Co-treatment With Golimumab and Vedolizumab to Treat Severe UC and Associated Spondyloarthropathy

Co-treatment With Golimumab and Vedolizumab to Treat Severe UC and Associated Spondyloarthropathy Vedolizumab is efficacious for induction and maintenance of remission in ulcerative colitis [UC] patients.1 However, whether vedolizumab is effective for extra-intestinal manifestations remains to be determined. We report a UC patient with ankylosing spondylitis [AS], who received combined treatment with anti-tumour necrosis factor [TNF] and vedolizumab resulting in lasting remission. The patient was a 48-year-old female, who has had 4 years of E3-type UC and positive human leukocyte antigen B27 [HLAB27] and AS. Following failure of salazopyrin and methotrexate, she achieved clinical remission with infliximab and methotrexate combination. However, loss of response of UC later developed, with a total Mayo score of 10 and a Mayo endoscopic score of 3 despite quiescent AS. Adalimumab with methotrexate re-induced clinical and endoscopic remission of her UC, but the patient subsequently stopped therapy due to injection site pruritus, pain, and nausea. She remained well without treatment for 1 year, at which time UC symptoms recurred with Mayo endoscopic score of 3, still in the absence of axial symptoms. C-reactive protein [CRP] was 14 mg/L, albumin 41 g/L, and infection work-up including tissue cytomegalovirus polymerase chain reaction [CMV PCR] was negative. Vedolizumab was started at 300 mg at Weeks 0–2–6 and every 8 weeks thereafter, along with prednisone at 40 mg/day tapered completely by Week 6. The patient’s bloody diarrhoea resolved, and she had a total Mayo score of 2 with a sub-endoscopic score of 1 by Week 14. However, starting at Week 10, disabling symptoms of AS re-emerged with a Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] of 9 and an increase of CRP to 52 mg/L. After discussion with the rheumatologists and in agreement with the patient, subcutaneous [SC] golimumab was added to vedolizumab and administered at 200–100 mg at Weeks 0–2, respectively, and 50 mg every 4 weeks thereafter, which induced resolution of axial symptoms. After 1 year of combined vedolizumab-golimumab treatment, the patient is in clinical and endoscopic remission of UC with no clinical activity of SPA. No adverse effects nor infection events occurred throughout the 1 year of treatment. The association of UC and AS is not rare. In a population-based cohort, 4.5% had ankylosing spondylitis and 7.7% an axial spondyloarthritis.2 Vedolizumab is a humanised IgG1 monoclonal antibody to α4β7-integrin, which modulates gut lymphocyte trafficking, but whether it is effective for extra-intestinal IBD manifestations is still debated. Indeed, a series of five patients treated with vedolizumab, who promptly developed new-onset or exacerbation of sacroiliitis or arthritis, was reported.3 Combination of drugs may be possible strategy in some such patients, but experience with combination of biologics is limited. A decade ago, a placebo-controlled trial in Crohn’s disease patients with ongoing symptoms while receiving maintenance infliximab therapy, showed that addition of natalizumab to infliximab was safe and tended to improve symptom control.4 A recent small case-series reported in abstract form, described IBD patients treated with vedolizumab in combination with infliximab, without any apparent adverse events.5 The presently reported patient adds to this limited experience of combination biologic therapies in IBD. However, ascertainment of efficacy and safety of combination vedolizumab with anti-TNFs mandates randomised controlled trials, and one has already been launched [NCT02764762]. Funding None. Conflict of Interest None. Author Contributions All authors contributed equally to this letter. References 1. Sandborn WJ, Feagan BG, Rutgeerts Pet al.  ; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med  2013; 369: 711– 21. Google Scholar CrossRef Search ADS PubMed  2. Ossum AM, Palm Ø, Lunder AKet al.   Ankylosing spondylitis and axial spondyloarthritis in patients with long-term inflammatory bowel disease: Results from 20 years of follow-up in the IBSEN study. J Crohns Colitis  2017 Sep 13. doi: 10.1093/ecco-jcc/jjx126. [Epub ahead of print.] 3. Varkas G, Thevissen K, De Brabanter Get al.   An induction or flare of arthritis and/or sacroiliitis by vedolizumab in inflammatory bowel disease: a case series. Ann Rheum Dis  2017; 76: 878– 81. Google Scholar CrossRef Search ADS PubMed  4. Sands BE, Kozarek R, Spainhour Jet al.   Safety and tolerability of concurrent natalizumab treatment for patients with Crohn’s disease not in remission while receiving infliximab. Inflamm Bowel Dis  2007; 13: 2– 11. Google Scholar CrossRef Search ADS PubMed  5. Buer LHM, Medhus AW, Moum B. Combination treatment with vedolizumab 1043 and anti-TNF-α in inflammatory bowel disease: safety data. J Crohns Colitis  2017; submited. Copyright © 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Journal of Crohn's and Colitis Oxford University Press

Co-treatment With Golimumab and Vedolizumab to Treat Severe UC and Associated Spondyloarthropathy

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Publisher
Elsevier Science
Copyright
Copyright © 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com
ISSN
1873-9946
eISSN
1876-4479
D.O.I.
10.1093/ecco-jcc/jjx142
Publisher site
See Article on Publisher Site

Abstract

Vedolizumab is efficacious for induction and maintenance of remission in ulcerative colitis [UC] patients.1 However, whether vedolizumab is effective for extra-intestinal manifestations remains to be determined. We report a UC patient with ankylosing spondylitis [AS], who received combined treatment with anti-tumour necrosis factor [TNF] and vedolizumab resulting in lasting remission. The patient was a 48-year-old female, who has had 4 years of E3-type UC and positive human leukocyte antigen B27 [HLAB27] and AS. Following failure of salazopyrin and methotrexate, she achieved clinical remission with infliximab and methotrexate combination. However, loss of response of UC later developed, with a total Mayo score of 10 and a Mayo endoscopic score of 3 despite quiescent AS. Adalimumab with methotrexate re-induced clinical and endoscopic remission of her UC, but the patient subsequently stopped therapy due to injection site pruritus, pain, and nausea. She remained well without treatment for 1 year, at which time UC symptoms recurred with Mayo endoscopic score of 3, still in the absence of axial symptoms. C-reactive protein [CRP] was 14 mg/L, albumin 41 g/L, and infection work-up including tissue cytomegalovirus polymerase chain reaction [CMV PCR] was negative. Vedolizumab was started at 300 mg at Weeks 0–2–6 and every 8 weeks thereafter, along with prednisone at 40 mg/day tapered completely by Week 6. The patient’s bloody diarrhoea resolved, and she had a total Mayo score of 2 with a sub-endoscopic score of 1 by Week 14. However, starting at Week 10, disabling symptoms of AS re-emerged with a Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] of 9 and an increase of CRP to 52 mg/L. After discussion with the rheumatologists and in agreement with the patient, subcutaneous [SC] golimumab was added to vedolizumab and administered at 200–100 mg at Weeks 0–2, respectively, and 50 mg every 4 weeks thereafter, which induced resolution of axial symptoms. After 1 year of combined vedolizumab-golimumab treatment, the patient is in clinical and endoscopic remission of UC with no clinical activity of SPA. No adverse effects nor infection events occurred throughout the 1 year of treatment. The association of UC and AS is not rare. In a population-based cohort, 4.5% had ankylosing spondylitis and 7.7% an axial spondyloarthritis.2 Vedolizumab is a humanised IgG1 monoclonal antibody to α4β7-integrin, which modulates gut lymphocyte trafficking, but whether it is effective for extra-intestinal IBD manifestations is still debated. Indeed, a series of five patients treated with vedolizumab, who promptly developed new-onset or exacerbation of sacroiliitis or arthritis, was reported.3 Combination of drugs may be possible strategy in some such patients, but experience with combination of biologics is limited. A decade ago, a placebo-controlled trial in Crohn’s disease patients with ongoing symptoms while receiving maintenance infliximab therapy, showed that addition of natalizumab to infliximab was safe and tended to improve symptom control.4 A recent small case-series reported in abstract form, described IBD patients treated with vedolizumab in combination with infliximab, without any apparent adverse events.5 The presently reported patient adds to this limited experience of combination biologic therapies in IBD. However, ascertainment of efficacy and safety of combination vedolizumab with anti-TNFs mandates randomised controlled trials, and one has already been launched [NCT02764762]. Funding None. Conflict of Interest None. Author Contributions All authors contributed equally to this letter. References 1. Sandborn WJ, Feagan BG, Rutgeerts Pet al.  ; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med  2013; 369: 711– 21. Google Scholar CrossRef Search ADS PubMed  2. Ossum AM, Palm Ø, Lunder AKet al.   Ankylosing spondylitis and axial spondyloarthritis in patients with long-term inflammatory bowel disease: Results from 20 years of follow-up in the IBSEN study. J Crohns Colitis  2017 Sep 13. doi: 10.1093/ecco-jcc/jjx126. [Epub ahead of print.] 3. Varkas G, Thevissen K, De Brabanter Get al.   An induction or flare of arthritis and/or sacroiliitis by vedolizumab in inflammatory bowel disease: a case series. Ann Rheum Dis  2017; 76: 878– 81. Google Scholar CrossRef Search ADS PubMed  4. Sands BE, Kozarek R, Spainhour Jet al.   Safety and tolerability of concurrent natalizumab treatment for patients with Crohn’s disease not in remission while receiving infliximab. Inflamm Bowel Dis  2007; 13: 2– 11. Google Scholar CrossRef Search ADS PubMed  5. Buer LHM, Medhus AW, Moum B. Combination treatment with vedolizumab 1043 and anti-TNF-α in inflammatory bowel disease: safety data. J Crohns Colitis  2017; submited. Copyright © 2017 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com

Journal

Journal of Crohn's and ColitisOxford University Press

Published: Mar 1, 2018

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