Safety of dual biological therapy in Crohn’s disease: a case series of vedolizumab in combination with other biologics

Mao, Eric J.; Lewin, Sara; Terdiman, Jonathan P.; Beck, Kendall

doi:10.1136/bmjgast-2018-000243

Cited by 35 publications

(26 citation statements)

References 10 publications

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“…Previously, pooled data using small case series and case reports in inflammatory bowel disease patients treated with DBT included 10 Crohn's disease patients, with a majority having received vedolizumab and a TNF antagonist 20 . Although prior small case series had similar adverse event rates to this study, endoscopic data were generally lacking 18,19 . In contrast, this study significantly increase available data on this topic in patients with severe‐ and high‐risk Crohn's disease phenotypes.…”

Section: Discussionmentioning

confidence: 71%

“…Currently, natalizumab is rarely used due to the risk of progressive multifocal leukoencephalopathy and availability of safer and more selectively targeted anti‐integrin therapies such as vedolizumab 1 . Additional data on dual therapy with conventional biologics remain limited to case reports and series 17‐20 . Thus, a major knowledge gap exists on the safety and efficacy of combining contemporary biologic therapies in Crohn's disease.…”

Section: Introductionmentioning

confidence: 99%

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Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn’s disease

Yang

Panaccione

Whitmire

et al. 2020

Aliment Pharmacol Ther

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Background: Biologic therapies in patients with Crohn's disease often yield low clinical and endoscopic remission rates. After multiple failed therapies, combining two biologic therapies is possibly the sole medical alternative to recurrent surgery.However, data on this approach are limited. Aims:To assess the efficacy and safety of concomitant use of two biologic therapies in the largest cohort to date of refractory Crohn's disease patients. Methods: Data were extracted from Crohn's disease patients started on dual biologic therapy at two referral centres. Biologics utilised include infliximab, adalimumab, vedolizumab, ustekinumab, certolizumab and golimumab. The primary outcome was endoscopic improvement (>50% reduction in Simplified Endoscopic Score-Crohn's disease [SES-CD] or explicitly stated). Endoscopic remission (SES-CD < 3 or stated), clinical response (Crohn's disease-patient-reported outcome-2 score [PRO2] reduced by 8), clinical remission (PRO2 < 8), and C-reactive protein (CRP) were also assessed.Results: A total of 22 patients with 24 therapeutic trials of dual biologic therapy were identified. The majority of patients had prior surgical resections (91%), stricturing (59%) or penetrating (36%) phenotype, and perianal fistulas (50%). Median number of prior failed biologics was 4. Endoscopic improvement occurred in 43% of trials and 26% achieved endoscopic remission. Fifty per cent had clinical response and 41% achieved clinical remission. There were significant post-treatment reductions in median ] to 6.0 [2.5-8.0], P = 0.0005], to 13.4 [4.6-21.8], P = 0.002] and .0] to 9.0 [4.0-14.0], P = 0.02).Presence of perianal fistulas decreased from 50% to 33%. Adverse events occurred in 13% of trials. Conclusion:Dual biologic therapy was associated with clinical, biomarker and endoscopic improvements in selected patients with refractory Crohn's disease who failed multiple biologics. Further studies are needed to validate this approach.

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Section: Discussionmentioning

confidence: 71%

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn’s disease

Yang

Panaccione

Whitmire

et al. 2020

Aliment Pharmacol Ther

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“…One UC patient experienced dyspnea 5 months after starting combination treatment, but clinical examination, spirometry, and pulmonary highresolution computed tomography revealed no pathology. The symptoms resolved without any treatment.Finally, Mao et al[8] presented two additional cases of patients with CD treated with golimumab and vedolizumab.The first case was about a young man with stricturing ileocolonic and perianal CD,previously treated with azathioprine, infliximab, adalimumab, certolizumab, ustekinumab. At the age of 23 he required a second resection with end-ileostomy.…”

mentioning

confidence: 99%

Dual biological therapy with anti-TNF, vedolizumab or ustekinumab in inflammatory bowel disease: a systematic review with pool analysis

Ribaldone

Pellicano

Vernero

et al. 2019

Scandinavian Journal of Gastroenterology

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Background: Inflammatory bowel diseases patients eligible for biological therapy represent a group with considerable disease burden and biologics only achieve 40% clinical remission rates in responders after 1 year of therapy. Aims: To collect all the published data about patients treated with dual biological therapy with an Anti-TNF, vedolizumab or ustekinumab, for a period of at least 3 months and to pool the data about the effectiveness and safety. Methods: A MEDLINE, and Web of Science search of all studies published in English until January 1, 2019 was conducted. Results: We included 7 studies with a total of 18 patients. Fifteen patients were treated with a combination of an anti-TNF and vedolizumab, 3 patients were treated with vedolizumab and ustekinumab. Fifty-six percent of patients were affected by Crohn's disease and 50% of patients were treated with an immunosuppressant drug or steroid too. A clinical improvement was obtained in 100% of patients, and an endoscopic improvement in 93% of patients. No serious adverse events were reported. Conclusions: The use of dual biological therapy is an attractive therapeutic option and may be an opportunity to better tailor and personalize the therapies for patients. Further studies, as randomized control trials, to provide comparative efficacy and safety endpoints of combination therapies, and to clarify potential advantages of combined biological therapies, are needed.

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“…While there are case reports of dual biologic therapy potentially causing adverse events, there have also been cases reported where dual biologic therapy was well tolerated and significantly helped patients’ symptoms. 4 -7…”

Section: Discussionmentioning

confidence: 99%

A Review of Drug-Drug Interactions for Biologic Drugs Used in the Treatment of Psoriasis

Armanious

Vender

2020

J Cutan Med Surg

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Biologic drugs are increasingly being prescribed for the treatment of psoriasis. Very little information is available in the literature regarding potential drug interactions with these medications. This paper serves as a guide for prescribers to be aware of possible interactions between biologic drugs approved for the treatment of psoriasis in North America and concomitant therapies. Objective To provide an overview of reported drug interactions between biologic drugs and concomitant therapies. Methods Reports of potential drug interactions were compiled through a search of Micromedex, drug monographs (Canadian, American, and European), as well as a PubMed search of each biologic drug with the term “drug interaction.” Conclusion Generally, caution should be exercised when multiple immunosuppressive therapies are prescribed due to increased risk of infection. However, this is more the result of a synergistic effect as opposed to a true drug interaction. There have been cases where multiple biologic therapies have been concomitantly used without adverse events, as their mechanisms involved different pathways. The sources used to compile this guide were often comprised of low levels of evidence, reinforcing the idea that further studies are required to better direct prescribers.

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Safety of dual biological therapy in Crohn’s disease: a case series of vedolizumab in combination with other biologics

Cited by 35 publications

References 10 publications

Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn’s disease

Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn’s disease

Dual biological therapy with anti-TNF, vedolizumab or ustekinumab in inflammatory bowel disease: a systematic review with pool analysis

A Review of Drug-Drug Interactions for Biologic Drugs Used in the Treatment of Psoriasis

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