RICARDO ROMITI
Projetos de Pesquisa
Unidades Organizacionais
Instituto Central, Hospital das Clínicas, Faculdade de Medicina
LIM/53 - Laboratório de Micologia, Hospital das Clínicas, Faculdade de Medicina
LIM/50 - Laboratório de Patologia das Moléstias Infecciosas, Hospital das Clínicas, Faculdade de Medicina
LIM/53 - Laboratório de Micologia, Hospital das Clínicas, Faculdade de Medicina
LIM/50 - Laboratório de Patologia das Moléstias Infecciosas, Hospital das Clínicas, Faculdade de Medicina
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conferenceObject Patient perception and the importance of clear/almost clear skin as a treatment goal in moderate-to-severe plaque psoriasis: results of the 'Clear about Psoriasis' worldwide patient survey(2017) ARMSTRONG, A.; JARVIS, S.; BOEHNCKE, W-H; RAJAGOPALAN, M.; FERNANDEZ-PENAS, P.; ROMITI, R.; BEWLEY, A.; O'DONNELL, M.; HUNEAULT, L.; DEKKER, E.; SODHA, M.; WARREN, R. B.- Tofacitinib withdrawal and retreatment in moderate-to-severe chronic plaque psoriasis: a randomized controlled trial(2015) BISSONNETTE, R.; IVERSEN, L.; SOFEN, H.; GRIFFITHS, C. E. M.; FOLEY, P.; ROMITI, R.; BACHINSKY, M.; ROTTINGHAUS, S. T.; TAN, H.; PROULX, J.; VALDEZ, H.; GUPTA, P.; MALLBRIS, L.; WOLK, R.Background Tofacitinib is an oral Janus kinase inhibitor being investigated for the treatment of moderate-to-severe plaque psoriasis. Objectives To compare outcomes following tofacitinib withdrawal with outcomes of continuation. Methods In this phase 3 study (NCT01186744), patients received tofacitinib 5 mg (n = 331) or 10 mg (n = 335) twice daily for 24 weeks. The patients who achieved both >= 75% reduction in Psoriasis Area and Severity Index (PASI 75) score from baseline and Physician's Global Assessment (PGA) of 'clear' or 'almost clear' (PGA response) received a placebo (withdrawal) or the previous dose. At relapse (> 50% reduction in the PASI improvement during initial treatment) or week 40, the patients received the initial dose. Results Initial treatment: 33.5% and 55.2% achieved both PASI 75 and PGA responses with tofacitinib 5 and 10 mg twice daily, respectively, making them eligible for the treatment-withdrawal period. Withdrawal: 56.2%, 62.3%, 23.3% and 26.1% maintained PASI 75 responses with tofacitinib 5, 10 mg, placebo (5 mg) and placebo (10 mg) twice daily, respectively; 49.9%, 63.9%, 22.9% and 18.0% maintained PGA responses; and 92.3%, 93.0%, 32.8% and 42.9% did not relapse. Elevations in low-density lipoprotein-cholesterol levels following initial treatment (mean increase: 8.71 mg dL(-1) with 5 mg twice daily, 10.26 mg dL(-1) with 10 mg twice daily) were reversed upon withdrawal. Retreatment: 36.8% and 61.0% of patients who relapsed achieved PASI 75 responses with tofacitinib 5 or 10 mg after 16 weeks; 44.8% and 57.1% regained PGA responses. Conclusions Patients who received continuous treatment maintained a response more effectively when compared with placebo recipients. Safety profiles were comparable in both the continuous treatment group and retreatment group. Of those patients who relapsed, up to 60% recaptured a response with tofacitinib.
- Patient-dermatologist agreement in psoriasis severity, symptoms and satisfaction: results from a real-world multinational survey(2018) GRIFFITHS, C. E. M.; AUGUSTIN, M.; NALDI, L.; ROMITI, R.; GUEVARA-SANGINES, E.; HOWE, T.; PIETRI, G.; GILLOTEAU, I.; RICHARDSON, C.; TIAN, H.; JO, S. J.BackgroundPsoriasis is a chronic immune-mediated inflammatory disease, which often requires lifelong treatment. A strong partnership between the patient and healthcare practitioners should help to achieve effective treatment outcomes. ObjectiveTo assess concordance of views between patients with psoriasis and their treating dermatologists relative to psoriasis severity, presence of symptoms and satisfaction with disease control achieved. MethodsWe used data from the Growth from Knowledge (GfK) Disease Atlas real-world evidence program, a syndicated, retrospective, cross-sectional survey among dermatologists and their systemic therapy eligible patients with psoriasis, conducted across nine countries. Concordance was measured through patients and their dermatologist's identical answers to the same survey questions. Concordance was evaluated using percentage agreement between dermatologists and their patients, and Cohen's kappa () statistic. The level of concordance was defined as none' ( 0), none to slight' (0.01-0.20), fair' (0.21-0.40), moderate' (0.41-0.60), substantial' (0.61-0.80) and almost perfect' (>0.8). The analysis was conducted for the overall population and for each participating country. ResultsOverall, 524 dermatologists and 3821 patients with psoriasis were included in the survey. Concordance of patient and dermatologist perceptions of psoriasis severity was fair both at diagnosis, and at the time of the survey (61% agreement, = 0.326 and 55% agreement, = 0.370, respectively). Higher levels of concordance were reported when patients assessed their psoriasis as moderate-to-severe (using Investigator's Global Assessment/Physician's Global Assessment [IGA/PGA] 5-point scale of 3 or 4). Concordance regarding symptoms ranged from fair to moderate ( = 0.241-0.575). Satisfaction with psoriasis control was fair (39% agreement, = 0.213). Results showed different patterns of concordance across the participating countries although a low concordance was observed on the satisfaction with psoriasis control in all of them. ConclusionResults from this multinational real-world survey indicate different perceptions between patients with psoriasis and their dermatologist with respect to psoriasis severity, symptoms and disease control. Linked article: This article is commented on by P.V. Chernyshov, pp. 1404-1405 in this issue. To view this article visit
- Comorbidities in Chilean patients with psoriasis: a Global Healthcare Study on Psoriasis(2022) VALENZUELA, Fernando; CRUZ, Claudia De La; LECAROS, Cristobal; FERNANDEZ, Javier; HEVIA, Gonzalo; MAUL, Lara Valeska; THYSSEN, Jacob P.; VERA-KELLET, Cristian; EGEBERG, Alexander; ARMIJO, Daniela; PIZARRO, Cristian; RIVEROS, Tatiana; CORREA, Hernan; GUGLIELMETTI, Antonio; DIDASKALU, Johannes A.; WU, Jashin J.; GRIFFITHS, Christopher E. M.; ROMITI, Ricardo; MAUL, Julia-TatjanaBackground Psoriasis is a chronic inflammatory skin disease associated with several important medical comorbidities. There are scant data available on the comorbidities of patients with psoriasis in South America. Aim To examine the comorbidity profile of adult patients with psoriasis in Chile and its association with severity of psoriasis. Methods This was a multicentre, cross-sectional study involving 16 hospitals and clinics in Chile, which used a 48-item questionnaire to study clinician- and patient-reported outcomes and comorbidities. Inferential analyses were performed by psoriasis severity, using Fisher exact test, Student t-test and multivariable logistic regression. Results In total, 598 adult patients with psoriasis were included (51.1% male; mean age 49.2 +/- 15.1 years); 48.5% mild and 51.4% moderate to severe; Psoriasis Area and Severity Index 11.6 +/- 11.5; body surface area 14.7 +/- 18.2%. Plaque psoriasis was the most common phenotype (90.2%), followed by guttate (13.4%). Psoriatic arthritis occurred in 27.3% of patients. Comorbidities were reported in 60.2% of all patients with psoriasis. Frequent concomitant diseases were obesity (25.3%), hypertension (24.3%), Type 2 diabetes mellitus (T2DM) (18.7%), dyslipidaemia (17.4%), metabolic syndrome (16.7%) and depression (14.4%). After adjustment, significant associations were found between moderate to severe psoriasis and obesity, T2DM and nonalcoholic fatty liver disease (NAFLD) compared with mild psoriasis. Conclusions We report a large study of comorbidities, including depression, dyslipidaemia, T2DM and NAFLD, in people with psoriasis in Chile. The prevalence of comorbidities with psoriasis in Chile appears similar to that found in Western countries, and emphasizes the importance of assessing patients with psoriasis for risk factors for and presence of, comorbid disease in a multidisciplinary setting.
- Prevalence of psoriasis and other autoimmune skin diseases in a recently contacted indigenous community in the Auaris region, Yanomami Indigenous Territory, Brazil(2023) ROMITI, Ricardo; MARTINS, Luciana P. F.; SANTANA, Yago R. T.; TIMBO, Renata V.; KURIZKY, Patricia S.; BARROSO, Daniel H.; ANDRADE, Rafael R. De; GOMES, Ciro M.; GRIFFITHS, Christopher E. M.
conferenceObject PSORIATIC ARTHRITIS IS ASSOCIATED WITH A GREATER ECONOMIC AND HUMANISTIC BURDEN AMONG PATIENTS WITH PSORIASIS: RESULTS FROM A MULTINATIONAL PHYSICIAN AND PATIENT SURVEY(2016) ROMITI, R.; GRIFFITHS, C. E.; JO, S. J.; GUEVARA-SANGINES, E.; ROSE, A.; GILLOTEAU, I; FOX, T.; RICHARDSON, C.; TIAN, H.; NALDI, L.; AUGUSTIN, M.conferenceObject Greater burden of disease in systemic eligible psoriasis patients with anxiety and/or depression: Results from a large observational physician and patient survey(2017) NALDI, Luigi; GRIFFITHS, Christopher; JO, Seong-Jin; GUEVARA-SANGINES, Esther; ROMITI, Ricardo; HOWE, Tanya; RICHARDSON, Craig; TIAN, Haijun; AUGUSTIN, Matthias- Biosimilars for psoriasis: worldwide overview of regulatory guidelines, uptake and implications for dermatology clinical practice(2017) COHEN, A. D.; WU, J. J.; PUIG, L.; CHIMENTI, S.; VENDER, R.; RAJAGOPALAN, M.; ROMITI, R.; CRUZ, C. de la; SKOV, L.; ZACHARIAE, C.; YOUNG, H. S.; FOLEY, P.; WALT, J. M. van der; NALDI, L.; PRENS, E. P.; BLAUVELT, A.The introduction of biological drugs for the treatment of patients with psoriasis has revolutionized treatment paradigms and enabled numerous patients to achieve disease control with an acceptable safety profile. However, the high cost of biologics limits access to these medications for the majority of patients worldwide. In recent years, the introduction of biosimilars for inflammatory diseases has become a fast evolving field. The future use of biosimilars offers the potential for decreased cost and increased access to biologics for patients with psoriasis. For approval of biosimilars, different regulatory agencies use highly variable methods for definition, production, approval, marketing and postmarketing surveillance. Due to potential interchangeability between biologics and biosimilars, traceability and pharmacovigilance are required to collect accurate data about adverse events in patients with psoriasis; spontaneous reporting, registries and use of big data' should facilitate this process on a global basis. The current article describes biosimilar regulatory guidelines and examples of biosimilar uptake in clinical practice in several countries around the world. As it is apparent that biological therapy treatment decisions may become more physician independent, the International Psoriasis Council recommends that dermatologists should take an active role in the development of biosimilar prescribing policies with their respective healthcare settings and government agencies. What's already known about this topic? The introduction of biosimilars for inflammatory diseases has become a fast evolving field. Development of biosimilars is anticipated to increase access to biological drugs and relieve part of the economic burden on health systems worldwide by providing lower-cost medications. What does this study add? The current article describes the uptake of biosimilars for patients with psoriasis in various countries. There are substantial differences in biosimilar regulatory strategies and market access for biosimilars around the world. The International Psoriasis Council advocates that dermatologists take an active role in the development of biosimilar prescribing policies worldwide. Linked Comment: Kirby. Br J Dermatol 2017; 177:1473.
conferenceObject PSORIASIS (PSO) PATIENTS' PROFILE AND IMPACT OF THE DISEASE ON PATIENTS' QUALITY OF LIFE AND WORK PRODUCTIVITY IN A REAL-LIFE SETTING IN BRAZIL(2017) LOPES, N.; PIETRI, G.; HOWE, T.; GILLOTEAU, I; TIAN, H.; PERTEL, P.; ROMITI, R.- Biosimilars for psoriasis: clinical studies to determine similarity(2017) BLAUVELT, A.; PUIG, L.; CHIMENTI, S.; VENDER, R.; RAJAGOPALAN, M.; ROMITI, R.; SKOV, L.; ZACHARIAE, C.; YOUNG, H.; PRENS, E.; COHEN, A.; WALT, J. van der; WU, J. J.Biosimilars are drugs that are similar, but not identical, to originator biologics. Preclinical analytical studies are required to show similarity on a molecular and structural level, but efficacy and safety studies in humans are essential to determining biosimilarity. In this review, written by members of the International Psoriasis Council, we discuss how biosimilars are evaluated in a clinical setting, with emphasis on extrapolation of indication, interchangeability and optimal clinical trial design.