Unmet Needs in the Management of Moderate-to-Severe Psoriasis in Spain: A Multidimensional Evaluation.

Psoriasis is a chronic, systemic inflammatory disease that affects the skin, with a high impact on patients' quality of life. The aim of this study was to identify and determine the relative importance of unmet needs in the management of moderate-to-severe psoriasis in Spain, from a multi-stakeholder perspective. A mixed method-approach was used to collect information, design a questionnaire and a discrete-choice exercise, and elicit the unmet needs through a multidisciplinary committee composed of 12 experts. A total of 65 unmet needs were identified and categorized into 4 areas: clinical, patient-related, decision-making process, and social. Decision-making process unmet needs were perceived as the most pressing ones, followed by social, clinical and patient-related. Individually, the need to incorporate outcomes that are important to the patients and to have treatments that achieve total clearance with a rapid onset of action and long-term persistence were the most important unmet needs.

Effectiveness on mild stress and mixed urinary incontinence and impact on Quality of Life of a phytotherapic product containing astragalus, thyme, lavender, hop, equisetum, red clover, cypress and agrimonia at titrated concentrations. Results from a monocentric study.

OBJECTIVES: To assess any beneficial effect on quality of life of a daily treatment with a phytotherapic product containing astragalus, thyme, lavender, hop, equisetum, red clover, cypress and agrimonia at titrated concentrations in a cohort of female patients complaining mild stress urinary incontinence (SUI) or mixed urinary incontinence (MUI). MATERIALS AND METHODS: 42 non-consecutive female out-patients with mild SUI or mild MUI were assessed with a clinical evaluation, International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and Patients' Perception of Intensity of Urgency Scale (PPIUS) at baseline the start of the study and after two months of therapy with the phytotherapic product. At the end of the therapy the patients also compiled Patient Global Impression of Improvement (PGI-I). RESULTS: After the completion of the study there was a trend towards better results in each item of ICIQ-SF, but without any statistical significance with an average score in ICIQ-SF-1 of 3.12 ± 0.981 versus 3.21 ± 0.914 (p = 0.556), in ICIQ-SF-2 of 3.69 ± 1.422 versus 3.79 ± 1.372 (p = 0.68) and in ICIQ-SF-3 of 5.95 ± 1.618 versus 6.14 ± 1.670 (p = 0.462). The average reduction of PPIUS was of 0.09 (1.26 ± 1.481 versus 1.357 ± 1.509, p = 0.705). There was a reduction of average consumption of pads/die from 1.69 ± 0.636 to 1.54 ± 0.543 (p = 0.101). In relation to the PGI score, 23/42 patients (54.7%) reported no changes after the completion of the therapy, 13/42 (30.9%) reported a slight improvement, 5/42 (11.9%) were much improved and 1/42 (2.3%) was slightly worsened. Only 2/42 (4.7%) patients discontinued the treatment before of the completion of the study. We did not observe any adverse effects during the period of the study. CONCLUSIONS: The phytotherapic product seems to cause a slight improvement of the symptoms in a good rate of patients. Moreover it has a low rate of withdrawal, due to the lack of adverse events.

The social value of a PASI 90 or PASI 100 response in patients with moderate-to-severe plaque psoriasis in Spain.

Introduction: Psoriasis is a chronic disease involving the skin, which significantly impacts the quality of life. Disease severity and treatment efficacy (i.e., response) are assessed through the Psoriasis Area and Severity Index (PASI). A PASI 75 response, i.e., an improvement of at least 75% with respect to the baseline PASI score, has traditionally been used as a therapeutic benchmark in clinical trials. Therapeutic advances have made PASI 90 or PASI 100 responses possible in most patients treated with some biologics. A greater response may generate social value beyond clinical outcomes that would benefit both patients and society. Methods: A 1-year economic model was applied to estimate the impact of having a PASI 75, PASI 90, or PASI 100 response in four areas of analysis (quality of life, activities of daily living, work productivity, and out-of-pocket expenditures) and the social value of having a PASI 90 or PASI 100 response in comparison with a PASI 75 response. A mixed-methods approach based on the scientific literature, a focus group with patient, and an advisory committee with psoriasis stakeholders was used. The model included three different scenarios: having a PASI 90 vs a PASI 75 response; a PASI 100 vs a PASI 90 response; and a PASI 100 vs a PASI 75 response. A sensitivity analysis was included. Results: The annual economic impact per patient with moderate-to-severe plaque psoriasis having a PASI 75 response was estimated at L 6,139, mainly related to labour productivity losses and quality of life reductions. Having a PASI 90 or a PASI 100 response would reduce this impact to €3,956 or €1,353, respectively. Accordingly, the social value of having a PASI 90 instead of a PASI 75 response was estimated at €2,183, and €4,786 with a PASI 100 response. Discussion: A PASI 90 or PASI 100 response would have a lower economic impact and a greater social value than a PASI 75 response for patients with moderate-to-severe plaque psoriasis.

Assessing the value contribution of bimekizumab for the treatment of moderate-to-severe psoriasis using a multidisciplinary reflective multi-criteria decision analysis.

BACKGROUND: Multi-criteria decision analysis (MCDA) was proposed to surmount arbitrary clinical decisions in the field of biological therapies for psoriatic patients. At the same time, MCDA may further highlight the potential of bimekizumab for the treatment of moderate-to-severe psoriasis, compared to placebo, adalimumab, ustekinumab, secukinumab, and even ixekizumab and risankizumab. RESEARCH DESIGN AND METHODS: The EVIDEM framework was adapted to reflect relevant criteria for the assessment. Estimated values were obtained by means of an additive linear model combining weights and scores assigned by a multidisciplinary committee of 12 experts. Consistency and replicability were evaluated through an alternative weighting method and a re-test. RESULTS: Bimekizumab was assessed by the committee as an intervention with a positive value contribution for the treatment of moderate-to-severe psoriasis in comparison to any of the alternatives. The drug provides a substantial therapeutical benefits and improves the health results reported by the patients, as it combines a higher level of clearance, rapidity, and persistence with a similar safety and tolerability profile. CONCLUSIONS: Under a methodology with increasing use in the health field, bimekizumab was evaluated as a drug with a high added value for the treatment of moderate-to-severe psoriasis when compared to six different alternatives.