Biosimilar adalimumab FKB-327 in the treatment of inflammatory bowel disease

2020 ◽  
Vol 74 (6) ◽  
pp. 553-557
Author(s):  
Milan Lukáš ◽  
Martin Vašátko ◽  
Martin Lukáš ◽  
Martin Kolář ◽  
Dana Ďuricová ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Therapeutic Effect ◽  
Drug Administration ◽  
Bowel Disease ◽  
Biologic Therapy ◽  
Positive Therapeutic Effect ◽  
Inflammatory Bowel

In 2018 year, the patent of original adalimumab expired and a new biosimilar version of adalimumab have been introduced on the Czech market. FKB-327 is one of the new biosimilar adalimumab versions and was approved for all indication of the original drug. This is the first experience with biosimilar adalimumab FKB-327 in IBD patients. Patients cohort comprised from 51 patients included 40 (82%) ones with Crohn´s disease and 9 (18%) ones with ulcerative colitis. Most of the patients (78%) have been naive for biologic therapy. A positive therapeutic effect during the median follow up time (37 weeks) was described in 47 (92%) patients. This drug was tolerated very well and none of the treated patients had to stop prematurely the drug administration due to significant side effects.

scholarly journals P605 Eight-year efficacy and safety of azathioprine treatment in the maintenance of steroid-free remission in inflammatory bowel disease patients

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S505-S505
Author(s):  
C Cassieri ◽  
R Pica ◽  
E V Avallone ◽  
G Brandimarte ◽  
M Zippi ◽  
...  
Keyword(s):  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Bowel Disease ◽  
Efficacy And Safety ◽  
Loss Of Response ◽  
Steroid Dependent ◽  
Azathioprine Treatment ◽  
Inflammatory Bowel ◽  
Maintenance Of Remission

Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid-dependent patients with inflammatory bowel disease (IBD). The aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid-dependent IBD patients eight years after the institution of treatment. Methods Data from consecutive IBD outpatients referred in our Institution, between 1985–2017, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2–2.5 mg/kg. Results Out of 2992 consecutive IBD outpatients visited in the index period, AZA was prescribed to 446 patients, 245 (54.9%) were affected by Crohn’s disease (CD) and 201 (45.1%) by ulcerative colitis (UC). One hundred and ninety-six patients with a follow-up < 96 months were excluded from the study. Two hundred and fifty patients were evaluated, 140 (56%) with CD and 110 (44%) with UC. One hundred and thirty-eight (55.2%) were male and 112 (44.8%) female (average age of 35.48 ± 14.26 SD years, range 14–74 years). Eight year after the institution of treatment, 123 (49.2%) patients still were in steroid-free remission (82 CD vs. 41 UC, 58.6% and 37.3%, respectively, p = 0.0009), 71 (28.4%) had a relapse requiring retreatment with steroids (29 CD vs. 42 UC, 20.7% and 38.2%, respectively, p = 0.0030), 56 (22.4%) discontinued the treatment due to side effects (29 CD vs. 27 UC, 20.7% and 24.5%, respectively). The loss of response from first to eighth year of follow-up was low, about 21%. Conclusion Eight years after the onset of treatment about 50% of patients did not require further steroid courses. After the first-year loss of response was low in seven subsequent years. In the present series, the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low.

scholarly journals Articular manifestations in patients with inflammatory bowel disease treated with vedolizumab

Rheumatology ◽  
2020 ◽  
Vol 59 (11) ◽  
pp. 3275-3283 ◽  
Author(s):  
Anastasia Dupré ◽  
Michael Collins ◽  
Gaétane Nocturne ◽  
Franck Carbonnel ◽  
Xavier Mariette ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Inflammatory Bowel Diseases ◽  
Bowel Disease ◽  
Bowel Diseases ◽  
History Of ◽  
Musculoskeletal Manifestations ◽  
Inflammatory Bowel

Abstract Objective Vedolizumab (VDZ) has been incriminated in the occurrence of articular manifestations in patients with inflammatory bowel diseases (IBDs). The aim of this study was to describe musculoskeletal manifestations occurring in IBD patients treated by VDZ and to identify risk factors. Methods In this retrospective monocentric study, we included all consecutive patients treated by VDZ for IBD in our hospital. Incident musculoskeletal manifestations occurring during VDZ treatment were analysed and characteristics of patients with and without articular inflammatory manifestations were compared. Results Between 2013 and 2017, 112 patients were treated with VDZ for IBD: ulcerative colitis (n = 59), Crohn’s disease (n = 49) and undetermined colitis (n = 4). Four patients (3.6%) had a history of SpA, whereas 13 (11.6%) had a history of peripheral arthralgia. Some 102 (91.1%) patients had previously received anti-TNF. After a mean (S.d.) follow-up of 11.4 (8.6) months, 32 (28.6%) patients presented 35 musculoskeletal manifestations, of which 18 were mechanical and 17 inflammatory. Among the latter, 11 had axial or peripheral SpA, 5 had early reversible arthralgia and 1 had chondrocalcinosis (n = 1). Among the 11 SpA patients, only 3 (2.6%) had inactive IBD and may be considered as paradoxical SpA. The only factor associated with occurrence of inflammatory manifestations was history of inflammatory articular manifestation [7/16 (43.8%) vs 10/80 (12.5%), P = 0.007]. Conclusion Musculoskeletal manifestations occurred in almost 30% of IBD patients treated with VDZ, but only half of them were inflammatory. Since most of the patients previously received anti-TNF, occurrence of inflammatory articular manifestations might rather be linked to anti-TNF discontinuation than to VDZ itself.

scholarly journals Overview of 5-ASA in Therapy of Inflammatory Bowel Disease

1994 ◽  
Vol 8 (6) ◽  
pp. 379-382 ◽  
Author(s):  
CN Williams
Keyword(s):  
Ulcerative Colitis ◽  
Drug Delivery ◽  
Inflammatory Bowel Disease ◽  
Side Effects ◽  
Bowel Disease ◽  
Therapeutic Benefit ◽  
Effective Dosage ◽  
Free Oxygen Radicals ◽  
Aminosalicylic Acid ◽  
Inflammatory Bowel

There are two forms of 5-aminosalicylic acid (5-ASA) drug delivery. First, a pro-drug form in which 5-ASA, the active principal, is attached to a c.arrier molecule and released in the intestine by bacterial cleavage. An example of this is sulfasalazine, originally developed in the 1940s and found to be effective, cheap, but limited by side effects due to the sulfapyridine component. The second drug delivery system depends on an enteric coating for delayed pH-dependent release or for a timed-released mechanism. 5-ASA inhibits 5-lipoxygenase, modulates leukocyte function and inhibits soluble mediator release, and is an effective scavenger action of free oxygen radicals, the relative importance of which is unknown. The multiplicity of action is probably its strength because drugs that have only one of these actions are relatively ineffective in inflammatory bowel disease. 5-ASA compounds are effective in treating mild to moderate acute ulcerative colitis and in maintaining remission, and are equivalent to sulfasalazine in this regard. 5-ASA used topically in enema or suppository form is highly efficient in both acute disease and in maintaining remission. 5-ASA is also effective in active Crohn’s disease, but not as effective as in maintenance therapy compared with ulcerative colitis. The pro-drugs tend to have more side effects. Slow release compounds are well tolerated with few side effects, allowing increases to effective dosage. In patients intolerant of sulfasalazine, switching to a 5-ASA preparation usually results in tolerance and therapeutic benefit, with an occasional allergic reaction to the 5-ASA molecule limiting its use.

scholarly journals Chronic cough in a patient with stable ulcerative colitis: a rare but important extraintestinal manifestation of inflammatory bowel disease

2019 ◽  
Vol 12 (1) ◽  
pp. bcr-2018-227066 ◽  
Author(s):  
Thomas Chad ◽  
Jeremy Brown
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Bowel Disease ◽  
Lower Lobe ◽  
Gas Transfer ◽  
Extraintestinal Manifestation ◽  
Sputum Production ◽  
Inflammatory Bowel ◽  
The Right

A 74-year-old woman presented to her general practitioner with cough and occasional sputum production. Having failed to respond to courses of antibiotics in the community, she was referred to the thoracic medicine clinic. High-resolution CT chest revealed cylindrical bronchiectasis predominantly in the right lower lobe. Lung function revealed preserved FEV1 and FVC but reduced gas transfer values. Bronchiectasis secondary to ulcerative colitis was diagnosed. Inhaled corticosteroid therapy was initiated, with good clinical response noted at 6 monthly follow-up. Remission was sustained with tapering of the steroid dose. Recognition of respiratory complications in cases of inflammatory bowel disease is likely still poor among clinicians. Although rare, a working knowledge of principles of investigation and management will aid timely diagnosis and treatment, potentially preventing progression of respiratory disease.

scholarly journals Association of ulcerative colitis and IgA nephropathy: A case report

2021 ◽  
pp. 105-107
Author(s):  
Boulajaad S ◽  
Haida M ◽  
Errami Ait ◽  
Oubaha S ◽  
Samlani Z ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Iga Nephropathy ◽  
Bowel Disease ◽  
Renal Involvement ◽  
Chronic Inflammatory Bowel Disease ◽  
Secondary Amyloidosis ◽  
Inflammatory Bowel ◽  
Chronic Inflammatory Bowel

The extradigestive manifestations of chronic inflammatory bowel disease most often affect the articulations, skin, eyes, liver and bile ducts. Renal involvement is rare, and manifests as kidney stones, glomerulonephritis, tubulointerstitial nephritis, and secondary amyloidosis. In this context of chronic inflammatory bowel disease, in particular ulcerative colitis, renal involvement is very often secondary to nephrotoxicity of the basic treatment of digestive pathology, and very rarely an authentic extradigestive manifestation of intestinal disease. We report a case of IgA nephropathy as an extra-digestive manifestation of ulcerative colitis. The objective of this study is not to neglect the IgA nephtopathy as an extradigestive manifestation of IBD which, even though rare, remains a condition to be looked for by clinicians during the follow-up of IBD.

scholarly journals Intestinal Ultrasound in Inflammatory Bowel Disease: A Valuable and Increasingly Important Tool

2021 ◽  
pp. 1-17
Author(s):  
Catarina Frias-Gomes ◽  
Joana Torres ◽  
Carolina Palmela
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Disease Activity ◽  
Bowel Disease ◽  
Response To Therapy ◽  
Inflammatory Bowel

<b><i>Background:</i></b> Intestinal ultrasound is emerging as a non-invasive tool for monitoring disease activity in inflammatory bowel disease patients due to its low cost, excellent safety profile, and availability. Herein, we comprehensively review the role of intestinal ultrasound in the management of these patients. <b><i>Summary:</i></b> Intestinal ultrasound has a good accuracy in the diagnosis of Crohn’s disease, as well as in the assessment of disease activity, extent, and evaluating disease-related complications, namely strictures, fistulae, and abscesses. Even though not fully validated, several scores have been developed to assess disease activity using ultrasound. Importantly, intestinal ultrasound can also be used to assess response to treatment. Changes in ultrasonographic parameters are observed as early as 4 weeks after treatment initiation and persist during short- and long-term follow-up. Additionally, Crohn’s disease patients with no ultrasound improvement seem to be at a higher risk of therapy intensification, need for steroids, hospitalisation, or even surgery. Similarly to Crohn’s disease, intestinal ultrasound has a good performance in the diagnosis, activity, and disease extent assessment in ulcerative colitis patients. In fact, in patients with severe acute colitis, higher bowel wall thickness at admission is associated with the need for salvage therapy and the absence of a significant decrease in this parameter may predict the need for colectomy. Short-term data also evidence the role of intestinal ultrasound in evaluating therapy response, with ultrasound changes observed after 2 weeks of treatment and significant improvement after 12 weeks of follow-up in ulcerative colitis. <b><i>Key Messages:</i></b> Intestinal ultrasound is a valuable tool to assess disease activity and complications, and to monitor response to therapy. Even though longer prospective data are warranted, intestinal ultrasound may lead to a change in the paradigm of inflammatory bowel disease management as it can be used in a point-of-care setting, enabling earlier intervention if needed.

scholarly journals Real-world Effectiveness and Safety of Vedolizumab for the Treatment of Inflammatory Bowel Disease: The Scottish Vedolizumab Cohort

2019 ◽  
Vol 13 (9) ◽  
pp. 1111-1120 ◽  
Author(s):  
N Plevris ◽  
C S Chuah ◽  
R M Allen ◽  
I D Arnott ◽  
P N Brennan ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Real World ◽  
Bowel Disease ◽  
Clinical Remission ◽  
Mucosal Healing ◽  
Inflammatory Bowel

Abstract Background & Aims Vedolizumab is an anti-a4b7 monoclonal antibody that is licensed for the treatment of moderate to severe Crohn’s disease and ulcerative colitis. The aims of this study were to establish the real-world effectiveness and safety of vedolizumab for the treatment of inflammatory bowel disease. Methods This was a retrospective study involving seven NHS health boards in Scotland between June 2015 and November 2017. Inclusion criteria included: a diagnosis of ulcerative colitis or Crohn’s disease with objective evidence of active inflammation at baseline (Harvey–Bradshaw Index[HBI] ≥5/Partial Mayo ≥2 plus C-reactive protein [CRP] >5 mg/L or faecal calprotectin ≥250 µg/g or inflammation on endoscopy/magnetic resonance imaging [MRI]); completion of induction; and at least one clinical follow-up by 12 months. Kaplan–Meier survival analysis was used to establish 12-month cumulative rates of clinical remission, mucosal healing, and deep remission [clinical remission plus mucosal healing]. Rates of serious adverse events were described quantitatively. Results Our cohort consisted of 180 patients with ulcerative colitis and 260 with Crohn’s disease. Combined median follow-up was 52 weeks (interquartile range [IQR] 26–52 weeks). In ulcerative colitis, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 57.4%, 47.3%, and 38.5%, respectively. In Crohn’s disease, 12-month cumulative rates of clinical remission, mucosal healing, and deep remission were 58.4%, 38.9%, and 28.3% respectively. The serious adverse event rate was 15.6 per 100 patient-years of follow-up. Conclusions Vedolizumab is a safe and effective treatment for achieving both clinical remission and mucosal healing in ulcerative colitis and Crohn’s disease.

scholarly journals Women’s earnings are more affected by inflammatory bowel disease than men’s: a register-based Swedish cohort study

2020 ◽  
Author(s):  
Åsa H Everhov ◽  
Gustaf Bruze ◽  
Jonas Söderling ◽  
Johan Askling ◽  
Jonas Halfvarson ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Inflammatory Bowel Disease ◽  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Bowel Disease ◽  
Disposable Income ◽  
Inflammatory Bowel ◽  
The Individual ◽  
Annual Earnings

Abstract Background/Aim Patients with inflammatory bowel disease (IBD) have more work disability than the general population. We aimed to estimate the monetary cost of IBD for the individual through assessment of earnings in relation to diagnosis. Methods Through linkage of national registers we identified patients aged 30-55 years at first IBD diagnosis in Sweden 2002-2011, and same-sex IBD-free siblings. We estimated taxable earnings and disposable income from 5 years before to 5 years after diagnosis. Results The 5,961 patients (27% Crohn’s disease, 68% ulcerative colitis, 4.3% IBD unclassified) had similar taxable earnings as their 7,810 siblings until the year of diagnosis, when earnings decreased and remained lower than in siblings during follow-up. The adjusted difference in earnings over the entire 5-year period after diagnosis was -5% (-8,212€; 95%CI: -11,458 to-4,967). The difference was larger in women than in men, and larger in Crohn’s disease than in ulcerative colitis. When stratifying for sex and IBD subtype and comparing earnings during each year of follow-up, the median annual earnings were lower in women with Crohn’s disease and ulcerative colitis than in their sisters during all years of follow-up, whereas the men had similar annual taxable earnings as their brothers. The disposable income was similar between patients and siblings during the investigated time period. Conclusion From the year of diagnosis and at least 5 years onwards, patients with IBD had 5% lower earnings than siblings, mainly explained by differences between women with IBD and their sisters. However, there were no differences in disposable income.

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