Efficacy and Safety of Adalimumab in Ulcerative Colitis Refractory to Conventional Therapy in Routine Clinical Practice

Bálint, Anita; Farkas, Klaudia; Palatka, Károly; Lakner, Lilla; Miheller, Pál; Rácz, I; Hegede, Gábor; Vincze, Áron; Horváth, Gábor; Szabó, Andrea; Nagy, Ferenc; Szepes, Zoltán; Gábor, Z; Zsigmond, F; Zsóri, Ágnes; Juhász, Márk; Csontos, Á; Szűcs, Mónika; Bor, Renáta; Milassin, Ágnes; Rutka, Mariann; Molnár, Tamás

doi:10.1093/ecco-jcc/jjv169

Cited by 43 publications

(50 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Among those who remained in response (34.1%), 8.3% lost response at week 52. The drug was optimized in 17.8% of the cases (3) . In the Spanish study, dose optimization was observed in 37.5% of the cases, among which 14.3% did not respond even after ADA weekly intake (9) .…”

Section: Discussionmentioning

confidence: 99%

“…Ulcerative colitis (UC) is an inflammatory disease of the large bowel with variable degree of activity, extent and disease course (3) . Up to 15% of patients can present with severe disease at diagnosis (7,30) and in up to 28% it can progress proximally in 10 years (16,30) .…”

Section: Introductionmentioning

confidence: 99%

“…Up to 15% of patients can present with severe disease at diagnosis (7,30) and in up to 28% it can progress proximally in 10 years (16,30) . Most patients have a recurrent and remitting disease course with periodic flares, in which intravenous corticosteroids and eventually colectomy can be necessary (3,6) . Treatment with tumor necrosis factor (TNF) inhibitor agents can be used in moderate-to-severe UC, refractory to conventional treatment with aminosalicylates and immunomodulators and/or in steroid-dependent patients (4,17) .…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

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

Zacharias

Damião

Moraes

et al. 2017

Arq. Gastroenterol.

View full text Add to dashboard Cite

-Background -Adalimumab is a monoclonal antibody, tumor necrosis factor-alpha (TNFα) inhibitor that has efficacy for inducing and maintaining remission in moderate-to-severe ulcerative colitis. Real world studies with adalimumab in Latin American ulcerative colitis patients are scarce.Objective -To assess the clinical remission rates in induction and maintenance with adalimumab therapy in ulcerative colitis. Declared conflict of interest of all authors: Damião AOMC (Nestle, Janssen, Abbvie, Pfizer and Takeda), Moraes AC (Janssen, Abbvie, Takeda), Teixeira FV (Janssen, Abbvie, Ferring, Takeda, Pfizer), Ludvig JC (Janssen, Abbvie, Takeda), Nones RB (Abbvie, Takeda), Saad-Hossne R (Janssen, Abbvie), Sassaki LY (Janssen, Abbvie, Takeda), Kotze PG (Janssen, Abbvie, Ferring, Takeda, Pfizer The rate of colectomy in ULTRA II trial was less than 5%, without stratification regarding the previous use of another anti-TNF agent (8) . The drug was approved by Food and Drug Administration (FDA) and National Sanitary Surveillance Agency (ANVISA), in 2012 and 2014, respectively (14) . Despite the results of the clinical trials, there is a discrepancy between those and real world data in UC (15) , similar to what was observed in terms of efficacy of ADA in Crohn's disease (CD) (13) . Retrospective studies of case series tend to have higher effectiveness rates than randomized trials, which have a more strict analysis. Furthermore, it is enquired what the ideal dose of ADA in the management of UC would be needed (12) , showing the need of data from real life studies to better define the drug's role in treatment algorithms. There is scarce real world data on the use of ADA in UC reported in Brazil and Latin America, which motivated the present study (1,2,9,10,18,28,29) . The primary aim of this study was to analyze clinical remission rates in ADA induction and maintenance in UC treatment. Secondary objectives were to analyze clinical response, endoscopic remission, colectomy rates, adverse events, and secondary loss of response, besides dose optimization or drug switching during the follow-up period. Adalimumab for ulcerative colitis: results of a Brazilian multicenter observational study METHODS Study designThis was a longitudinal, analytical, observational and retrospective study of a case series of patients with moderate-to-severe UC under ADA therapy. All patients were treated in seven referral centers for inflammatory bowel disease (IBD) from south/southeast Brazil, and were analyzed from

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

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

Zacharias

Damião

Moraes

et al. 2017

Arq. Gastroenterol.

View full text Add to dashboard Cite

show abstract

“…21 Indeed, with increasing recognition of ulcerative colitis as a progressive disease rather than a disorder with periodic flares, 22 the threshold for introducing biologic drugs is steadily being lowered. 23 Few head to head comparisons of different anti-TNFs exist in this situation, although experience suggests that infliximab is preferable for treating active disease. [24][25][26][27][28][29] However, there is less of a consensus on when to introduce biologic agents in patients with Crohn's disease.…”

Section: Starting Anti-tnf Treatmentmentioning

confidence: 99%

Update on anti-tumor necrosis factor agents and other new drugs for inflammatory bowel disease

Cohen

Sachar

2017

BMJ

115

View full text Add to dashboard Cite

The treatment of inflammatory bowel disease (IBD)-ulcerative colitis (UC) and Crohn's disease (CD)-has evolved beyond surgery with the introduction of biologic agents, primarily antibodies against mediators of inflammation and cell attraction. Anti-tumor necrosis factor (TNF) agents have been the first line treatment for moderate to severe ulcerative colitis and Crohn's disease for more than 15 years. During that time much has been learnt about how best to use these agents. This review will assess the evidence on how to optimize the use of anti-TNF agents; when and how to start treatment; how to monitor treatment and when to de-escalate it; and the potential adverse effects of these drugs. New and emerging treatments such as anti-attractants, anti-interleukins, and Janus kinase (JAK) inhibitors will also be discussed.

show abstract

“…9 Indeed, perhaps driven by ulcerative colitis being considered more as a progressive disease rather than a disorder with periodic flares, 10 the threshold for introduction of biological therapy is being lowered. 11 NICE has approved the use of biological therapy for moderate ulcerative colitis since 2015 and acute severe ulcerative colitis since 2008. The 2015 NICE guidance (TA329) advocates that the choice of treatment between anti-TNF alpha therapies be made on an individual basis following discussion between the patient and clinician.…”

Section: Biological Drugs In Moderate To Severe Ulcerative Colitismentioning

confidence: 99%

Recommended drug therapies for inflammatory bowel disease

White¹,

Thakor²,

Goel³

2018

Prescriber

View full text Add to dashboard Cite

show abstract

Efficacy and Safety of Adalimumab in Ulcerative Colitis Refractory to Conventional Therapy in Routine Clinical Practice

Abstract: UC is a progressive disease that may need early aggressive therapy to prevent structural and functional complications. The results of our study demonstrated the favourable efficacy of short- and long-term ADA treatment for patients with UC.

Cited by 43 publications

References 12 publications

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

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

Update on anti-tumor necrosis factor agents and other new drugs for inflammatory bowel disease

Recommended drug therapies for inflammatory bowel disease

Contact Info

Product

Resources

About