Long-Term Drug Survival and Effectiveness of Secukinumab in Patients with Moderate to Severe Chronic Plaque Psoriasis: 42-Month Results from the SUPREME 2.0 Study

Purpose: SUPREME, a phase IIIb study conducted in Italy, demonstrated safety and high efficacy of secukinumab for up to 72 weeks in patients with moderate-to-severe plaque-type psoriasis. SUPREME 2.0 study aimed to provide real-world data on the long-term drug survival and effectiveness of secukinumab beyond 72 weeks. Patients and Methods: SUPREME 2.0 is a retrospective observational chart review study conducted in patients previously enrolled in SUPREME study. After the end of the SUPREME study, eligible patients continued treatment as per clinical practice, and their effectiveness and drug survival data were retrieved from medical charts. Results: Of the 415 patients enrolled in the SUPREME study, 297 were included in SUPREME 2.0; of which, 210 (70.7%) continued secukinumab treatment throughout the 42-month observation period. Patients in the biologic-naïve cohort had higher drug survival than those in the biologic-experienced cohort (74.9% vs 61.7%), while HLA-Cw6–positive and HLA-Cw6–negative patients showed similar drug survival (69.3% and 71.9%). After 42 months, Psoriasis Area and Severity Index (PASI) 90 was achieved by 79.6% of patients overall; with a similar proportion of biologic-naïve and biologic-experienced patients achieving PASI90 (79.8% and 79.1%). The mean absolute PASI score reduced from 21.94 to 1.38 in the overall population, 21.90 to 1.24 in biologic-naïve and 22.03 to 1.77 in biologic-experienced patients after 42 months. The decrease in the absolute PASI score was comparable between HLACw6–positive and HLA–Cw6-negative patients. The baseline Dermatology Life Quality Index scores also decreased in the overall patients (10.5 to 2.32) and across all study sub-groups after 42 months. Safety was consistent with the known profile of secukinumab, with no new findings. Conclusion: In this real-world cohort study, secukinumab showed consistently high long-term drug survival and effectiveness with a favourable safety profile

What is the role of the placebo effect for pain relief in neurorehabilitation? Clinical implications from the Italian consensus conference on pain in neurorehabilitation

Background: It is increasingly acknowledged that the outcomes of medical treatments are influenced by the context of the clinical encounter through the mechanisms of the placebo effect. The phenomenon of placebo analgesia might be exploited to maximize the efficacy of neurorehabilitation treatments. Since its intensity varies across neurological disorders, the Italian Consensus Conference on Pain in Neurorehabilitation (ICCP) summarized the studies on this field to provide guidance on its use. Methods: A review of the existing reviews and meta-analyses was performed to assess the magnitude of the placebo effect in disorders that may undergo neurorehabilitation treatment. The search was performed on Pubmed using placebo, pain, and the names of neurological disorders as keywords. Methodological quality was assessed using a pre-existing checklist. Data about the magnitude of the placebo effect were extracted from the included reviews and were commented in a narrative form. Results: 11 articles were included in this review. Placebo treatments showed weak effects in central neuropathic pain (pain reduction from 0.44 to 0.66 on a 0-10 scale) and moderate effects in postherpetic neuralgia (1.16), in diabetic peripheral neuropathy (1.45), and in pain associated to HIV (1.82). Moderate effects were also found on pain due to fibromyalgia and migraine; only weak short-term effects were found in complex regional pain syndrome. Confounding variables might have influenced these results. Clinical implications: These estimates should be interpreted with caution, but underscore that the placebo effect can be exploited in neurorehabilitation programs. It is not necessary to conceal its use from the patient. Knowledge of placebo mechanisms can be used to shape the doctor-patient relationship, to reduce the use of analgesic drugs and to train the patient to become an active agent of the therapy

What is the role of the placebo effect for pain relief in neurorehabilitation? Clinical implications from the Italian Consensus Conference on Pain in Neurorehabilitation

Background: It is increasingly acknowledged that the outcomes of medical treatments are influenced by the context of the clinical encounter through the mechanisms of the placebo effect. The phenomenon of placebo analgesia might be exploited to maximize the efficacy of neurorehabilitation treatments. Since its intensity varies across neurological disorders, the Italian Consensus Conference on Pain in Neurorehabilitation (ICCP) summarized the studies on this field to provide guidance on its use. Methods: A review of the existing reviews and meta-analyses was performed to assess the magnitude of the placebo effect in disorders that may undergo neurorehabilitation treatment. The search was performed on Pubmed using placebo, pain, and the names of neurological disorders as keywords. Methodological quality was assessed using a pre-existing checklist. Data about the magnitude of the placebo effect were extracted from the included reviews and were commented in a narrative form. Results: 11 articles were included in this review. Placebo treatments showed weak effects in central neuropathic pain (pain reduction from 0.44 to 0.66 on a 0-10 scale) and moderate effects in postherpetic neuralgia (1.16), in diabetic peripheral neuropathy (1.45), and in pain associated to HIV (1.82). Moderate effects were also found on pain due to fibromyalgia and migraine; only weak short-term effects were found in complex regional pain syndrome. Confounding variables might have influenced these results. Clinical implications: These estimates should be interpreted with caution, but underscore that the placebo effect can be exploited in neurorehabilitation programs. It is not necessary to conceal its use from the patient. Knowledge of placebo mechanisms can be used to shape the doctor-patient relationship, to reduce the use of analgesic drugs and to train the patient to become an active agent of the therapy

Vers un modèle ethnographique-écologique d’une société pastorale préhistorique

La réalisation complète d’une archéologie des communautés pastorales est fruit d’une profonde intégration d’enquêtes multidisciplinaires. Le but de cet article est l’application flexible et continue des données ethnographiques, écologiques et ethno-historiques à un cas archéologique. En particulier, on propose une révision d’une société pastorale préhistorique du Vie millénaire BP à la lumière des informations de nature extra-archéologique afin d’évaluer la consistance et la qualité de l’occupation humaine dans un contexte régional déterminé. Le parcours opératif ici présenté se configure comme un instrument interprétatif stimulant, surtout pour l’ample portée du modèle qu’il comprend. Les aspects problématiques du procédé sont considérés et examinés dans le cadre théorique et méthodologique de l’ethnoarchéologie, en rapport à des situations africaines actuelles

Reflections on the Takarkori rockshelter (Fezzan, Libyan Sahara).

Rockshelters have hosted ancient Saharans since the Late Pleistocene. After a long hiatus, human occupation of such sites was remarkable during the Holocene, when hunter-gatherers and pastoralists exploited rockshelters in different manners. Italian scholars have been excavating these locations since the 1950s, shedding light on various aspects of the archaeology of the region. Fresh data have emerged from the excavation of the Takarkori rockshelter, located in the Acacus Mts. (southwestern Fezzan, Libya), which is presently under excavation. Shifts in the shelter’s use throughout the Holocene will be discussed and weighed against our current knowledge of the whole region, accumulated over decades of research

COMBINING INTENSIVE FIELD SURVEY AND DIGITAL TECHNOLOGIES: NEW DATA ON THE GARAMANTIAN CASTLES OF WADI AWISS, ACACUS MTS., LIBYAN SAHARA

In recent years, Garamantian archaeology has received renewed attention from historians and archaeologists, particularly in the south-western corner of Libya in the central Sahara. This paper focuses on the potential of intensive field surveys and digital technologies as applied to a particular segment of the Garamantian state: the 'castles' of Wadi Awiss and their associated contexts - necropoleis and site remains. The combination of a field survey, selected settlement soundings and territorial funerary data provided additional information on the chronological and functional organization of the Garamantian system

Unearthing the hearths: preliminary results on the Takarkori rockshelter fireplaces (Acacus Mts., Libya)

From a methodological viewpoint, fireplaces are of the utmost importance for the understanding of formation processes. In arid environments, these are characterised by complex post-depositional phenomena and erosional events. Given their peculiar nature (positive stratigraphic evidence; high possibility of dating), fireplaces may play a key role in decoding multifaceted, often sandy and loose palimpsests. In-depth analysis of this feature may also yield important indications of type of action, re-cycling activity and site organization. The preliminary results from the excavations at Takarkori, a rockshelter with evidence of human occupation from 8800 to 4000 uncalibrated years bp, brought up the problem of the nature and meaning of this facility

Decoding an Early Holocene Saharan stratified site. Ceramic dispersion and site formation processes in the Takarkori rock-shelter (Acacus Mountains, Libya).

The surface pottery from a well-preserved Holocene archaeological site in south-western Libya is analysed. The collection suggests a long and protracted human occupation of the shelter, from Late Acacus (Mesolithic) hunter-gatherers to Late Pastoral (Neolithic) herders. Aim of the work is to decode the dynamic history of the site via the study of its surface elements, both artefacts and ecofacts, and the way they interacted over the millennia. To do this, traditional ceramic analysis is combined with recently developed methods of description imported from sedimentology, stressing the potentialities of surface archaeological material. In this framework, spatial analysis of scattered potsherds, in connection with their quantitative and qualitative features and chronological attribution, appears of main relevance in the analysis of site formation processes and post-depositional events that altered the archaeological deposit, transforming its present surface