, feather pulp and brain retained their infectivity for as long as 5-6 days p.m. at environmental temperature (22-23 degrees C). These results strongly favour feather as a useful sample for HPAIV diagnosis in infected chickens as well as in carcasses.

[Quality indicators in the acute coronary syndrome for the analysis of the pre- and in-hospital care process]. / Indicadores de calidad en el síndrome coronario agudo para el análisis del proceso asistencial pre e intrahospitalario.

We present a map of 27 indicators to measure the care quality given to patients with acute coronary syndrome attended in the pre- and hospital area. This includes technical process indicators (registration of care intervals, performance of electrocardiogram, monitoring and vein access, assessment of prognostic risk, hemorrhage and in-hospital mortality, use of reperfusion techniques and performance of echocardiograph), pharmacological process indicators (platelet receptors inhibition, anticoagulation, thrombolysis, beta-blockers, angiotensin converting inhibitors and lipid lowering drugs) and outcomes indicators (quality scales of the care given and mortality).

Acceptability of switching adalimumab from a prefilled syringe to an autoinjection pen.

OBJECTIVE: To assess patients' acceptance of switching adalimumab from a prefilled syringe to an autoinjection pen. METHODS: A two-phase cross-sectional study. The first phase consisted of a 2-h information/education session to present the pen and assist patients in learning its use. At the end of the session, patients completed a self-administered questionnaire regarding usefulness of the meeting. At the next hospital pharmacy dispensing visit the autoinjection pen was provided. Four single-use prefilled devices (40 mg/0.8 ml every other week) were provided. RESULTS: The study population included 55 patients (rheumatoid arthritis 29, psoriatic arthritis 17, ankylosing spondylitis 9). Attendees showed a high degree of satisfaction with the education session (between 72.7 and 90.9% rated the relevant items of the questionnaire in the highest category). Fifty-one patients participated in the second phase of the study. Patients reported 100% adherence to treatment with the autoinjection pen. The percentage of patients self-administering medication increased from 51 to 84% and the percentage attending primary care for injection decreased from 33 to 2%. Pain at the injection site was significantly reduced with the use of the autoinjection pen. The mean (sd) visual analogue scale (VAS) score was 3.52 (2.26) for the syringe compared with 2.02 (2.16) for the pen (p < 0.001). Forty-four (86.3%) patients considered that the use of the autoinjection pen was easier than the syringe, and 96.1% chose the pen as their preferred delivery system. CONCLUSIONS: This study provides further evidence to support the use of the autoinjection pen as a delivery option for adalimumab therapy.

Urticaria due to etanercept in a patient with psoriatic arthritis.

A 50-year-old woman was referred to our emergency room because of urticaria. Eleven days after etanercept therapy was started, the patient developed an urticarial rash of the trunk and face. A diagnosis of generalized urticaria was made. Etanercept treatment was suspended. Treatment was started with methylprednisolone and dexchlorpheniramine. The patient's condition improved and she was discharged. In this case, the most probable cause of urticaria was considered to be etanercept because of the temporal relationship between exposure to the drug and the onset of symptoms. The adverse reaction could be considered probable. Although the overall risk of skin adverse events associated with etanercept appears low, clinicians should be aware of this reaction.

Septic shock and community-acquired pneumonia associated with etanercept therapy.

OBJECTIVE: To report a case of septic shock and community-acquired pneumonia in a patient with psoriatic arthritis receiving treatment with etanercept. PATIENT DETAILS: A 65-year-old woman diagnosed as having psoriatic arthritis had received treatment with etanercept. Chest X-ray studies were normal and the tuberculin skin test was negative. Two months after etanercept therapy, the patient presented to our emergency department with fever, cough, chest pain and generalized weakness. Chest radiography revealed a right pulmonary infiltrate. Her condition rapidly deteriorated and she went into shock with a further drop in her blood pressure, tachycardia and tachypnea. She was intubated, mechanically ventilated and was treated with fluids, cardioversion and amiodarone. Empiric therapy with levofloxacin, amikacin and cefepime were initiated. In the urinalysis, the result of a rapid test for Streptococcus pneumoniae was positive. Etanercept treatment was suspended due to a possible adverse reaction associated with this drug. At the start of therapy her clinical condition improved slowly. On Day 28, the patient was afebrile and she was discharged from the intensive care unit. DISCUSSION: Most of the infections associated with etanercept therapy have been reported in patients with rheumatoid arthritis. Based on our observations, etanercept was the possible offender in the development of septic shock and respiratory failure in community-acquired pneumonia. There was a temporal relationship between exposure to the drug and onset of symptoms. Etanercept was the only drug administered before the septic shock developed. Based on the Naranjo algorithm, the adverse reaction could be considered possible. CONCLUSION: Patients initiated on etanercept should be counseled and receive appropriate screening before drug initiation. All febrile and newly occurring concomitant illnesses should be promptly evaluated. General practitioners should discontinue etanercept treatment and institute prompt and aggressive intervention if infection develops.