ABSTRACT
This Clinical Practice Guideline on the systemic treatment of Psoriasis includes the recommendations elaborated by a panel of experts from the Latin American Psoriasis Society SOLAPSO, who assessed the quality of the available evidence using the GRADE system and the PICO process to guide the literature search. To answer each question, the experts discussed the results of randomized controlled trials, observational studies and metanalysis evaluating the interventions identified (non-biologics, biologics and phototherapy) in different populations of patients with moderate to severe plaque-psoriasis, which was summarized in Tables ad-hoc. The main end-points considered to assess efficacy were PASI 50, 75, 90 and 100, PGA 0-1 and significant improvement of health-related quality of life. Specific adverse events, either severe or leading to treatment interruption, were also evaluated. The 31 recommendations included in this CPG follow the structure proposed by GRADE: direction (for or against) and strength (strong or weak). The goal of this CPG is to improve the management of patients with psoriasis by recommending interventions of proved benefit and providing a reference standard for the treating physician. Adhering to the contents of this CPG does not guarantee therapeutic success. The final decision on the specific treatment is the responsibility of the physician based on the individual circumstances and considering the values, the preferences and the opinions of the patient or caregivers.
Subject(s)
Biological Products/therapeutic use , Dermatologic Agents/therapeutic use , Dermatology/standards , Phototherapy/standards , Psoriasis/therapy , Administration, Oral , Dermatology/methods , Humans , Injections, Subcutaneous , Latin America , Phototherapy/methods , Psoriasis/diagnosis , Severity of Illness Index , Societies, Medical/standardsABSTRACT
With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry develops biosimilars, drugs that are a version (copy) of the substance of the original biological medicine, with the aim of facilitating access to these treatments. These biosimilars are prepared according to the specific requirements of regulatory bodies in terms of quality, efficacy and safety, and must be shown they are comparable to the reference product. This paper reviews the international and national regulatory framework, the controversies surrounding biosimilars, and presents the position of a group of experts regarding the use of biosimilars.
Subject(s)
Biosimilar Pharmaceuticals/administration & dosage , Dermatologic Agents/administration & dosage , Legislation, Drug , Psoriasis/drug therapy , Argentina , Consensus , Humans , Societies, MedicalABSTRACT
Con la aparición de los tratamientos biológicos, se ha modificado la terapéutica de muchas enfermedades, en especial las reumatológicas, dermatológicas y oncológicas. Debido al alto costo de estos productos y el vencimiento de las patentes, la industria farmacológica desarrolla los biosimilares, fármacos que son una versión (copia) de la sustancia de un medicamento biológico original, y que pueden facilitar el acceso a estos tratamientos. Son elaborados de acuerdo a exigencias específicas de organismos reguladores en cuanto a calidad, eficacia y seguridad, y debe demostrarse que son comparables al medicamento de referencia. Este trabajo revisa las normativas regulatorias internacionales y nacionales, las controversias que rodean a los biosimilares y presenta la posición de un grupo de expertos con respecto al uso de biosimilares.
With the appearance of biological treatments, therapeutics has changed in many rheumatological, dermatological and oncological diseases. Due to the high cost of these biological medicaments and the expiration of patents, the pharmacological industry develops biosimilars, drugs that are a version (copy) of the substance of the original biological medicine, with the aim of facilitating access to these treatments. These biosimilars are prepared according to the specific requirements of regulatory bodies in terms of quality, efficacy and safety, and must be shown they are comparable to the reference product. This paper reviews the international and national regulatory framework, the controversies surrounding biosimilars, and presents the position of a group of experts regarding the use of biosimilars.
Subject(s)
Humans , Psoriasis/drug therapy , Dermatologic Agents/administration & dosage , Biosimilar Pharmaceuticals/administration & dosage , Legislation, Drug , Argentina , Societies, Medical , ConsensusABSTRACT
BACKGROUND: Self-medication and non-adherence to treatment are very common practice. This often implies bad results for the patients, as well as for the physicians. Several studies suggest that up to 30-40% of the population is non-adherent to treatments. This problem generates 5% of all hospitalizations, having caused about 45,000 deaths in 2007 in Argentina. MATERIALS AND METHODS: A 21-question survey was carried out among 176 patients with psoriasis in the Psoriasis Center at the Fernandez Hospital in Buenos Aires, Argentina. RESULTS: Seventy-seven percent of the patients were non-adherent to treatment, and 33% were self-medicated. The two groups combined accounted for 82% of the population studied. We found no significant differences among the variables studied in either the non-adherence or the combined group, although males comprised 67% and females 33% of the self-medicated group, and that difference was statistically significant (P<0.025). CONCLUSIONS: Self-care is a very complex behavior to be explained by a single cause, which clearly makes it a multifactorial problem. In our view, patient education, the physician-patient relationship, and availability of more effective therapeutic options would be significant factors in modifying a deep-rooted behavior pattern.
