scholarly journals Incidence rates of inflammatory bowel disease in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis treated with secukinumab: a retrospective analysis of pooled data from 21 clinical trials

2019 ◽  
Vol 78 (4) ◽  
pp. 473-479 ◽  
Author(s):  
Stefan Schreiber ◽  
Jean-Frederic Colombel ◽  
Brian G Feagan ◽  
Kristian Reich ◽  
Atul A Deodhar ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Bowel Disease ◽  
Pooled Analysis ◽  
Incidence Rates ◽  
Inflammatory Bowel ◽  
Adjusted Incidence ◽  
New Onset

ObjectivesHere, we present the reported incidence rates of inflammatory bowel disease (IBD) in patients receiving treatment with secukinumab for psoriasis (PsO), psoriatic arthritis (PsA) or ankylosing spondylitis (AS), in a pooled analysis of 21 clinical trials.MethodsData from all patients who had received at least one dose of secukinumab were included. Safety analyses were conducted to evaluate cumulative IBD rates as well as per-year rates, by indication. Crohn’s disease (CD), ulcerative colitis (UC) and IBD unclassified (IBDU) events were analysed using exposure-adjusted incidence rates (patient incidence rates per 100 patient-years (PY)).ResultsA total of 7355 patients with a cumulative exposure of 16 226.9 PY were included in the pooled analysis. Among 5181 patients with PsO, there were 14 cases of UC, 5 cases of CD and 1 case of IBDU, with exposure adjusted incidence rates (EAIRs) of 0.13, 0.05 and 0.01, respectively. Of these 20 cases, 14 were new-onset. In 1380 patients with PsA, there were 3 cases of UC, 3 cases of CD and 2 cases of IBDU (EAIRs 0.08, 0.08 and 0.05); 7 of these represented new-onset cases. Among 794 patients with AS, there were 4 cases of UC, 8 cases of CD and 1 case of IBDU (EAIRs 0.2, 0.4 and 0.1); 9 were new-onset cases. In the per year analysis, the EAIRs for each indication did not increase over time with secukinumab treatment.ConclusionsIn this pooled secukinumab safety analysis of 7355 patients across 21 clinical trials, cases of IBD events (including CD, UC and IBDU) were uncommon.

scholarly journals A194 A POSSIBLE ASSOCIATION BETWEEN SECUKINUMAB AND NEW-ONSET INFLAMMATORY BOWEL DISEASE: A CASE SERIES

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 216-217
Author(s):  
A Sarker ◽  
T Shukla ◽  
A Rostom ◽  
J Sim ◽  
J D McCurdy
Keyword(s):  
Inflammatory Bowel Disease ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Autoimmune Diseases ◽  
Bowel Disease ◽  
Intestinal Inflammation ◽  
Gastrointestinal Symptoms ◽  
Case Series ◽  
Inflammatory Bowel ◽  
New Onset

Abstract Background Secukinumab is a monoclonal antibody targeting interleukin-17A and is commonly used for managing autoimmune diseases such as, psoriasis, psoriatic arthritis, and ankylosing spondylitis. Prior studies have suggested that anti-IL17 therapy may worsen symptoms in patients with pre-existing inflammatory bowel disease (IBD). However, it remains unclear if secukinumab is associated with new-onset IBD or in provoking a flare of previously quiescent IBD. Aims We evaluated patients referred to our IBD clinic who developed intestinal inflammation after starting secukinumab for the management of autoimmune diseases. Methods We performed a retrospective, observational study at a single tertiary care center between 2017 and 2020. Patients referred to our IBD clinic who developed intestinal inflammation after starting secukinumab were included. We excluded patients with an established pre-existing diagnosis of IBD and patients who had positive stool testing for infectious organisms. Patient demographics, disease characteristics, distribution of intestinal inflammation and clinical outcomes were assessed. The pathology slides were reinterpreted by a single pathologist with a specialty in gastroenterology to determine the histologic characteristics of the inflammation. Results A total of 8 patients developed gastrointestinal symptoms after starting secukinumab: 4 (50%) males with a median age of 42.5 (IQR: 35–50 years old). Secukinumab was initiated for psoriasis in 3 (37.5%) patients, psoriatic arthritis in 2 (25%) patients, ankylosing spondylitis in 2 (25%) patients and juvenile idiopathic arthritis in 1 (12.5%) patient. The median time of onset for gastrointestinal symptoms after starting secukinumab was 7 months (IQR: 4–15 months). Of the patients who underwent testing for inflammatory biomarkers, the median CRP was 25.5 (IQR 25.4–34.2). Endoscopic disease distribution involved the colon in 5 (62.5%) patients and the ileum and colon in 3 (37.5%) patients. In this series of patients, the histologic characteristics demonstrated three patterns of colitis: IBD-like (ulcerative colitis or Crohn’s disease) in 6 (75%) patients based on mucosal granulomas and/or chronic inflammatory changes, MMF-like histology in 1 (12.5%) patient, characterized by an abundance of intraepithelial eosinophils in the lamina propria and numerous crypt apoptotic bodies, and finally active colitis in 1 (12.5%) patient characterized by an absence of chronic mucosal injury or granulomas. The treatment for these patients was cessation of secukinumab and initiating alternative therapies with close clinical monitoring. Conclusions In this small case series, Secukinumab was temporally associated with the development of gastrointestinal inflammation. Further larger studies are required to confirm this association and to determine if IL-17 contributes to the pathogenesis of IBD. Funding Agencies None

Inflammatory bowel disease and new-onset psychiatric disorders in pregnancy and post partum: a population-based cohort study

Gut ◽  
2019 ◽  
Vol 68 (9) ◽  
pp. 1597-1605 ◽  
Author(s):  
Simone N Vigod ◽  
Paul Kurdyak ◽  
Hilary K Brown ◽  
Geoffrey C Nguyen ◽  
Laura E Targownik ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Mental Illness ◽  
Cohort Study ◽  
Bowel Disease ◽  
Post Partum ◽  
Population Based ◽  
Incidence Rates ◽  
Increased Risk ◽  
Inflammatory Bowel ◽  
New Onset

ObjectivePatients with inflammatory bowel disease (IBD) have an elevated risk of mental illness. We determined the incidence and correlates of new-onset mental illness associated with IBD during pregnancy and post partum.DesignThis cohort study using population-based health administrative data included all women with a singleton live birth in Ontario, Canada (2002–2014). The incidence of new-onset mental illness from conception to 1-year post partum was compared between 3721 women with and 798 908 without IBD, generating adjusted HRs (aHR). Logistic regression was used to identify correlates of new-onset mental illness in the IBD group.ResultsAbout 22.7% of women with IBD had new-onset mental illness versus 20.4% without, corresponding to incidence rates of 150.2 and 132.8 per 1000 patient-years (aHR 1.12, 95% CI 1.05 to 1.20), or one extra case of new-onset mental illness per 43 pregnant women with IBD. The risk was elevated in the post partum (aHR 1.20, 95% CI 1.09 to 1.31), but not during pregnancy, and for Crohn’s disease (aHR 1.12, 95% CI 1.02 to 1.23), but not ulcerative colitis. The risk was specifically elevated for a new-onset mood or anxiety disorder (aHR 1.14, 95% CI 1.04 to 1.26) and alcohol or substance use disorders (aHR 2.73, 95% CI 1.42 to 5.26). Predictors of a mental illness diagnosis were maternal age, delivery year, medical comorbidity, number of prenatal visits, family physician obstetrical care and infant mortality.ConclusionWomen with IBD were at an increased risk of new-onset psychiatric diagnosis in the postpartum period, but not during pregnancy. Providers should look to increase opportunities for prevention, early identification and treatment accordingly.

THU0393 INFLAMMATORY BOWEL DISEASES AMONG SECUKINUMAB-TREATED PATIENTS: 24 CASES FROM THE MISSIL REGISTRY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 431.1-431
Author(s):  
J. G. Letarouilly ◽  
B. Pariente ◽  
D. Staumont-Sallé ◽  
P. Goupille ◽  
P. Claudepierre ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Clinical Trials ◽  
Real World ◽  
Bowel Disease ◽  
Research Support ◽  
Real World Data ◽  
Pooled Data ◽  
Bowel Diseases ◽  
Inflammatory Bowel ◽  
New Onset

Background:An alert regarding about the tolerance of Interleukin 17 (IL-17) inhibitors has been issued from data of randomized controlled trials showing cases of de novo inflammatory bowel diseases (IBD). In a recent analysis of pooled data from 21 clinical trials, cases of IBD events (including Crohn’s disease (CD), ulcerative colitis (UC) and inflammatory bowel disease unclassified (IBDU)) were uncommon (1). Yet, real-world data are lacking.Objectives:To describe real-world data about patients treated by IL-17 inhibitors developing new onset IBD (CD or UC).Methods:A French national registry called MISSIL was started in February 2018 to collect the cases of patients treated by IL-17 inhibitors developing new onset IBD. This registry is conducted by rheumatologist, dermatologist and gastroenterologist learned societies specialized on immune-mediated inflammatory diseases. In France, secukinumab (SEK) has been granted market authorization since June 2016 and ixekizumab since April 2018.Results:24 cases under SEK were reported between February 2018 and January 2020: 3 patients with psoriasis and 21 patients with spondylwoarthritis. There were 20 patients with new onset CD and 4 with UC. Mean age was 51.7 ± 15.7 years old and 12/24 were female; 10 presented an axial spondyloarthritis, 5 a peripheral spondyloarthritis and 6 both,13/17 were HLA-B27 positive,7/19 had a radiographic sacroiliitis and 11/17 a MRI sacroiliitis. Only 2 were biological Disease-modifying antirheumatic drug (bDMARD)-naïve. Crohn’s disease was mainly located at the ileum, colon and rectum. The median time to onset of symptoms was 2 (1-6) months. The main symptoms were diarrhea, nausea and vomiting and loss of weight. Median CRP at the onset of symptoms was 68 mg/L (41-140.5); 21 patients underwent biopsies, 12 were in favor of CD. IL-17 inhibitors were consistently stopped. Patients were treated by corticosteroids (16/24), mesalazine (7/24), methotrexate (3/24), thiopurines (2/24), infliximab (9/243), adalimumab (3/24), golimumab (2/24), ustekinumab (5/24). The evolution was favorable under treatment with complete resolution (4/24), improvement (11/24) or stabilization (5/24). 3 patients worsened under treatment and 1 died (massive myocardial infarction).Conclusion:IBD flare in patients treated with IL-17 inhibitors are rare and lead to discuss the potential iatrogenic role of IL-17 inhibitor drugs. Further cases are needed to better characterize this complication. A case-control study will be conducted to identify patients at risk to develop IBD under IL-17 inhibitor.References:[1]Reich et al. Incidence rates of inflammatory bowel disease in patients with psoriasis, psoriatic arthritis and ankylosing spondylitis treated with secukinumab: a retrospective analysis of pooled data from 21 clinical trials. Ann Rheum Dis. 2019;78:473-479Disclosure of Interests:Jean-Guillaume Letarouilly Grant/research support from: Research grant from Pfizer, Benjamin Pariente: None declared, Delphine Staumont-Sallé Speakers bureau: Lilly, Novartis, Philippe Goupille Grant/research support from: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Pascal Claudepierre Speakers bureau: Janssen, Novartis, Lilly, Stephane Varin: None declared, Sylvain Lanot: None declared, Emmanuelle Dernis Speakers bureau: Lilly, Novartis, Tristan Pascart Speakers bureau: Novartis, Lilly, Beatrice Banneville Speakers bureau: Lilly, Novartis, Pauline Baudart: None declared, Bruno Gombert: None declared, Elodie BAUER: None declared, Laurianne Plastaras: None declared, Sébastien Barbarot: None declared, Renaud FELTEN: None declared, Loïc Le Dantec: None declared, Nathalie Sultan-Bichat: None declared, Céline Girard: None declared, Arnaud Constantin Grant/research support from: Study was sponsored by Sanofi Genzyme, Consultant of: Consulting fees from Abbvie, BMS, Celgene, Gilead, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, UCB, Daniel Wendling: None declared, Philippe Gaudin Speakers bureau: Lilly, Denis Jullien Speakers bureau: Lilly, Novartis, Thao Pham Speakers bureau: Novartis, Janssen, Lilly, Rene-Marc Flipo Speakers bureau: Novartis, Janssen, Lilly

scholarly journals Undifferentiated seronegative spondyloarthritis with inflammatory bowel disease and a family history of psoriasis. Sicca syndrome

2013 ◽  
pp. 189-191
Author(s):  
Norma Marigliano ◽  
Domenico Galasso
Keyword(s):  
Inflammatory Bowel Disease ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Bowel Disease ◽  
Acute Inflammation ◽  
Clinical Manifestations ◽  
Hla B27 ◽  
History Of ◽  
Seronegative Spondyloarthritis ◽  
Inflammatory Bowel

Background: Seronegative spondyloarthritis is characterized by the presence of subcutaneous nodules, asymmetrical peripheral arthritis, sacroileitis with or without spondylitis, and rheumatoid-factor negativity. Other common clinical manifestations include oral ulcers, conjunctivitis, and cutaneous lesions such as psoriasis. Familial aggregation has also been described. According to the 1986 classification, corresponding clinical entities include ankylosing spondylitis, psoriatic arthritis, Reiter’s syndrome, arthritis associated with inflammatory bowel disease (IBD), and undifferentiated spondyloarthritis. The disease is also frequently associated with the HLA B27 antigen. From the clinical point of view, there are often incomplete forms of spondyloarthritis, such as reactive arthritis triggered by asymptomatic infections, psoriatic arthritis without psoriasis itself, initial phases of specific forms of spondyloarthritis or the phase of ankylosing spondylitis characterized by sacroiliac lesions, and all forms that remain undifferentiated for long periods of time. Moreover, there are close relations between arthropathy and IBDs, such as Crohn’s disease, ulcerative colitis, and Whipple’s syndrome. Recently, microscopic inflammatory bowel lesions and psoriatic arthritis have been described. Case report: A 30-year-old man (HLA B27-negative) who had been vaccinated against TBC and HBV presented with a 6-year history of recurrent episodes of predominantly left-sided sciatica. The pain was worse at night and during rest. He was suffering from bilateral sacroileitis without spondylitis. Three to five times a day, usually after eating, he passed watery feces containing mucous and small amounts of bright red blood. Colonoscopy revealed pancolitis with histological evidence of chronic inflammation interspersed with areas of acute inflammation, edema, hyperemia, and glandular distortion. One year later, the clinical manifestations and histological findings were essentially unchanged: glandular distortions, chronic and acute inflammation of the lamina propria and crypt microabscesses. There were no granulomas and no evidence of uveitis. The inflammatory index was positive; FR, ENA, ANA titers were negative. He began therapy with adalimumab (loading dose 80 mg followed by 40 mg every 15 days) and mesalazine (2.4 g per os), and the clinical manifestations of the disease improved significantly.

scholarly journals A Rare Case of New-Onset Ulcerative Colitis following Initiation of Secukinumab

2019 ◽  
Vol 2019 ◽  
pp. 1-5 ◽  
Author(s):  
Ted George Achufusi ◽  
Prateek S. Harnee ◽  
Sekou Rawlins
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Monoclonal Antibody ◽  
Psoriatic Arthritis ◽  
Ankylosing Spondylitis ◽  
Adverse Effects ◽  
Rare Case ◽  
Young Male ◽  
Inflammatory Bowel ◽  
New Onset

Secukinumab is an IgG monoclonal antibody widely used for treatment of ankylosing spondylitis, psoriasis, and psoriatic arthritis. Recently, there has been increasing controversy regarding potential adverse effects of the drug especially in those with underlying inflammatory bowel disease. We present the case of a young male patient who developed severe new-onset ulcerative colitis following initiation of secukinumab for psoriasis, with excellent response and rapid resolution of symptoms with infliximab.

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