Treatment Satisfaction Questionnaire Research Articles

P0709 Patient Satisfaction with Subcutaneous versus Intravenous Vedolizumab: A Prospective Observational Study

Abstract Background Vedolizumab (VDZ) is a selective biologic agent that is available in both intravenous (IV) and subcutaneous (SC) forms for maintenance treatment. The SC route offers advantages such as the convenience of self-administration, although some patients may prefer the IV route. The aim of our study was to determine patients’ preferences and satisfaction with their treatment when switching to VDZ SC or continuing with an IV administration. Methods A prospective, observational study was conducted in patients with inflammatory bowel disease (IBD) receiving VDZ IV who were in clinical remission. Patients had the option to continue with VDZ IV or switch to SC and were grouped according to their preference. A baseline visit (before the switch) and another at 24 weeks were conducted. During both visits, patients completed the treatment satisfaction questionnaire (SATMED-Q) and quality of life questionnaire (IBDQ9). Clinical activity, treatment adherence, adverse effects, general bloodwork, and fecal calprotectin were also analyzed. Results Forty-one IBD patients were included, 43% of which were women, and 63% had ulcerative colitis. Almost half (41%) continued with VDZ IV while 59% switched to SC. There were no differences in gender, type, or characteristics of IBD between the groups. However, the age of patients in the SC group was significantly younger than that of the IV group (median 46 [32-63] vs. 66 [59-77] p=0.03). Fewer patients in the SC group had previously received IV biologics (SC 31% vs. IV 69%, p=0.012). The median SATMED-Q before the switch was lower in the SC group (SC 53 [40-61] vs. IV 61 [46-64], p=0.032), as was the IBDQ9 (SC 65.5 [59.4-68.5] vs. IV 70.8 [68.5-77.1], p=0.037). At 24 weeks, there were no differences in SATMED-Q or IBDQ9 scores or disease clinical activity. Drug persistence and frequency of adverse events were similar in both groups. Vedolizumab levels increased significantly in the SC group at 24 weeks (p=0.041). Conclusion Switching to VDZ SC showed similar treatment satisfaction to VDZ IV at 24 weeks in IBD patients, with comparable clinical outcomes and safety profiles. There was a clear preference for subcutaneous administration among younger patients and those without previous IV treatment. This suggests that patient demographics and prior treatment experiences can influence the choice of administration route. The lack of significant differences in clinical outcomes, quality of life scores, and treatment satisfaction between the SC and IV groups at 24 weeks highlights the clinical equivalence of these two administration routes for maintenance therapy in IBD.

Patient-Reported Outcome Measures in Patients with Diabetes Mellitus: Findings from the Diabetes Landeck Cohort.

Maintaining and optimizing quality of life (QoL) is a central issue and one of the most important goals in therapy for patients with chronic diseases, such as diabetes mellitus (DM). Despite its importance, there is little data on the QoL of patients with DM in Austria. The objective of this study was to extend an established population-based cohort, the Diabetes-Landeck cohort, by including patient-reported outcomes. We performed a survey on quality of life (QoL) and treatment satisfaction in patients from the Diabetes-Landeck cohort using the EQ-5D-5L, the problem areas in diabetes survey (PAID), and the diabetes treatment satisfaction questionnaire (DTSQ). Mean sum scores were calculated and compared between patient characteristic subgroups. In total 58 patients were recruited, with a mean age of 63 years and a mean hemoglobin A1c (HbA1c) of 7.1%. The mean sum score of EQ-5D-5L was 92 (SD=10.6), and that of DTSQ and PAID were 32.2 (SD=6.6) and 10.8 (SD=11.6), respectively. Patients with obesity (body mass index ≥ 30 kg/m2) showed a statistically significant decreased mean sum score of EQ-5D-5L and a statistically significant increased mean sum score of DTSQ. Patients with HbA1c ≥7.5% showed a statistically significant decreased mean sum score of DTSQ. We observed patient-reported outcomes significantly associated with obesity and HbA1c, which could be used for targeted patient monitoring. Limited by small sample size and questions in generalizability, we strongly suggest the rollout of a larger study.

Early and Sustained Treatment Satisfaction Observed in Patients With Moderate to Severe Psoriasis Treated With Ixekizumab: Results From Second Interim Analysis of the Real-World Psoriasis in Special Areas (PSoSA) Study

Introduction: Psoriasis (PsO) is an inflammatory disease that affects 3.2% of the US adult population (1). Patients treated with biological agents show higher treatment satisfaction over those treated with oral therapy, phototherapy and topical therapy (1). Ixekizumab has proven to be effective in treating moderate-to-severe plaque PsO in clinical trials. This analysis describes treatment satisfaction with ixekizumab in a real-world population using the IDEOM-7 (International Dermatology Outcomes Measures) treatment satisfaction questionnaire (2). Methods: The Psoriasis in Special Areas (PSoSA) study is a US-based, 52-week (W), prospective, multicenter, single-arm, observational study that enrolled adults with moderate-to-severe plaque PsO and nail involvement, with/without scalp involvement, in patients who initiated ixekizumab. Here, we describe observed data from the second interim analysis of the PSoSA study. Treatment satisfaction is measured using DermStat-7 also referred as IDEOM-7, a 7-item questionnaire completed by patients to assess overall treatment satisfaction using a 5-point response option from 1 “not satisfied”, 2 “slightly satisfied”, 3 “somewhat satisfied”, 4 “mostly satisfied” to 5 “completely satisfied”. This questionnaire is a novel method for assessing effectiveness of treatment (3 items), convenience of treatment (3 items), and a single item assessing overall satisfaction. Patients were requested to complete the IDEOM-7 at each follow-up visit. Here we describe results from the 2nd interim analysis for patients with available data at W4, W12, and W24 based on responses to the questions. Results: At W4, 146 patients were analysed. 80.9% (n=106) of the patients treated with ixekizumab responded as “mostly or completely satisfied”, 11.5% (n=15) as “somewhat satisfied”, 6.1% (n=8) as “slightly satisfied” and 1.5% (n=2) as “not satisfied”. At W12, 115 patients were analysed. 85.3% (n=93) of the patients treated with ixekizumab responded as “mostly or completely satisfied”, 7.3% (n=8) as “somewhat satisfied”, 3.7% (n=4) as “slightly satisfied” and 3.7% (n=4) as “not satisfied”. At W24, 71 patients were analysed. 86.4% (n=57) of the patients treated with ixekizumab responded as “mostly or completely satisfied”, 9.1% (n=6) as “somewhat satisfied”, 1.5% (n=1) as “slightly satisfied” and 3% (n=2) as “not satisfied”. Conclusion: In this second interim analysis of the PSoSA study, moderate to severe PsO patients initiating ixekizumab reported high levels of overall treatment satisfaction as early as week 4 which was sustained at week 24. Florek AG, Wang CJ, Armstrong AW. Treatment preferences and treatment satisfaction among psoriasis patients: a systematic review. Archives of Dermatological Research. 2018 May;310:271-319. Ball GD, Yee D, Zhang AJ, Perez-Chada LM, Strand V, Merola JF, Armstrong AW, Gottlieb AB. Report of the IDEOM meeting adjacent to the GRAPPA 2023 annual meeting. The Journal of Rheumatology. 2024 Jul 15.

Effectiveness, safety, and patient-reported outcomes of bictegravir/emtricitabine/tenofovir alafenamide in routine clinical care in Italy: 12-Month results from the BICSTaR cohort.

BICSTaR is a multi-national, observational cohort evaluating the effectiveness, safety, and patient-reported outcomes (PROs) in treatment-naïve (TN) and -experienced (TE) people with HIV-1 receiving bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in routine clinical care. We present the 12-month (M12) outcomes of the Italian BICSTaR cohort. Participants initiating B/F/TAF in routine care were prospectively followed. Outcomes included virological and immunologic effectiveness, drug-related adverse events (DRAEs), treatment persistence, and PROs using the HIV Symptom Index (HIV-SI) and the HIV Treatment Satisfaction Questionnaires (HIVTSQ). N = 201 were included (29TN, 172TE), 83% male, median age 38 years in TN, 48 years in TE. At baseline, 94% of TE had an HIV-1 RNA <50 cp/mL, 92% switched to B/F/TAF for simplification. Overall, 69% reported comorbidities (TN: 59%, TE: 70%). At M12, 88% (23/26) of TN and 96% (152/159) of TE had an HIV-1 RNA <50 cp/mL in the discontinuation = failure analysis (without emergence of resistance to B/F/TAF). Median CD4 count changes were +296 cells/µL (interquartile range [IQR], 118, 383) in TN, and +23 cells/µl (-137, 114) in TE. DRAEs were reported for 5% and led to discontinuation in 1%. M12 persistence on B/F/TAF was 97%. TN had a median HIV-SI bothersome symptom count decrease of -1.5 (IQR, -5.0, 0.0). Median treatment satisfaction change score was +29.0 (21, 30) in TE indicating an improvement. In this real-world Italian cohort of mostly treatment-experienced people switching for simplification, B/F/TAF demonstrated high effectiveness and persistence over 12 months and confirmed the favourable safety profile shown in clinical trials. European cohort: EUPAS22185.

The novel manualized RELIEVE-group treatment for burdened relatives of cancer patients: a feasibility study.

The experience of cancer among relatives is characterized by an increase in anxiety and depression, stress, and a reduction in quality of life. However, there is a paucity of psychosocial support programmes for relatives and a dearth of evidence-based, manualized interventions. Accordingly, the present study aims to assess the acceptability, defined as participant drop-out and satisfaction, and feasibility, in terms of mental health improvement, of a novel manualized psycho-educational group intervention. The manual was developed on the basis of previous research into psychotherapy. A total of 33 relatives of cancer patients were recruited from the West German Tumor Center and participated in the five modules of the RELIEVE treatment which included an introduction, communication skills, stress and anxiety management and self-care. The primary outcome was assessed using a range of measures, including anxiety (GAD-7), depression (PHQ-8), stress (PSQ), self-efficacy (SES), need for support (SCNSP&C-G), and quality of life (WGOQOL-BREF) before and after the completion of the treatment programme. A paired samples T-test was employed to assess the feasibility of the treatment, with pre- and post-scores being compared. The secondary outcome of treatment acceptance was evaluated by calculating the drop-out rate and scoring a treatment satisfaction questionnaire. A high level of satisfaction was reported by participants. The drop-out rate for the treatment was minimal, at only 2.86%. Following the completion of the treatment programme, there were significant improvements in anxiety, depression and stress scores, as well as an improvement in quality of life. No significant improvements were observed in self-efficacy, work and social security needs, and quality of life in the social relationships domain. The RELIEVE intervention demonstrated high feasibility and acceptance among emotionally affected relatives of cancer patients, addressing a gap in previous interventions that were often limited in scope and lacked standardised manuals. This feasibility study on treatment acceptance underlines the importance of measures that are tailored to the specific needs of cancer patients' relatives, and of integrating them into the general healthcare system.

Level of Satisfaction Among Patients Using Insulin Administered by Pen vs Vial/Syringe. An Observational Prospective Study.

To determine the satisfaction of patients with diabetes mellitus who used subcutaneous insulin application devices in Colombia. An observational prospective study of patients with diabetes mellitus receiving insulin treatment in Colombia. Sociodemographic, comorbidity and pharmacological data were taken from a drug dispensing database. Through telephone calls, satisfaction with application devices was evaluated with Diabetes Treatment Satisfaction Questionnaire status version (DTSQ-s). Satisfaction was considered high at a score ≥30 points. The change in the type of insulin delivery device (ie, from pen to vial/syringe, and from vial/syringe to pen) was evaluated during a 1-year follow-up. A total of 382 patients from 75 cities were selected, with a median age of 66.0 years, and 56.3% were women, and 65.2% were treated with long-acting insulins. The mean DTSQ-s score was 26.6±5.3 points, and 38.7% presented high satisfaction, without statistically significant differences between pen and vial/syringe. A total of 18.8% changed the administration device, mainly those that came from Bogotá-Cundinamarca (OR:2.19; 95% CI:1.01-4.75), in concomitant treatment with other antidiabetic drugs (OR:2.28; 95% CI:1.00-5.22) and those who previously used insulin in vial/syringe (OR:33.90; 95% CI:11.88-96.74). The participants had low satisfaction with the insulin delivery device. No statistically significant differences were found in satisfaction between those who received pen vs vial/syringe insulin, and patients using the latter had a high probability of switching to insulin pen.

Effect of alemtuzumab on fatigue, quality of life, and patient/caregiver-reported outcomes in relapsing-remitting multiple sclerosis – a real-world evidence study

BackgroundAlemtuzumab is approved in the European Union for treating highly active relapsing-remitting multiple sclerosis (RRMS). Patient-reported outcomes measure the treatment impact on quality of life (QoL), including fatigue, a common symptom in multiple sclerosis (MS). Chronic diseases like MS also affect the patient's caregiver. Thus, understanding the impact on both patients and caregivers is essential for a comprehensive view of MS treatment outcomes. MethodsThis multi-center prospective, observational study assessed RRMS patients undergoing alemtuzumab treatment, and their caregivers across three European countries (Denmark, Norway, and Italy). The study visits were conducted at baseline, and at Months 3, 6, 12, 18, 24, and 36 (± 1 month). The primary endpoint assessed the effect of alemtuzumab on MS-related fatigue (Fatigue Scale for Motor and Cognitive Functions [FSMC] score). Secondary endpoints included changes in cognition (Symbol Digit Modalities Test [SDMT]), depression (Beck Depression Inventory-Version II [BDI-II]), QoL (29-item Multiple Sclerosis Impact Scale [MSIS-29]), treatment satisfaction (Treatment Satisfaction Questionnaire for Medication [TSQM]), working capacity/daily life activity (Health-Related Productivity Questionnaire [HRPQ]), and clinical evaluation (number of relapses, improvement in Expanded Disability Status Scale [EDSS] score, and need for re-treatment with alemtuzumab/any other treatment). Exploratory endpoints included caregiver perception of patient's QoL, caregiver QoL, and caregiver burden. The sample size (N=80) was determined based on the 2-sided t-test at 5% significance level. Data were analyzed descriptively. Safety was also evaluated. ResultsOf 87 enrolled patients, 72.4% (n=63) completed all follow-ups. Significant improvement was observed in fatigue (p<0.01), with a median (min, max) FSMC score change of -7.3 (-56.0, 34.0) units at the end-of-study (EOS), and clinically relevant improvement (≥ 9 units) noted in approximately 12.5 months. SDMT (3-5 units, p<0.05), BDI-II (median score of 9.5, i.e., no depression, p<0.01), and MSIS-29 (median change in physical and psychological impact scores -9.2, p<0.01 and -14.8, p<0.001, respectively) improved significantly from baseline to EOS. Global treatment satisfaction (p<0.001), effectiveness (p<0.05), and side effects (p<0.05) significant improved exept at EOS, whereas treatment convenience remained same throughout the study. The percentage of patients with at least one relapse was similar each year of the study (10.8%-13.2%). A statistically significant improvement (p<0.05) in EDSS was reported over time. At EOS, 4.5% patients needed retreatment with alemtuzumab. Caregivers also reported improvement in patients’ QoL over time, but the median change from baseline (physical and psychological impact scores: -10.0 and -14.8, respectively) was not statistically significant (p>0.05). Caregivers reported similar QoL and caregiver burden at baseline and EOS, apart from an increase in emotional QoL. Headache (51.2%), pyrexia (44.2%), and rash (34.9%) were the most common adverse events (AEs). Majority of the AEs were either mild or moderate, apart from 25 severe AEs. Three patients discontinued prematurely, of which one patient died of sepsis related to treatment. ConclusionThis real-world study showed beneficial impact of alemtuzumab on fatigue, cognition, depression, QoL, and treatment satisfaction. Improvement in patient disability, and caregiver-reported outcomes indicated enhanced patients’ QoL.

Improved glycaemic control in people with type 2 diabetes initiating or switching to IDegAsp in a real-world setting in China.

To investigate glycaemic control in Chinese adults with type 2 diabetes (T2D) initiating, or switching to insulin degludec/insulin aspart (IDegAsp), a co-formulation of basal, and bolus insulin, in a real-world setting. A 20-week, prospective, single-arm, open-label, non-interventional study was conducted in Chinese adults with T2D initiating, or switching to IDegAsp after anti-hyperglycaemic treatment with oral antidiabetic drugs (OADs), other insulins, or glucagon-like peptide-1 receptor agonists. The primary endpoint was a change in HbA1c from baseline to end of the study; the secondary endpoints included a change in fasting plasma glucose and Diabetes Treatment Satisfaction Questionnaire (DTSQ) score. Significant reductions were observed in mean HbA1c and fasting plasma glucose, among both the overall population (N = 878; -1.27%-points [95% CI: -1.36; -1.19]; p < 0.0001, and -1.61 mmol/L [95% CI: -1.81; -1.41]; p < 0.0001, respectively), and in subgroups switching from OADs only, or basal, or premix insulins ± OADs. The mean total DTSQ score increased from 26.4 (baseline) to 31.6 (end-of-study). No significant, or unexpected tolerability, or safety issues were observed. Significant reductions were observed in incidence rates of non-severe (rate ratio 0.37 [95% CI: 0.24; 0.59]; p < 0.0001) and nocturnal non-severe (rate ratio 0.45 [95% CI: 0.21; 0.94]; p = 0.0326) hypoglycaemic episodes. In a broad, real-world Chinese population of adults with T2D, initiating or switching to IDegAsp was associated with improved glycaemic control and lower rates of hypoglycaemia. The use of IDegAsp could be an effective treatment option for those with suboptimal glycaemic control or therapeutic inertia.

Psychometric evaluation of the Swedish version of the Diabetes Treatment Satisfaction Questionnaire - Parent version.

Psychometric evaluation of the Swedish version of the Diabetes Treatment Satisfaction Questionnaire - Parent version.

HIV treatment satisfaction: HIVTSQ-12 factor analysis and associated factors in Türkiye

BackgroundDespite global efforts, HIV/AIDS remains a significant public health challenge, with Türkiye witnessing a consistent rise in annual diagnoses. Patient satisfaction with antiretroviral therapy (ART) is crucial for treatment adherence and effectiveness. This study examines treatment satisfaction levels among people living with HIV (PLWH) in Türkiye and identifies associated factors.Materials and methodsA cross-sectional prospective cohort study was conducted at Tepecik Training and Research Hospital, Izmir, Türkiye, involving 238-PLWH receiving ART. Data were collected through face-to-face interviews using the HIV Treatment Satisfaction Questionnaire (HIVTSQ-12) and demographic/clinical forms. Confirmatory Factor Analysis and descriptive statistics were employed for data analysis.ResultsParticipants exhibited high overall treatment satisfaction, with significant associations between satisfaction levels and socio-demographic/clinical factors. Individuals with lower education levels, no substance use, minimal alcohol consumption, and suppressed viral loads reported higher satisfaction scores.ConclusionThis study highlights the potential for personalizing HIV treatment strategies based on socio-demographic and clinical factors. Findings emphasize the need to promote healthy lifestyles, enhance health literacy, and implement anti-addiction programs to improve treatment adherence and satisfaction among PLWH. Based on the findings, there is a need to develop strategies aimed at improving treatment satisfaction and outcomes in HIV management.

Booster-free anti-retroviral therapy for persons living with HIV and multidrug resistance (B-Free): protocol for a multicentre, multistage, randomised, controlled, non-inferiority trial

IntroductionAnti-retroviral therapy (ART) simplification strategies are needed for treatment-experienced people with HIV (PWH) and multidrug-resistant viruses. These individuals are commonly treated with boosted ART regimens and are thereby at risk...

Flash glucose monitoring system help reduce the frequency of hypoglycemia and hypoglycemic fear behavior in type 1 diabetes patients.

Hypoglycemia represents a serious acute complication in individuals with type 1 diabetes mellitus (T1DM). In order to more effectively identify and discriminate the occurrence of hypoglycemic events in patients with T1DM, this study aims to evaluate the impact of two distinct glucose monitoring systems-Flash Glucose Monitoring (FGM) and Continuous Glucose Monitoring (CGM)-on the management of blood glucose levels and the emotional responses associated with hypoglycemic episodes in individuals with T1DM. In this study, a total of 113 patients with type 1 diabetes mellitus were enrolled and allocated to two groups for the implementation of Glucose Monitoring Systems (GMS). The groups consisted of the FreeStyle Libre group (FGM, n=56) and the ipro2 group (CGM, n=57). Participants in both groups utilized GMS at least biannually and completed a set of three questionnaires: the Diabetes Monitoring and Treatment Satisfaction Questionnaire (DMTSQ), the Diabetes Specific Quality of Life (DQOL), and the Chinese Version of the Hypoglycemia Fear Survey II (CFHSII). Clinical data, CGM metrics, and questionnaire scores were collected at the initial visit and after a one-year follow-up period. The glucose coefficient of variation (GCV) and the standard deviation of blood glucose (SDBG) were independently associated with Time Below Range (TBR). Specifically, GCV could predict TBR ≥12%, with a cut-off point of 40.55. This yielded a specificity of 88.10% and a sensitivity of 68.18% in the overall patient population. For the FreeStyle Libre group and the iPro2 group, the cut-off points were 38.69 and 40.55, respectively, with specificities of 0.74 and 0.92, and sensitivities of 0.73 and 0.86, respectively. In the FreeStyle Libre group, where the frequency of use was greater than or equal to five times per year, the hypoglycemic episodes (time/month) and CHFSII-B scores were significantly reduced at follow-up compared to baseline (7.80 ± 10.25 vs 13.95 ± 14.87; 27.37 ± 11.05 vs 38.90 ± 21.61, respectively, all P <0.05). The utilization of multiple Flash Glucose Monitoring (FGM) implementations proved to be valuable in discriminating the occurrence of hypoglycemia and mitigating the fear of hypoglycemic episodes in patients with type 1 diabetes. Within the parameters of Glucose Monitoring Systems (GMS), the glucose glycemic variability (GCV) was identified as a predictive factor for the risk of severe hypoglycemia (TBR > 12%). The optimal cut-off point for GCV was determined to be 40.55.

Abstract 4136334: Treatment Satisfaction With an “Inclisiran First” Implementation Strategy Versus Usual Care in Patients With Atherosclerotic Cardiovascular Disease

Background: Despite the availability of effective lipid-lowering therapies (LLTs), most patients (pts) with ASCVD do not meet guideline-recommended LDL-C goals. In VICTORION-INITIATE (NCT04929249), an “inclisiran first” (IF) strategy of adding inclisiran immediately on failure to achieve LDL-C &lt;70 mg/dL, despite maximally tolerated statin therapy, in pts with ASCVD led to significantly higher LDL-C goal attainment vs usual care (UC) at Day 330. Objective: To evaluate change from baseline to Day 330 in pt-reported treatment satisfaction with an IF implementation strategy vs UC in pts with ASCVD enrolled in VICTORION-INITIATE. Methods: VICTORION-INITIATE, a Phase 3b, open-label, prospective trial, was conducted at 45 representative clinical sites across 20 US states. Pts randomized 1:1 (stratified by insurance status) received inclisiran 284 mg (300 mg inclisiran sodium) at Days 0, 90, and 270 plus UC or UC alone (lipid management directed by treating physicians). We evaluated change from baseline to Day 330 in pt-reported satisfaction with IF vs UC using the validated 11-question Treatment Satisfaction Questionnaire for Medication (TSQM)-II comprising 4 domains (effectiveness, side effects, convenience, and global satisfaction) scored from 0–100. As a post-hoc analysis of a pre-specified exploratory endpoint, we analyzed the difference in least-squares (LS) mean change in TSQM-II domain scores for IF vs UC using ANCOVA with baseline scores as a covariate. Results: We randomized 450 patients: median age 67 years, 30.9% female, 25.8% with a history of statin intolerance. From baseline to Day 330, difference in LS mean change (95% confidence interval) in TSQM-II scores for IF (n=139) vs UC (n=105) was significant (p&lt;0.001) for effectiveness (10.4 [5.4, 15.5]), convenience (10.5 [5.8, 15.2]), and global satisfaction (12.1 [7.2, 16.9]). Statistical comparison was not applicable for the side effects domain at Day 330 due to the small sample size (IF: n=6, UC: n=7). On Day 330, mean scores for IF exceeded UC for each TSQM-II question (Figure). Conclusions: An IF implementation strategy resulted in significantly greater change from baseline to Day 330 across multiple domains of pt-reported treatment satisfaction vs UC.

TEC-ADHERE: Real-World Persistence and Adherence on Dimethyl Fumarate in Patients with Relapsing-Remitting Multiple Sclerosis in the French OroSEP Patient-Support Program.

Treatment persistence and adherence are essential for achieving therapeutic goals in patients with multiple sclerosis (MS). OroSEP is an independent patient-support program (PSP) in France for patients with relapsing-remitting MS (RRMS) receiving oral disease-modifying therapies. TEC-ADHERE (NCT04221191; 08/19/2019-09/15/2022) was a prospective, non-interventional, phase4 study to assess the effect of OroSEP on persistence and adherence to dimethyl fumarate (DMF; Tecfidera™) in patients with RRMS. Outcomes were compared for patients in OroSEP versus non-OroSEP patients who received their neurologists' standard of care (SoC). Patients initiated DMF at month0 (M0); follow-up visits occurred at M3 and M6. Primary outcome was persistence at M6. Secondary outcomes included persistence at M1 and M3, adherence at M6 (Girerd questionnaire), anxiety (Generalized Anxiety Disorder Assessment), patient satisfaction at M6 (Treatment Satisfaction Questionnaire for Medication), patient and neurologist satisfaction with OroSEP participation, and adverse events (AEs). Per-protocol population included 341 patients (OroSEP, n = 135; SoC, n = 206). Persistence was similar for OroSEP vs SoC (M6, 75.9% vs 76.6%; M1, 96.0% vs 92.4%; M3, 85.5% vs 89.0%). At M6, mean adherence was higher for OroSEP (5.4) vs SoC (4.7; p < 0.0001), and good adherence (Girerd score = 6) was achieved by more OroSEP patients (55.7%) than SoC patients (29.6%; p < 0.01). Mean anxiety scores were lower in the OroSEP group than in the SoC group at baseline (7.1 vs 8.8; p = 0.02) and M6 (3.4 vs 6.1; p < 0.001). Mean satisfaction scores at M6 were higher for OroSEP (77.4) vs SoC (64.2; p < 0.01). Most neurologists (n = 11/14) agreed that OroSEP helped improve adherence. Treatment-related AEs occurred in 62 (36.3%) OroSEP patients and 76 (42.9%) SoC patients; most common were flushing, diarrhea, hot flush, and abdominal pain. These outcomes support the value of PSPs in encouraging adherence, alleviating anxiety, improving patient satisfaction, and supporting patients to be more independent in managing MS. ClinicalTrials.gov identifier, NCT04221191.

Curalin supplement as add-on therapy for type 2 diabetes Mellitus

AimsTo examine the efficacy and safety of Curalin, as a supplement to anti-diabetic drugs (ADD). Methods135 patients were enrolled in the study. Among them, 109, ages 18–85 years, with HA1c 7.5–10 % under treatment with ADD were randomized 1:1 to receive Curalin supplement or placebo. The primary efficacy endpoint was the change in HbA1c after 3 months. The secondary endpoint was a decrease in HbA1c by more than 0.5 % and by more than 1 %. The exploratory endpoints included the Diabetes Treatment Satisfaction Questionnaire (DTSQ), clinical and laboratory results. ResultsAfter 3 months, the mean reduction in HbA1c was 1.30 % (SD = 0.79) in the Curalin group compared to 0.10 % (SD = 0.70) in the placebo group (P < 0.0001). A decrease in HbA1c of ≥ 0.5 % was observed in 90.0 % of Curalin patients versus 19.0 % of placebo patients (P < 0.0001). HbA1c reduction of ≥ 1 % occurred in 64.0 % of Curalin patients and 11.9 % of placebo patients (P < 0.0001). Curalin patients reported higher satisfaction (DTSQ) with no severe adverse events. ConclusionsCuralin treatment significantly reduced HbA1c over a period of 3 months and was well-tolerated.

Treatment satisfaction and effectiveness of Lurasidone on quality of life and functioning in adult patients with schizophrenia in the real-world Italian clinical practice: a prospective 3-month observational study.

Although second-generation antipsychotics (SGAs) have proven to be effective therapeutic options for patients with schizophrenia, there is a notable lack of evidence on patients' subjective perspectives regarding their well-being, quality of life, and satisfaction with these medications. This study aimed to evaluate the treatment satisfaction and effectiveness of lurasidone on quality of life and functioning in adult patients with schizophrenia in real-world Italian clinical practice. This was a multicentre, national, non-interventional, single-arm, 3-month prospective study. Patients who were naive to lurasidone treatment and whose treating physician had decided to start them on this medication were enrolled and evaluated over a 3-month period. Eligible patients were adults (≥ 18 years of age) with a primary diagnosis of schizophrenia who were being treated with lurasidone (for the first time [i.e., they were lurasidone naive]) as part of routine clinical practice. Efficacy endpoints were changes in patient/caregiver treatment satisfaction (seven-point Likert scale from the Treatment Satisfaction Questionnaire for Medication), patient quality of life and functioning (QLS), investigator-rated global assessment of functioning (CGI-S, IAQ) after 6 weeks and 3 months of lurasidone, and number of relapses and hospitalizations. Sixty-one patients were enrolled and 59 completed the study. The median dosage of lurasidone at baseline was 37.00mg/day. The median duration of titration was 86.0 days (Min 28; Max 115 days); the median number of dosage changes was 1.0. At the end of 3-month observation period, the median dose of lurasidone was 74.00mg/day. QoL and Functioning Score showed a trend of improvement over time, reaching a mean change from baseline of 9.8 at the end of the study. According to the CGI-S, the percentage of patients who were "markedly or severely ill" showed a continuous decrease from baseline to 3 months, from 62.29% to 8.20%. Patient satisfaction increased over time, with 80.32% of patients reporting that they were somewhat, fairly, or very satisfied (including 63.93% who were completely or very satisfied) at the end of the study. No relapses/hospitalizations for psychiatric reasons were reported. Lurasidone was well tolerated with no safety concerns or discontinuations due to AEs. Lurasidone represents a valid option for the treatment of schizophrenia and positively affects subjective well-being, quality of life and satisfaction. NCT06527885 retrospectively registered (01/08/2024).

Therapeutic Effectiveness of SNOT 22-Based Interdose Interval Adjustment of Dupilumab for Chronic Rhinosinusitis With Nasal Polyps.

This study evaluates the enduring efficacy and patient satisfaction of dupilumab with interdose interval adjustments based on the Sino-Nasal Outcome Test (SNOT-22) in chronic rhinosinusitis with nasal polyps (CRSwNP). A retrospective analysis was conducted on 44 patients who had been treated with dupilumab for over 6 months. This study targeted individuals diagnosed with CRSwNP according to the 2020 edition of the European Position Paper on Rhinosinusitis and Nasal Polyps Criteria. The treatment involved an add-on dupilumab regimen, where the interdose interval was adjusted based on the SNOT-22 scores. Dosage adjustments were made such that patients with initial SNOT-22 scores greater than 40 were tapered to a target level of 20 or less. Similarly, for patients with initial scores of 40 or less, the treatment aimed for an improvement of 50% or more. At each visit, the effectiveness of the treatment was evaluated using SNOT-22, nasal polyp scores (NPS), and a subjective satisfaction questionnaire adapted from the Treatment Satisfaction Questionnaire for Medication (TSQM v.1.4). The adjustment of the interdose interval for dupilumab based on SNOT-22 scores demonstrated sustained improvements in patients' subjective symptoms, satisfaction, and NPS. The mean (standard deviation) SNOT-22 scores significantly decreased from 46.04 (22.30) to 14.72 (13.66) over 6 months (P<0.001). Similarly, NPS scores improved from 3.20 (2.24) to 1.72 (1.46) within the same period (P<0.001). Satisfaction scores, ranging from 0 to 5, consistently remained above 3.5 for up to 6 months (P=0.166). Additionally, there was a significant correlation between the improvement in the nasal symptom domain of the SNOT-22 scores and higher satisfaction scores. Adjusting dupilumab dosing intervals based on SNOT-22 scores from the outset resulted in sustained efficacy and patient satisfaction in Korean patients with CRSwNP. This approach will meaningfully assist clinicians in determining the optimal dupilumab dosing interval.

Effectiveness, safety, and patient-reported outcomes of emtricitabine/tenofovir alafenamide-based regimens for the treatment of HIV-1 infection: Final 24-month results from the prospective German TAFNES cohort study.

Tenofovir alafenamide (TAF) was introduced in the European Union in 2015 as a novel prodrug of tenofovir showing similar efficacy in clinical trials and a more favorable safety profile than tenofovir disoproxil fumarate (TDF). The German TAFNES cohort study (2016-2019) was conducted to generate real-world evidence. Treatment-naïve (TN) and treatment-experienced (TE) people with HIV (PWH) receiving elvitegravir/cobicistat/emtricitabine/TAF (E/C/F/TAF), rilpivirine/F/TAF (R/F/TAF) or F/TAF + 3rd agent were included. Month (M) 24 outcomes included virologic effectiveness (HIV RNA <50 copies/mL), treatment persistence, adverse drug reactions (ADRs) and patient-reported outcomes, using the HIV Symptom Index (HIV-SI), 36-Item Short Form Health Survey (SF-36) and HIV Treatment Satisfaction (HIVTSQ) questionnaires. The study included 767 PWH (92% men, median age 46 years; 301 TN, 466 TE; E/C/F/TAF [n = 318], R/F/TAF [n = 192], F/TAF + 3rd agent [n = 257]). Among TN, 35% had late HIV diagnosis (CD4 < 350/μL and/or AIDS). Of TE, 95% were on suppressive antiretroviral therapy (ART) before switching. D:A:D (Data Collection on Adverse Effects of Anti-HIV Drugs) 5-year risks for chronic kidney disease were high for about 1 in 10 TN and 4 in 10 TE. Overall treatment persistence at M24 was 81% (E/C/F/TAF: 88%; R/F/TAF: 86%; F/TAF + 3rd agent: 70%, with ART simplification of multiple-tablet regimens in 13%). M24 viral suppression (missing = excluded) was 96% (479/501). Discontinuations due to virologic failure or ADRs were rare, 2% (12/767) and 4% (30/767), respectively. HIV-SI and SF-36 summary scores improved in TN; HIVTSQ change scores showed an improvement in treatment satisfaction in TE. Real-world data confirmed a favorable safety profile and high virologic effectiveness with high treatment satisfaction on F/TAF-based ART.

Quality of life measures with etripamil self-administration for acute episodes of paroxysmal supraventricular tachycardia in a medically unsupervised setting: patient-reported outcomes from NODE-303

Abstract Background Etripamil nasal spray (NS) is a fast-acting, self-administered calcium-channel blocker in development for the conversion of AV-nodal dependent paroxysmal supraventricular tachycardia (PSVT) in a medically unsupervised setting. Prior studies show favorable safety and efficacy in converting single episodes of PSVT to sinus rhythm (SR). Purpose In NODE-303, patient-reported outcome (PRO) instruments assessed quality of life (QoL) over multiple etripamil-treated episodes of PSVT. Methods NODE-303 was an event-driven, multi-center, open-label Phase 3 study in North and South American patients with documented PSVT that evaluated the safety and efficacy of etripamil in PSVT termination, over multiple episodes and without the need for prior test dosing. Enrolled patients who perceived PSVT symptoms applied an ambulatory ECG cardiac monitoring system (CMS), performed a pre-trained vagal maneuver and, if symptoms persisted, self-administered etripamil NS 70 mg. A study amendment allowed a repeat dose (etripamil NS, 70 mg) if symptoms persisted 10 min after the first dose. Each patient could self-treat up to 4 episodes. Safety was assessed through adverse events, clinical data, and ECG CMS recordings. The Treatment Satisfaction Questionnaire for Medication (TSQM; validated for acute episodic assessments) and other PROs were administered, and healthcare utilization data were acquired. Patients completed PROs at baseline (BL), monthly, and per PSVT episode, which collected information on symptoms, episode characteristics, rescue medications, and emergency room visits. Additional PROs were the Brief Illness Perception Questionnaire (BIPQ), Cardiac Anxiety Questionnaire (CAQ), and 36-Item Short Form Health Survey (SF-36). Results There were higher proportions of patients reporting mild, minimal or no disease severity, every 6 months, than at BL; extremely severe, severe, and moderate disease severity was reported by smaller proportions of patients than at BL, though incomplete surveys at later visits may limit this analysis. Anxiety and stress about future PSVT episodes were consistently reduced from BL. Measures of treatment satisfaction, effectiveness, and convenience were consistent across multiple episodes, and were at levels considered favorable for the TSQM instrument (Table 1). Rates of emergency-room visits and hospital admissions across multiple, treated PSVT episodes were similar to those observed in trials assessing single episodes (Table 2). The BIPQ, CAQ or SF-36 had no notable changes from BL. Conclusions Etripamil self-administration was associated with patient-reported improvements in degree of disease severity, decreased anxiety and stress over future PSVT episodes, and levels of treatment satisfaction, effectiveness, and convenience considered favorable for respective PRO instrument. Using a symptom-prompted, self-administered treatment for PSVT could potentially improve QoL measures and reduce healthcare resource utilization.

Improvements in Patient-Reported Outcomes After 12 Months of Maintenance Therapy With Cabotegravir + Rilpivirine Long-Acting Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide in the Phase 3b SOLAR Study

SOLAR (NCT04542070; registered 2020–09-09) is a Phase 3b study that demonstrated the noninferior virological efficacy of switching to cabotegravir + rilpivirine long-acting (CAB + RPV LA) dosed every 2 months vs. continuing daily oral bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) over 12 months. Participants were randomised (2:1) to switch to CAB + RPV LA or to continue BIC/FTC/TAF. Patient-reported endpoints included treatment preference, treatment satisfaction (12-item HIV Treatment Satisfaction Questionnaire status version), acceptability of injections (Perception of Injection questionnaire [acceptability domain]) and three single-item questions exploring psychological challenges related to HIV treatment (fear of disclosure, adherence-related anxiety and reminder of HIV status). Of 670 participants, 447 participants switched to CAB + RPV LA and 223 continued BIC/FTC/TAF. Overall, 18% were female, median age was 37 years and 31% were non-White. At Month 12, CAB + RPV LA significantly improved treatment satisfaction vs. BIC/FTC/TAF (mean [95% confidence interval (CI)] change: + 3.36 [2.59, 4.13] vs. −1.59 [−2.71, −0.47]; p < 0.001). At Month 12, a higher proportion of CAB + RPV LA arm participants reported improvements across the psychological challenges related to HIV treatment questions compared with BIC/FTC/TAF participants. Participants indicating ≥ 1 psychological challenge at baseline experienced a statistically significant and clinically meaningful improvement in treatment satisfaction after 12 months of CAB + RPV LA vs. continuing BIC/FTC/TAF (adjusted difference [95% CI]: 7.96 [5.65, 10.26]; p < 0.001). Most (90%, 382/425) questionnaire respondents preferred CAB + RPV LA vs. BIC/FTC/TAF (5%, 21/425). Switching to CAB + RPV LA was associated with significantly improved treatment satisfaction and relief from the fear of disclosure, anxiety surrounding adherence and reminder of HIV status.