Evaluation of the safety and effectiveness after switch from adalimumab originator to biosimilar SB5 in patients with inflammatory bowel disease in a real-life setting.

Background and study aims: Prospective data are lacking on evolution of trough levels, effectiveness, acceptance rate and patient satisfaction after switch from the adalimumab originator to a biosimilar in patients with inflammatory bowel disease. Patients and methods: Patients in clinical remission or stable response and treated with adalimumab originator in 2 Belgian centers were offered to participate in this phase IV, prospective trial in which patients were switched to adalimumab biosimilar SB5. The primary outcome was the description of adalimumab trough levels over time. Secondary outcomes were secondary loss of response, disease activity, patient satisfaction score and drug persistence over 12 months. Results: The study included 110 patients. Mean baseline adalimumab trough level was 9.21 µg/ml. Concentration remained within the therapeutic range over time. No changes were observed in disease activity scores nor in biochemical parameters over time. The acceptance rate of switch was 84.6%. By month 12, 74.5% was still treated with SB5. The most frequent reason for discontinuation was occurrence of adverse events. 50% of these adverse events were injection site pain. The local discomfort was only significant the first 30 minutes after injection. Satisfaction with the decision to switch to SB5 was high and remained stable over time. Conclusions: After being well informed the great majority of patients treated with the adalimumab originator is willing to switch to biosimilar SB5. In our study, there was a persistence rate of 75% over one year. The trough levels remained within the therapeutic range and no change in disease activity was seen over time.

[Management of sexual side effects of antidepressants]. / Prise en charge des effets secondaires sexuels des antidépresseurs.

Antidepressants are associated with a high risk of sexual dysfunction. Their sexual side effects are greatly underestimated in clinical practice because they are rarely discussed spontaneously by the patient and poorly investigated by clinicians. Nonetheless, they are responsible for a decrease in quality of life as well as a decrease in treatment adherence, leading to a risk of relapse or worsening of the treated mental pathology. This is particularly problematic as antidepressants are often needed on a long-term basis and spontaneous remission of these sexual side effects is low. Prevention, investigation and handling of sexual side effects are therefore important goals in the management of patients treated with antidepressants.

Les antidépresseurs sont associés à un risque élevé de dysfonctions sexuelles. Leurs effets secondaires sexuels sont largement sous-estimés dans la pratique clinique car ils sont rarement abordés spontanément par le patient et peu recherchés par les cliniciens. Ils sont pourtant responsables d'une baisse de la qualité de vie ainsi que d'une diminution de l'observance au traitement, entraînant un risque de rechute ou d'aggravation de la pathologie mentale traitée. Ceci est d'autant plus problématique que les antidépresseurs sont souvent nécessaires à long terme et que la rémission spontanée de ces manifestations indésirables est faible. La prévention, la recherche et la gestion des effets secondaires sexuels sont donc des enjeux importants dans la prise en charge de patients traités par antidépresseurs.

[Left ventricular non compaction: A poorly known cardiomyopathy]. / LE CAS CLINIQUE DU MOIS. La non-compaction du ventricule gauche: une cardiomyopathie méconnue.

Left ventricular non compaction is a rare congenital cardiomyopathy. It is characterised by a thin compacted epicardial layer, prominent trabeculations and deep recesses that communicate with the left ventricular cavity. This condition may lead to chronic heart failure, life threatening ventricular arrhythmias and systemic embolic events.

Towards the differentiation of non-treated and treated corundum minerals by ion-beam-induced luminescence and other complementary techniques.

Differentiation of treated and non-treated gemstones is a chief concern for major jewellery import companies. Low-quality corundum specimens coming from Asia appear to be often treated with heat, BeO or flux in order to enhance their properties as precious minerals. A set of corundum samples, rubies and sapphires from different origins, both treated and non-treated has been analysed at the Centre Européen d'Archéométrie, with ion-beam-induced luminescence (IBIL) and other complementary techniques such as Raman, proton-induced X-ray emission (PIXE), and proton-induced gamma-ray emission (PIGE). IBIL, also known as ionoluminescence, has been used before to detect impurities or defects inside synthetic materials and natural minerals; its use for the discrimination of gemstone simulants or synthetic analogues has been elsewhere discussed (Cavenago-Bignami Moneta, Gemología, Tomo I Piedras preciosas, perlas, corales, marfil. Ediciones Omega, Barcelona, 1991). PIXE has been frequently applied in the archaeometric field for material characterisation and provenance studies of minerals (Hughes, Ruby & sapphire. RWH Publishing, Fallbrook, 1997; Calvo del Castillo et al., Anal Bioanal Chem 387:869-878, 2007; Calligaro et al., NIM-B 189:320-327, 2002) and PIGE complements the elemental analysis by detecting light elements in these materials such as-and lighter than-sodium that cannot be identified with the PIXE technique (Sanchez et al., NIM-B 130:682-686, 1997; Emmett et al., Gems Gemology 39:84-135, 2003). The micro-Raman technique has also been used complementarily to ion beam analysis techniques for mineral characterisation (Novak et al., Appl Surf Sci 231-232:917-920, 2004). The aim of this study is to provide new means for systematic analysis of corundum gemstone-quality mineral, alternative to the traditional gemmologic methods; for this purpose, a Spanish jewellery import company supplied us with a number of natural corundum samples coming from different places (part of them treated as explained above). The PIXE elemental concentrations of the samples showed large quantities of calcium and lead in some cases that can be linked to treatment with fluxes or lead oxide. The plot of the chromium and iron concentration grouped the samples in various aggregates that corresponded to the different types of corundum analysed. Micro-Raman complemented the PIXE analysis corroborating the presence of lead oxides but the use of the PIGE technique was not successful for the detection of beryllium due to the low cross section of the nuclear reaction chosen for its identification. IBIL was capable of distinguishing between treated and non-treated samples of the same type based on the luminescent features of the materials.