Real-world treatment patterns and disease control over one year in patients with inflammatory bowel disease in Brazil.

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are inflammatory bowel diseases (IBDs) with a remission-relapsing presentation and symptomatic exacerbations that have detrimental impacts on patient quality of life and are associated with a high cost burden, especially in patients with moderate-to-severe disease. The Real-world Data of Moderate-to-Severe Inflammatory Bowel Disease in Brazil (RISE BR) study was a noninterventional study designed to evaluate disease control, treatment patterns, disease burden and health-related quality of life in patients with moderate-to-severe active IBD. We report findings from the prospective follow-up phase of the RISE BR study in patients with active UC or CD. AIM: To describe the 12-mo disease evolution and treatment patterns among patients with active moderate-to-severe IBD in Brazil. METHODS: This was a prospective, noninterventional study of adult patients with active Crohn's disease (CD: Harvey-Bradshaw Index ≥ 8, CD Activity Index ≥ 220), inadequate CD control (i.e., calprotectin > 200 µg/g or colonoscopy previous results), or active ulcerative colitis (UC: Partial Mayo score ≥ 5). Enrollment occurred in 14 centers from October 2016 to February 2017. The proportion of active IBD patients after 9-12 mo of follow-up, Kaplan-Meier estimates of the time to mild or no activity and a summary of treatment initiation, discontinuation and dose changes were examined. RESULTS: The study included 118 CD and 36 UC patients, with mean ± SD ages of 43.3 ± 12.6 and 44.9 ± 16.5 years, respectively. The most frequent drug classes at index were biologics for CD (62.7%) and 5-aminosalicylate derivates for UC patients (91.7%). During follow-up, 65.3% of CD and 86.1% of UC patients initiated a new treatment at least once. Discontinuations/dose changes occurred in 68.1% of CD patients [median 2.0 (IQR: 2-5)] and 94.3% of UC patients [median 4.0 (IQR: 3-7)]. On average, CD and UC patients had 4.4 ± 2.6 and 5.0 ± 3.3 outpatient visits, respectively. The median time to first mild or no activity was 319 (IQR: 239-358) d for CD and 320 (IQR: 288-358) d for UC patients. At 9-12 mo, 22.0% of CD and 20.0% of UC patients had active disease. CONCLUSION: Although a marked proportion of active IBD patients achieved disease control within one year, the considerable time to achieve this outcome represents an unmet medical need of the current standard of care in a Brazilian real-world setting.

Real-world disease activity and sociodemographic, clinical and treatment characteristics of moderate-to-severe inflammatory bowel disease in Brazil.

BACKGROUND: Understanding the treatment landscape of inflammatory bowel diseases (IBD) is essential for improving disease management and patient outcomes. Brazil is the largest Latin American country, and it presents socioeconomic and health care differences across its geographical regions. This country has the highest increase in IBD incidence and prevalence in Latin America, but information about the clinical and treatment characteristics of IBD is scarce. AIM: To describe the sociodemographic, clinical, and treatment characteristics of IBD outpatients in Brazil overall and in the Southeast, South and Northeast/Midwest regions. METHODS: Multicenter, cross-sectional study with a 3-year retrospective chart review component. Patients with moderate-to-severe Crohn's disease (CD) or ulcerative colitis (UC) were consecutively enrolled between October 2016 and February 2017. Active CD at enrollment was defined as a Harvey Bradshaw Index ≥ 8 or a CD Activity Index ≥ 220 or a calprotectin level > 200 µg/g or an active result based on colonoscopy suggestive of inadequate control during the previous year; active UC was defined as a partial Mayo score ≥ 5. Descriptive statistics were used to analyze all variables. RESULTS: In a total of 407 included patients, CD was more frequent than UC, both overall (264 CD/143 UC patients) and by region (CD:UC ratios of 2.1 in the Southeast, 1.6 in the South and 1.2 in the Northeast/Midwest). The majority of patients were female (54.2% of CD; 56.6% of UC), and the mean ages were 45.9 ± 13.8 years (CD) and 42.9 ± 13.0 years (UC). The median disease duration was 10.0 (range: 0.5-45) years for both IBD types. At enrollment, 44.7% [95% confidence interval (CI): 38.7-50.7] of CD patients and 25.2% (95%CI: 18.1-32.3) of UC patients presented with active disease. More than 95% of IBD patients were receiving treatment at enrollment; CD patients were commonly treated with biologics (71.6%) and immunosuppressors (67.4%), and UC patients were commonly treated with mesalazine [5-Aminosalicylic acid (5-ASA)] derivates (69.9%) and immunosuppressors (44.1%). More than 50% of the CD patients had ileocolonic disease, and 41.7% presented with stricturing disease. One-quarter of CD patients had undergone CD-related surgery in the past 3 years, and this proportion was lower in the Northeast/Midwest region (2.9%). CONCLUSION: In Brazil, there are regional variations in IBD management. CD outweighs UC in both frequency and disease activity. However, one-quarter of UC patients have active disease, and most are receiving 5-ASA treatment.

Quality of life, work productivity impairment and healthcare resources in inflammatory bowel diseases in Brazil.

BACKGROUND: Inflammatory bowel diseases (IBD) have been associated with a low quality of life (QoL) and a negative impact on work productivity compared to the general population. Information about disease control, patient-reported outcomes (PROs), treatment patterns and use of healthcare resources is relevant to optimizing IBD management. AIM: To describe QoL and work productivity and activity impairment (WPAI), treatment patterns and use of healthcare resources among IBD patients in Brazil. METHODS: A multicenter cross-sectional study included adult outpatients who were previously diagnosed with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC). At enrolment, active CD and UC were defined as having a Harvey Bradshaw Index ≥ 8 or a CD Activity Index ≥ 220 or calprotectin > 200 µg/g or previous colonoscopy results suggestive of inadequate control (per investigator criteria) and a 9-point partial Mayo score ≥ 5, respectively. The PRO assessment included the QoL questionnaires SF-36 and EQ-5D-5L, the Inflammatory Bowel Disease Questionnaire (IBDQ), and the WPAI questionnaire. Information about healthcare resources and treatment during the previous 3 years was collected from medical records. Chi-square, Fisher's exact and Student's t-/Mann-Whitney U tests were used to compare PROs, treatment patterns and the use of healthcare resources by disease activity (α = 0.05). RESULTS: Of the 407 patients in this study (CD/UC: 64.9%/35.1%, mean age 42.9/45.9 years, 54.2%/56.6% female, 38.3%/37.1% employed), 44.7%/25.2% presented moderate-to-severe CD/UC activity, respectively, at baseline. Expressed in median values for CD/UC, respectively, the SF-36 physical component was 46.6/44.7 and the mental component was 45.2/44.2, the EQ-visual analog scale score was 80.0/70.0, and the IBDQ overall score was 164.0/165.0. Moderate to severe activity, female gender, being unemployed, a lower educational level and lower income were associated with lower QoL (P < 0.05). Median work productivity impairment was 20% and 5% for CD and UC patients, respectively, and activity impairment was 30%, the latter being higher among patients with moderate to severe disease activity compared to patients with mild or no disease activity (75.0% vs 10.0%, P < 0.001). For CD/UC patients, respectively, 25.4%/2.8% had at least one surgery, 38.3%/19.6% were hospitalized, and 70.7%/77.6% changed IBD treatment at least once during the last 3 years. The most common treatments at baseline were biologics (75.3%) and immunosuppressants (70.9%) for CD patients and 5-ASA compounds (77.5%) for UC patients. CONCLUSION: Moderate to severe IBD activity, especially among CD patients, is associated with a substantial impact on QoL, work productivity impairment and an increased number of IBD surgeries and hospitalizations in Brazil.

Recommendations on the use of biosimilars by the Brazilian Society of Rheumatology, Brazilian Society of Dermatology, Brazilian Federation of Gastroenterology and Brazilian Study Group on Inflammatory Bowel Disease--Focus on clinical evaluation of monoclonal antibodies and fusion proteins used in the treatment of autoimmune diseases.

The Brazilian Societies of Rheumatology (SBR) and Dermatology (SBD), the Brazilian Federation of Gastroenterology (FBG) and the Brazilian Study Group on Inflammatory Bowel Disease (GEDIIB) gathered a group of their respective specialists on the topic of interest to discuss the most relevant issues regarding the clinical use of biosimilar medicines in Brazil. The main aim of that meeting was to prepare a document with recommendations to guide medical specialists and to help the national regulatory and policy-making agencies as concerns the authorization for marketing biosimilars used in autoimmune diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's disease, juvenile idiopathic arthritis and ulcerative colitis. In addition to considerations on the typical differences between innovator medicines and biosimilars, the specialists established a set of seven recommendations on regulatory advances related to clinical studies, indication extrapolation, nomenclature, interchangeability, automatic substitution and pharmacovigilance.

Retocolite ulcerativa não complicada / Ulcerative colitis not complicated

Retocolite ulcerativa inespecífica (RCU) e doença de Crohn (DC) são consideradas as principais doenças inflamatórias intestinais idiopáticas (DIIs). De etiologia ainda desconhecida, evoluem, clinicamente, por surtos recorrentes, intercalando episódios de atividade inflamatória, acompanhados de manifestações digestivas e extradigestivas, com períodos de remissão, ambos imprevisíveis...

Nonspecific ulcerative recolitis (NUC) and Chron's Disease (CD) are considered the mainly idiopathic inflammatory bowel disease (IBD). Etiology unknown, the nonspecific ulcerative recolitis has a clinical proceed, by recurrent outbreaks, episodes of intercalated inflammatory activity, following by digestive and extra digestive symptoms, with period of remission, both of them are unpredictable...

Doença de Crohn estenosante / Stuttering crohn's disease

As estenoses são uma das mais graves complicações da doença de Crohn (DC), por pressuporem indicação de ressecção cirúrgica de segmentos intestinais e, como consequência,um novo desenho anatômico do canal alimentar, na maioria das vezes com perda dos eu estado fisiológico, objetivo insistentemente perseguido pelo tratamento medicamentoso desse processo inflamatório. Surgem tanto primariamente em áreas doentes do intestino delgado ou cólon quanto em anastomoses de cirurgias prévias.

Diverticulose, doença diverticular e diverticulite / Diverticulosis, diverticulitis and diverticular disease

Os autores revisaram um dos assuntos mais relevantes dentro da Gastroenterologia: diverticulose cólica, doença diverticular, diverticulite e outras complicações relacionadas com os divertículos cólicos, como o sangramento diverticular. São apresentados, extensivamente, dados epidemiológicos, fatores de risco, quadro clínico e os métodos diagnósticos mais atuais relativos à doença diverticular, diverticulite e outras complicações. Nos últimos anos, a abordagem terapêutica, particularmente nos casos não complicados de doença diverticular, evoluiu consideravelmente com o uso de mesalazina e probióticos, assuntos que mereceram uma análise crítica por parte dos autores, no contexto dos novos itens fisiopatológicos.

Obstipação intestinal na mulher / Constipation in women

Constipação intestinal crônica é uma disfunção digestiva que acomete de 20.

Avaliaçäo da saturaçäo urinária em pacientes com doença inflamatória intestinal / Evaluation of urinary saturation in patients with inflamatory bowel disease

A doença inflamatória intestinal (DII), como a doença de Crohn (DC) e a retocolite ulcerativa (RCU), pode associar-se à litogênese devido a hiperoxalúria entérica. Na avaliaçao metabólica de 12 pacientes DII (6 DC e 6 RCU), sendo 3 com litíase recente, nao se observou alteraçao significante da média de excreçao de cálcio, ácido úrico e oxalato versus pacientes com litíase (LIT) sem DII. Hipocitratúria foi evidenciada em 6112 (5O por cento) e hiperuricosúria em 3/12 (25 por cento) dos pacientes. Estes dados sugerem que pacientes DII, mesmo sem apresentar hiperoxalúria, podem expor-se a maior risco de formaçao de cálculos, devido à hiperuricosúria e também à hipocitratúria, possivelmente decorrente do quadro diarréico crônico.

Consideraçöes sobre o comprometimento do intestino delgado na esquistossomose mansônica murina e humana (editorial) / Consideration on the compromising of small intestine by human and murine schistosomiasis mansoni (editorial)

O autor faz revisäo sobre as alteraçöes morfofuncionais provocadas pela esquistossomose mansônica no intestino delgado, em humanos e animais de experimentaçäo

Sindrome de ma-absorcao: diagnostico e tratamento / Malabsorption syndrome: diagnosis and treatment

O comportamento variado das manifestacoes clinicas e dosachados laboratoriais da sindrome disabsortiva, em decorrencia da multiplicidade de sistemas e orgaos comprometidos nas diferentes patologias, que ocasionam umaperda nutricional enterica, nao deve desencorajar o medico generalista, a pesquisa de alguns dados que poderao informa-lo da existencia real da disabsorcao e ate mesmo da doenca responsavel pelo seu aparecimento.