Novartis (Italy)

We read with interest the recent study by Zaidman et al [...].

Background/Objective: Dabrafenib and trametinib (D + T) have been approved for the treatment of stage III melanoma with BRAF V600E V600K mutations in an adjuvant setting, based on the results from the COMBI-AD trial. To provide early access to this combination therapy prior to its commercial availability in Italy, a Managed Access Program (MAP) was run in Italy from June 2018 to December 2019. Methods: The MADAM (Maximing ADjuvAnt MAP) study is an Italian retrospective-prospective observational study that included patients who received at least one dose of D + T through the MAP. The primary endpoints were relapse-free survival (RFS) and overall survival (OS). Results: This interim analysis presents findings after the first 24 months of follow-up. A total of 310 patients were included in the study; 240 completed the 12-month treatment with D + T, while 70 discontinued the combination. RFS rates were 93.2% at 12 months and 80.2% at 24 months. The median RFS was not reached for the overall population or any subgroups. Similarly, the median OS was not reached, with OS rates of 96.4% at 12 months and 92.5% at 24 months. Conclusions: D + T achieved an RFS benefit, with effects sustained beyond the treatment period, indicating positive outcomes in this patient population.

ObjectiveThe growth of videoconferencing psychotherapy (VP) requires a closer conceptualization of the therapeutic relationship in VP. Therefore, we investigated the therapeutic relationship in VP from the clinicians’ perspective.MethodWe conducted three focus groups with 27 Italian VP professional psychotherapists of different theoretical orientations, focusing on their experience of the therapeutic relationship in VP. Data analysis was conducted through inductive thematic analysis.ResultsThe following themes emerged: (a) construction and management of the online setting (regarding the complexity of the therapeutic boundaries in VP and the efforts to manage this); (b) meaning construction of the request for help and the therapeutic process (regarding how patients and therapist represent the meaning of the therapeutic space and work in VP); (c) patient and therapist involvement in the online relationship (addressing the depth of the therapeutic relationship in VP in terms of intimacy, openness/closure, distance/closeness, and involvement); (d) new elements of the therapeutic relationship introduced by VP (regarding the source and nature of information about the patient and the effects of the technical environment on the relationship); (e) nonverbal aspects and corporeality in VP (dealing with how different aspects of para- and extralinguistic communication may impact the therapeutic relationship in VP); (f) differences in the quality of the emotional and relational level of VP (regarding the emotional attitudes and reactions of patients and therapists and the overall quality of the therapeutic relationship); (g) treatment satisfaction and drop-out (regarding ease of leaving the session, patient satisfaction, and dificulties in terminating therapy); and (h) personal characteristics of patient and therapist that influence VP (regarding the impact of patients personality and therapists training/approach on the progress of VP).ConclusionsResults suggest that the therapeutic relationship in VP has specific features that distinguish it from face-to-face psychotherapy. Implications for practice, training, and research are discussed.

Hidradenitis suppurativa (HS) is a persistent skin disorder that is characterized by painful lesions or pus-filled lumps, mostly occurring in areas where the skin flexes. It is a disfiguring condition that significantly reduces the quality of life of those affected. Developing new, effective treatments for HS is crucial, but it is important that it be recognized and diagnosed early, especially in primary care settings. To assess the epidemiology and clinical correlates of HS in a primary care setting. The study utilized the Italian Health Search Database (HSD). A case-control design was adopted to investigate the clinical correlates of HS. Cases were classified as either "definite" or "probable" using an operational algorithm. Up to 10 controls were matched to each case based on factors such as calendar period, age, sex, and duration of follow-up. Cumulative prevalence of HS increased from 0.06% in 2002 to 0.46% in 2021. When only "definite" cases were considered, the prevalence was almost 10 times lower (0%-0.02%). Several clinical correlates were found to be positively associated with HS, including obesity, dyslipidemia, hypertension, autoimmune/inflammatory diseases, and depression. This study found that correct diagnoses of HS were made, as demonstrated by the expected relationship with clinical correlates. These associations were consistent when probable cases were included in the analysis. This evidence could serve as a foundation for proposing a decision support system for general practitioners to help identify HS in individuals with certain coexisting conditions.

IntroductionPsoriasis (PsO) is an immune-mediated chronic inflammatory disease that results in severe outcomes that impact the patient’s quality of life and work productivity. We investigated the effectiveness of secukinumab in patients with chronic plaque psoriasis and psoriatic arthritis (PsA) over a 12-month period.MethodsThis was a longitudinal, retrospective study of the medical records of 81 patients with psoriasis and/or psoriatic arthritis who had been treated with secukinumab for at least 12 weeks.ResultsThe Psoriasis Area Severity Index (PASI), Body Surface Area (BSA) percentage, and Dermatology Quality of Life Index (DLQI) among patients with PsO and PsO-PsA showed a statistically significant decrease from baseline over 12 months by approximately 9.86, 19.3%, and 9.7, respectively (p values < 0.001 for each). Moreover, there was a statistically significant decrease in the overall Disease Activity in Psoriatic Arthritis score (DAPSA) by approximately 22.35 from baseline over 12 months of treatment (p < 0.001). Considering the patients who started secukinumab 12 months or more prior to the study cutoff date, the 12-month retention rate was 85%.ConclusionIn a Saudi real-world setting, secukinumab proved to be an efficient medication with high efficacy and retention rates.

PurposeReal-world data from patients with BRAFV600-mutated, resected, stage III melanoma treated with dabrafenib plus trametinib as adjuvant targeted therapy are limited, and it is important to gain an understanding of the characteristics of this patient population, as well as of the patient journey. Here we aimed to describe the characteristics, dosage reductions and discontinuations in patients with BRAFV600E/K-mutated melanoma receiving adjuvant dabrafenib plus trametinib after surgical resection through an Italian managed access program (MAP).Patients and MethodsEligible patients had completely resected cutaneous melanoma with confirmed BRAF V600E or V600K mutation, or initially resectable lymph node recurrence after a diagnosis of stage I or II melanoma. The starting dose of dabrafenib and trametinib was 150 mg twice daily and 2 mg once daily, respectively.ResultsA total of 557 patients received dabrafenib plus trametinib through the MAP (stage III resected disease at inclusion, 554). Median age was 54.0 years, and 40.2% of patients were female. The proportion of all treated patients who required a dose reduction was low (10.8%) as was the proportion of patients who discontinued treatment (13.5%). The main reason for treatment discontinuation was adverse events (36.0%).ConclusionNew treatments, including BRAF-targeted therapies and immunotherapy, have transformed the natural history of melanoma. This is the largest study to date describing patients treated with dabrafenib plus trametinib in routine clinical practice in Italy between 2018 and 2019. Results highlight the characteristics of the patients treated and their journey, as well as the tolerable safety profile of dabrafenib plus trametinib in a real-world patient population.