Adalimumab for Ulcerative Colitis: Results of a Brazilian Multicenter Observational Study

Zacharias, Patricia; Damião, Adérson Omar Mourão Cintra; Moraes, Antônio Bento Alves de; Teixeira, Fábio Vieira; Ludvig, Juliano Coelho; Nones, Rodrigo Bremer; Saad-Hossne, Rogério; Sassaki, Lígia Yukie; Silva, Rosemary Pereira Lino da; Facchin, Luiza; Olandoski, Márcia; Kotze, Paulo Gustavo

doi:10.1590/s0004-2803.201700000-51

Cited by 10 publications

(7 citation statements)

References 28 publications

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“…The results of the present study are in tune with the reported efficacy of these agents in the real-world scenario, where the proportion of responders after 52 weeks of exposure varies from 30 to 65% for ADA [ 7 – 10 , 13 , 17 , 18 ] and from 39 to 70% for IFX [ 11 , 19 – 22 ], respectively. The discrepancy in the performance of biologics between the real-world scenario and pivotal studies is usually attributable to the restriction of concomitant treatments that could favor a response and the required washout period between one drug and another in the design of randomized clinical trials.…”

Section: Discussionsupporting

confidence: 83%

“…In this scenario, there is lack of data on the efficacy and safety of anti-TNF agents in Brazilian patients in UC, as public and private access to these agents is relatively recent [ 13 ]. Therefore, the present study aimed to analyze rates of clinical and endoscopic remission comparatively, between ADA and IFX, in Brazilian UC patients, and evaluate possible factors associated with clinical and endoscopic remission after 1 year of treatment.…”

Section: Introductionmentioning

confidence: 99%

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Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)

Sassaki

Magro²,

Saad-Hossne³

et al. 2022

BMC Gastroenterol

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Background Anti-TNF therapy represented a landmark in medical treatment of ulcerative colitis (UC). There is lack of data on the efficacy and safety of these agents in Brazilian patients. The present study aimed to analyze rates of clinical and endoscopic remission comparatively, between adalimumab (ADA) and infliximab (IFX), in Brazilian patients with UC, and evaluate factors associated with clinical and endoscopic remission after 1 year of treatment. Methods A national retrospective multicenter study (24 centers) was performed including patients with UC treated with anti-TNF therapy. Outcomes as clinical response and remission, endoscopic remission and secondary loss of response were measured in different time points of the follow-up. Baseline predictive factors of clinical and endoscopic remission at week 52 were evaluated using logistic regression model. Indirect comparisons among groups (ADA and IFX) were performed using Student's t, Pearson χ2 or Fisher's exact test when appropriated, and Kaplan Meier analysis. Results Overall, 393 patients were included (ADA, n = 111; IFX, n = 282). The mean age was 41.86 ± 13.60 years, 61.58% were female, most patients had extensive colitis (62.40%) and 19.39% had previous exposure to a biological agent. Overall, clinical remission rate was 66.78%, 71.62% and 82.82% at weeks 8, 26 and 52, respectively. Remission rates were higher in the IFX group at weeks 26 (75.12% vs. 62.65%, p < 0.0001) and 52 (65.24% vs. 51.35%, p < 0.0001) when compared to ADA. According to Kaplan–Meier survival curve loss of response was less frequent in the Infliximab compared to Adalimumab group (p = 0.001). Overall, endoscopic remission was observed in 50% of patients at week 26 and in 65.98% at week 52, with no difference between the groups (p = 0.114). Colectomy was performed in 23 patients (5.99%). Age, non-prior exposure to biological therapy, use of IFX and endoscopic remission at week 26 were associated with clinical remission after 52 weeks. Variables associated with endoscopic remission were non-prior exposure to biological therapy, and clinical and endoscopic remission at week 26. Conclusions IFX was associated with higher rates of clinical remission after 1 year in comparison to ADA. Non-prior exposure to biological therapy and early response to anti-TNF treatment were associated with higher rates of clinical and endoscopic remission.

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Section: Discussionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)

Sassaki

Magro²,

Saad-Hossne³

et al. 2022

BMC Gastroenterol

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“…There are a few published observational cohort studies in UC setting with patients having been treated with adalimumab [21][22][23]. However, these hitherto studies report short-term treatment outcomes (within 12 months), and we could not find any study on adalimumab treatment having a 6-year follow up.…”

Section: Discussionmentioning

confidence: 81%

Assessment of Long-Term Efficacy and Safety of Adalimumab in Patients with Ulcerative Colitis: Results from a 6-Year Real-World Clinical Practice

Sugimoto

Ikeya

Kato

et al. 2018

Dig Dis

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Background: Although evidence for the short- to medium-term efficacy of adalimumab in ulcerative colitis (UC) patients is emerging, there are a limited number of reports on the long-term efficacy of adalimumab. This study was to understand baseline demographic features, which potentially could be risk factors for relapse or colectomy following induction of remission by adalimumab in UC patients. Additionally, factors affecting long-term outcomes were to be identified. Methods: Twenty-one patients with UC who had been treated with adalimumab were reviewed retrospectively. Comparative analyses were undertaken by factoring steroid withdrawal versus non-withdrawal, long-term remission versus relapse following remission, and requiring surgical intervention for UC versus surgery-free. Results: Adalimumab treatment was associated with steroid tapering in steroid-dependent cases in the long term. Of the 14 patients in whom clinical remission was achieved, the cumulative nonrelapse survival rate at 350 weeks was 43.8% and the cumulative nonoperative survival rate was 85.7%. Risk factors for surgery included intolerance to salicylates (p = 0.005) and past treatment with tacrolimus (p = 0.023). Conclusions: Adalimumab treatment was associated with long-term efficacy in patients with mild UC – patients achieved a high cumulative nonoperative survival rate over a long period of time, beyond 6 years.

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“…There are descriptions of the efficacy and safety of anti-TNF agents in Latin America (14)(15)(16) . However, to date, there is scarce data on the precise penetration and frequency of use of biological agents in the management of IBD in our continent.…”

Section: Introductionmentioning

confidence: 99%

Biological Therapy Penetration for Inflammatory Bowel Disease in Latin America: Current Status and Future Challenges

Quaresma

Coy

Damião

et al. 2019

Arq. Gastroenterol.

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BACKGROUND: The introduction of anti-TNF agents represented a landmark in the management of both Crohn’s disease (CD) and ulcerative colitis (UC), with improved efficacy and safety when compared with conventional treatment. However, significant challenges still exist in Latin America to facilitate the access of biological agents for physicians and patients. OBJECTIVE: The aim of this review was to summarize current evidence on penetration of biological agents for CD and UC in Latin America. METHODS: Data are derived from a previous complete systematic review that explored different characteristics of inflammatory bowel diseases (IBD) in Latin America. The studies fully included in this previous systematic review which contained detailed descriptions of the percentage of use of biological agents in different cohorts throughout Latin American and Caribbean countries were included, and descriptive findings were compiled, describing CD and UC penetration of these drugs in different patient cohorts from different countries. RESULTS: From the 61 studies included in the original systematic review, only 19 included data of the percentage of patients treated with biological agents. Anti-TNF use in CD varied from 1.51% in Mexico up to 46.9% in Colombia, with most of the studies describing anti-TNF use in approximately 20%-40% of CD patients. On the other side, the frequency of the use of biologics was clearly lower in UC, varying from 0% in 2009 to up 16.2% in 2018, according to two different Mexican studies. Only two studies described the penetration of anti-TNF agents in IBD overall: 13.4% in a Colombian and 37.93% in a Brazilian study. No studies described percentage of use of new biologic agents (vedolizumab and ustekinumab). CONCLUSION: Penetration of anti-TNF agents in Latin America is comparable to the rest of the world in CD, but lower in UC. With the increase in the incidence and prevalence of IBD, specific strategies to increase access to anti-TNF agents in UC and new biological agents overall are warranted.

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Adalimumab for Ulcerative Colitis: Results of a Brazilian Multicenter Observational Study

Cited by 10 publications

References 28 publications

Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)

Anti-TNF therapy for ulcerative colitis in Brazil: a comparative real-world national retrospective multicentric study from the Brazilian study group of IBD (GEDIIB)

Assessment of Long-Term Efficacy and Safety of Adalimumab in Patients with Ulcerative Colitis: Results from a 6-Year Real-World Clinical Practice

Biological Therapy Penetration for Inflammatory Bowel Disease in Latin America: Current Status and Future Challenges

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