Effectiveness of Adalimumab in Perianal Fistulas in Crohn’s Disease Patients Naive to Anti-TNF Therapy

Castaño-Milla, Carlos; Chaparro, María; Saro, Cristina; Acosta, Manuel Barreiro‐de; García‐Albert, Ana M.; Bujanda, Luís; Martín-Arranz, María Dolores; Carpio, Daniel; Muñoz, Fernándo; Manceñido, Noemí; García‐Planella, Esther; Piqueras, Marta; Calvet, Xavier; Cabriada, José Luis; Botella, Belén; Bermejo, Fernando; Gisbert, Javier P.

doi:10.1097/mcg.0000000000000169

Cited by 62 publications

(44 citation statements)

References 30 publications

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“…A subanalysis of the Crohn’s Trial of the Fully Human Antibody Adalimumab for Remission Maintenance study demonstrated the efficacy ADA in maintaining fistula healing in a significant proportion of patients up to 2 years after induction 29. A Spanish multicentre retrospective study also demonstrated the efficacy of ADA with remission rates in complex perianal fistulas (defined by absence of drainage after therapy) in CD of 41% at 6 months and 29% at 12 months 30. Another small prospective study with ADA suggested that its efficacy can be increased with the addition of ciprofloxacin in order to heal fistulas in CD 25.…”

Section: Conventional Non-biologic Medical Therapy Biologics and Permentioning

confidence: 97%

Modern management of perianal fistulas in Crohn’s disease: future directions

Kotze

Shen

Lightner

et al. 2018

Gut

135

104

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Perianal fistulae in patients with Crohn's disease (CD) can be associated with significant morbidity resulting in negative impact on quality of life. The last two decades have seen significant advancements in the management of perianal fistulas in CD, which has evolved into a multidisciplinary approach that includes gastroenterologists, colorectal surgeons, endoscopists and radiologists. Despite the introduction of new medical therapies such as antitumour necrosis factor and novel models of care delivery, the best fistula healing rates reported with combined medical and surgical approaches are approximately 50%. More recently, newer biologics, cell-based therapies as well as novel endoscopic and surgical techniques have been introduced raising new hopes that outcomes can be improved upon. In this review, we describe the modern management and the most recent advances in the management of complex perianal fistulising CD, which will likely impact clinical practice. We will explore optimal use of both older and newer biological agents, as well as new data on cell-based therapies. In addition, new techniques in endoscopic and surgical approaches will be discussed.

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Section: Conventional Non-biologic Medical Therapy Biologics and Permentioning

confidence: 97%

Modern management of perianal fistulas in Crohn’s disease: future directions

Kotze

Shen

Lightner

et al. 2018

Gut

135

104

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“…АДА является моноклональным антителом против α-ФНО, по своей структуре идентичным иммуноглобули-ну G 1 человека. В настоящее время большая часть инфор-мации из клинических исследований, метаанализов и не-контролируемых исследований демонстрирует эффектив-ность АДА в индуцировании и поддержании клиническо-го ответа и ремиссии заболевания [2,[5][6][7][8][9][10][11][12][13][14][15][16][17][18][19].…”

Section: Discussionunclassified

“…В ряде исследований получе-ны данные о полном закрытии дренирующих свищей у 33% против 13% пациентов, получавших лечение АДА 40 мг/2 нед и плацебо соответственно (p<0,05) [6]. В последу-ющих публикациях, в которых оценивалась эффектив-ность АДА при свищевой БК в рамках проспективных ис-следований [15] и ретроспективного анализа реальной клинической практики [16], также подтверждается эф-фективность препарата.…”

Section: Discussionunclassified

“…Мы обнаружили достижение полного от-вета на лечение в 69,6, 78,3 и 69,6% случаев на 1-м, 6-м месяце и в конце периода наблюдения соответственно. Эти результаты сопоставимы с данными других опубли-кованных ретроспективных оценок эффективности пре-парата [16]. Доля пациентов, достигших клинической ре-миссии на соответствующих временных промежутках оценки, значительно превышает таковую в рандомизиро-ванных плацебо-контролируемых исследованиях.…”

Section: Discussionunclassified

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Efficacy of adalimumab for Crohn’s disease in real clinical practice

Knyazev

Каграманова

Ручкина

et al. 2017

Terapevticheskii arkhiv

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Aim. To evaluate the efficacy and safety of adalimumab (ADA) in patients with Crohn’s disease (CD) treated at the Department of Inflammatory Bowel Diseases, Moscow Clinical Research and Practical Center, and to determine the predictors of a therapy response. Subjects and methods. All the patients with CD treated with ADA were followed up for at least 6 months or until the drug was discontinued. Therapeutic effectiveness was evaluated at 4 weeks and 6 months after the initiation of treatment and at the end of a follow-up. Complete intestinal mucosal healing was assessed at 3 and 12 months following treatment initiation. Univariate and multivariate analyses were used to determine the predictors of treatment response. Results. A clinical analysis covered 70 patients (57.1% male); the follow-up period averaged 112 weeks. Perianal fistulas were at baseline established in 22 (31.4%) patients with CD. 12 (17.4%) patients had been previously treated with infliximab (INF), 7 of them discontinued the drug for secondary loss of response and 5 for adverse reactions. 68 (97.1%) patients responded to an induction course of ADA. At 4 weeks, 6 months, and at the end of the follow-up, clinical remission occurred in 66.7, 80.4 and 67.4 % of patients with luminal CD and in 45.4, 36.5, and 36.4% of those with perianal CD, respectively. At 3 and 12 months and at the end of the follow-up, there was complete healing of the intestinal mucosa in 23.5, and 41.2 and 29.5% of cases, respectively. Six (8.8%) patients responding to the induction course needed to be optimized with ADA to 40 mg weekly. The time interval between treatment initiation and dose optimization averaged 30 weeks (range 12-120 months). There were 15 (21,4%) adverse events that were responsible for ADA discontinuation in 3 (4,2%) patients. Conclusion. The findings demonstrate the efficacy and safety of ADA used in clinical practice.

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“…The immunomodulators, azathioprine and 6-mercaptopurine, are considered a mainstay for sparing steroid use and for maintaining remission in CD [7,8,9]. The introduction of the monoclonal antibodies targeting tumor necrosis factor-alpha improved CD treatment, providing an effective therapeutic option for patients with refractory and fistulizing CD, lowering hospitalization and surgery rates and modifying disease course and outcomes [7,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24]. Furthermore, pivotal studies supported the benefit of a “top-down” strategy [15,19].…”

Section: Introductionmentioning

confidence: 99%

Comparative Study of Two Cohorts of Newly Diagnosed Crohn's Disease Demonstrates Change in Therapeutic Strategies

Icht

Yanai²,

Ron³

et al. 2017

Digestion

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Background: There has been a paradigm shift in the treatment of Crohn's disease (CD) involving the rapid introduction of biologics and/or immunomodulators after diagnosis. We wished to assess whether this was applied to patients with newly diagnosed CD in a tertiary inflammatory bowel disease referral centre in Israel. Methods: Newly diagnosed CD patients were stratified into 2 groups: the early group was diagnosed between 2005 and 2007 and the late group was diagnosed between 2010 and 2012. Baseline demographics, medical and surgical treatments, disease course and complications during those 2 periods were analyzed. Results: Each group included 60 patients. Significantly higher rates of immunomodulators and biologics were administered to patients in the late group compared to the early group (81.7 and 36.7% compared to 56.7 and 18.3%, p = 0.004 and p = 0.021, respectively). On the other hand, steroid therapy was less prevalent in the late (36.7%) group compared to that of the early group (56.7%), p = 0.059. Medical and surgical CD outcomes, including exacerbations/hospitalizations and surgeries, were comparable for both groups. Conclusions: There was a change in treatment strategy between 2005-2007 and 2010-2012, as reflected in higher proportions of biologics/immunomodulators for patients with newly diagnosed CD. This was associated with a steroid-sparing effect.

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Effectiveness of Adalimumab in Perianal Fistulas in Crohn’s Disease Patients Naive to Anti-TNF Therapy

Abstract: ADA was effective for the treatment of perianal fistulas in CD patients naive to anti-TNF drugs. We found a good correlation between clinical and radiologic assessment of therapy response.

Cited by 62 publications

References 30 publications

Modern management of perianal fistulas in Crohn’s disease: future directions

Modern management of perianal fistulas in Crohn’s disease: future directions

Efficacy of adalimumab for Crohn’s disease in real clinical practice

Comparative Study of Two Cohorts of Newly Diagnosed Crohn's Disease Demonstrates Change in Therapeutic Strategies

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