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Dimethyl fumarate (DMF) is a fumaric acid esters derivate approved for plaque psoriasis as first‐line systemic therapy. It has been available in Italy since 2017 and an increasing number of patients are treated with this drug. To evaluate DMF effectiveness, side effects and drug survival in a dermatological real‐life setting. We performed a retrospective multi‐center study in five dermatologic clinics in Emilia‐Romagna, Northern Italy, which included all consecutive patients affected by moderate–severe psoriasis treated with DMF. We assessed effectiveness (in terms of PASI50 and PASI75 in an intention to treat observation) and safety (occurrence of side effects) of DMF and their association with demographic and disease characteristics, mean daily dose taken and treatment discontinuation. We included 103 patients, 78 (75.72%) had at least one comorbidity including 19 (18.44%) with a history of cancer; the mean treatment duration was 23.61 ± 17.99 weeks (min 4, max 130) and the mean daily dose was 262.13 ± 190.94 mg. Twenty‐four patients (23.30%) reached PASI75 at week 12, while a further 18 patients (17.47%) reached it at week 26. Side effects occurred in 63 patients (61.16%), the most frequent were diarrhea, epigastric discomfort, nausea, and flushing. Sixteen patients (15.53%) showed an alteration of laboratory tests. In some cases side effects were transitory, while in 53 patients (51.45%) they led to cessation of therapy. The median daily dose showed a direct association with PASI50 achievement and an indirect association with treatment discontinuation. Our study shows the peculiarities of DMF in a real‐world setting: effectiveness is often reached after 12 weeks of treatment and side effects could limit the continuation of the therapy but, at the same time, DMF has no major contraindications and, due to the wide range of dosage, it can allow both to manage side effects and to personalize the prescription for each patient. [ABSTRACT FROM AUTHOR]

Background: Antiretroviral drug resistance mutations remain a major cause of treatment failure.Objectives: To evaluate the impact of NRTI resistance mutations on virological effectiveness of elvitegravir-containing regimens.Materials and Methods: We selected treatment-experienced HIV-1-infected patients starting elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF), with at least one protease/reverse transcriptase genotype available before switching and at least one HIV-1 RNA viral load (VL) measurement during follow-up. The primary endpoint was virological failure (VF), defined as one VL value of ≥1000 copies/mL or two consecutive VL values of >50 copies/mL.Results: We included 264 ART regimens: 75.6% male, median (IQR) age 47 years (39-53), 7 years (3-16) of HIV infection, nadir CD4+ 247 cells/mm3 (105-361), 81.5% with VL ≤50 copies/mL and 11.7% with at least one NRTI mutation at baseline. Eleven (5.2%) VFs occurred in virologically suppressed patients versus eight (15.1%) in viraemic patients. The estimated probability of VF at 48 weeks with versus without any NRTI mutation was 7.4% (95% CI 2.3-12.5) versus 3.8% (2.1-5.5) in virologically suppressed patients and 66.7% (39.5-93.9) versus 11.2% (6.5-15.9) (P<0.001) in viraemic patients. The only predictor of VF was time on therapy (per 1 year more, adjusted HR 1.14, 95% CI 1.02-1.27, P=0.024) in viraemic patients.Conclusions: A switch to E/C/F/TDF or E/C/F/TAF is safe for virologically suppressed patients without documented NRTI resistance, but not recommended in viraemic patients with a history of NRTI resistance. Although we did not detect a detrimental effect of past NRTI resistance in virologically suppressed patients, a fully active regimen remains preferred in this setting due to possible rebound of drug-resistant virus in the long term. [ABSTRACT FROM AUTHOR]

Purpose: The TRITRIAL study assessed the effects of beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) fixed combination in patients with chronic obstructive pulmonary disease (COPD) in a real-world setting, focusing on patient's experience and perspective through the use of patients reported outcomes., Patients and Methods: TRITRIAL was a multicenter, prospective, observational study conducted on patients with moderate-severe COPD treated with BDP/FF/G fixed therapy for 12 months. The main objective was to evaluate the impact of BDP/FF/G on health status through the COPD Assessment Test (CAT) score. Additional assessments included adherence and satisfaction, measured by the TAI-10/12 questionnaire and a specifically designed eight-item questionnaire, quality of life through the EQ-5D-5L test, sleep quality through the COPD and Asthma Sleep Impact Scale (CASIS), as well as safety and disease-related outcomes., Results: Data from 655 patients were analyzed in the study. The mean total CAT score significantly improved (from 22.8 at baseline to 18.1 at 6 months and 16.5 at 12 months; p < 0.0001), as well as all the eight CAT sub-items, which decreased on average by 0.5-0.9 points during the study. Adherence and usability of the inhaler also improved during the study, with a decrease in poor compliance (from 30.1% to 18.3%) and an increase in good compliance (from 51.8% to 58.3%) according to the TAI score. Patients also benefited from significantly improved quality of life (EQ Index from 0.70 to 0.80; EQ-5D VAS score from 55.1 to 63.1) and sleep quality (CASIS score from 41.1 to 31.8). Finally, patients reported a significant reduction in exacerbation during the study., Conclusion: TRITRIAL showed that the BDP/FF/G fixed combination is effective and safe in patients with moderate-severe COPD and poorly controlled disease, improving patients' HRQoL, sleep quality, adherence and inhaler usability and reducing COPD symptoms and the risk of exacerbation in a real-life setting., Competing Interests: LR has received grants/research support from Roche and Boehringer Ingelheim; he has received honoraria or consultation fees from Boehringer Ingelheim, Promedior, Biogen, FibroGen, Sanofi-Aventis, Promedior, RespiVant, Roche, Celgene, Nitto, and Veracyte. GC reports personal fees from Astra Zeneca, Sanofi, and GSK, outside the submitted work. AP, USA and EI are employees of Chiesi Italia, Parma, Italy. The other authors report no conflicts of interest in this work., (© 2024 Richeldi et al.)

Dimethyl fumarate (DMFu) is a substance with remarkable hygroscopicity and fungicidal power, which has recently showed to be a strong sensitizer to humans. The use of DMFu in little desiccant pouches, for e.g. in handbags or footwear boxes, might result in the contamination of leather products, with the subsequent exposure to consumers by contact. In 2009, 153 samples of desiccant material were collected from leather manufactures all over Italy and analyzed for DMFu. Results proved to fall in a wide range (0.14-7145 mg/kg). [ABSTRACT FROM AUTHOR]

Background: Several therapies are available for psoriasis, including in some countries oral fumaric acid derivatives (FADs). Even if FADs are not available in the Italian market, they can be prescribed and reimbursed by the National Health Service, on request from the treating physician, when considered as a valuable option in selected patient., Methods: We performed a retrospective analysis of the PsoReal registry data, restricted to adult psoriatic patients enrolled between 2009 and 2017. Demographic and clinical data were collected together with information on systemic therapies prescribed for psoriasis, drug shifts and adverse effects. We focused our analysis on FADs compared with other systemic drugs., Results: From the registry data, a total of 17,064 patients were extracted, and 11,592 patients (67.9%), fulfilled inclusion criteria. The majority of them had chronic plaque psoriasis, the mean disease duration was 17.1±12.6 years, and the mean PASI was 17.8±10.9, with 51.5% presenting a moderate Ps (PASI between 10 and 20). A total of 36 patients (0.3%) were treated by FADs. The average treatment duration of conventional (9.0±10.0 months) and biological agents (13.7±11.6 months) was lower compared to the duration of FADs (28.1±20.1, P value<0.001). FADs were used at an average dosage of 361.0±146.3 mg/day and FADs treated patients displayed an overall lower healthcare cost compared with other drugs., Conclusions: The current study confirms previous European data about efficacy and safety of FADs and suggests a decrease of healthcare costs for FADs treated patients as compared to other treatments.