Publications by authors named "Claus Aalykke"

10 Publications

  • Page 1 of 1

Vedolizumab as first-line biological therapy in elderly patients and those with contraindications for anti-TNF therapy: a real-world, nationwide cohort of patients with inflammatory bowel diseases.

Scand J Gastroenterol 2021 09 5;56(9):1040-1048. Epub 2021 Jul 5.

Gastrounit, Medical Division, Copenhagen University Hospital, Hvidovre, Denmark.

Background: Data from real-life populations about vedolizumab as first-line biological therapy for ulcerative colitis (UC) and Crohn's disease (CD) are emerging.

Objective: To investigate the efficacy and safety of vedolizumab in bio-naïve patients with UC and CD.

Methods: A Danish nationwide cohort study was conducted between November 2014 and November 2019. Primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission from weeks 14 through 52.

Results: The study included 56 patients (UC:31, CD:25) who initiated treatment with vedolizumab mainly because of contraindications to anti-TNFs, of whom 54.8 and 24.0%, respectively received systemic steroids at the initiation. Rates of clinical remission at weeks 6, 14, and 52 were 32.0, 48.0, and 40.0%, respectively, in UC, and 36.8, 36.8, and 47.4% in CD. Steroid-free clinical remission at week 52 was achieved among 36.0 and 47.4% of UC and CD patients, while sustained clinical remission was achieved in 32.0 and 36.8%. Lack of remission was associated with being female (68.8 11.1%,  .01) in UC and non-structuring, non-penetrating behavior in CD (90.0 44.4%,  = .03); however, this was not confirmed in multivariate analysis. Discontinuation due to primary non-response occurred in 20.0 and 5.3% of UC and CD patients, respectively, while rates of secondary loss of response were 12.0 and 5.3% after 52 weeks of follow-up. Vedolizumab was well-tolerated as only one UC patient experienced a serious adverse event.

Conclusion: Vedolizumab is effective in the achievement of short-term, long-term, and steroid-free clinical remission in bio-naïve UC and CD patients.
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http://dx.doi.org/10.1080/00365521.2021.1946588DOI Listing
September 2021

The Prognostic Value of Pain Phenotyping in Relation to Treatment Outcomes in Patients with Axial Spondyloarthritis Treated in Clinical Practice: A Prospective Cohort Study.

J Clin Med 2021 Apr 2;10(7). Epub 2021 Apr 2.

Section for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, 2000 Copenhagen, Denmark.

Despite the control of inflammation, many patients with axial spondyloarthritis (axSpA) still report pain as a significant concern. Our objective was to explore the prognostic value of the painDETECT questionnaire (PDQ) in relation to treatment outcomes in axSpA patients treated in clinical practice. AxSpA patients with high disease activity initiating or switching a biological Disease-Modifying Antirheumatic Drug (bDMARD) were eligible. The PDQ score (range: -1 to 38) was used to distinguish participants with nociceptive pain (NcP) mechanisms from participants with a mixed pain mechanism (MP). The primary outcome was the proportion of individuals achieving a 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI50) at 12 weeks; logistic regression analysis models were used to determine the prognostic value of the nociceptive pain phenotype. Changes in continuous outcomes such as the Assessment of SpondyloArthritis International Society (ASAS) core outcome domains were analyzed using analysis of covariance (ANCOVA). Health-related quality of life (HR-QoL) was addressed using the Medical Outcomes Study SF-36. During a period of 22 months, 49 axSpA patients were included. Twenty (41%) had an NcP phenotype according to the PDQ score. BASDAI50 responses were reported by 40% (8/20) and 28% (8/29) NcP and MP groups, respectively. However, a prognostic value was not found in relation to the primary outcome (crude odds ratio [95% confidence interval]: 1.75 [0.52 to 5.87]). Across most of the secondary outcomes, axSpA NcP phenotype patients were reported having the most improvements in the HR-QoL measures. These data indicate the influence of personalized management strategies according to patients' pain phenotypes for stratification of axSpA patients in randomized controlled trials.
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http://dx.doi.org/10.3390/jcm10071469DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8038186PMC
April 2021

Clinical characteristics of importance to outcome in patients with axial spondyloarthritis: protocol for a prospective descriptive and exploratory cohort study.

BMJ Open 2017 Jul 10;7(7):e015536. Epub 2017 Jul 10.

Department of Medicine, Section of Rheumatology, Odense University Hospital, Svendborg, Denmark.

Introduction: Spondyloarthritis (SpA) is a heterogeneous spectrum of rheumatic diseases with either predominantly axial inflammatory symptoms of the spine and sacroiliac joints or predominantly peripheral arthritis. The two main entities of axial SpA (axSpA) are ankylosing spondylitis or non-radiographic axSpA (nr-axSpA). Tumour necrosis factor-α inhibitors have revolutionised the treatment of patients with axSpA who failed to respond to non-steroidal anti-inflammatory drugs and physical therapy. Chronic pain is common in patients with SpA and may still persist despite the lack of signs of inflammation. This has led researchers to hypothesise that central pain sensitisation may play a role in the generation of chronic pain in SpA. The painDETECT Questionnaire (PDQ) is a screening tool developed to detect neuropathic pain components. The primary objective is to explore the prognostic value of the PDQ regarding treatment response in patients with axSpA 3 months after initiating a biological agent. Secondary aim is to evaluate the impact of extra-articular manifestations, comorbidities and patient-reported outcomes and elucidate if these factors influence treatment response.

Method And Analysis: We will include 60 participants (≥18 years of age) diagnosed with axSpA independent of main entity, who initiate or switch treatment of a biologic. Data will be collected at baseline and at endpoint following Danish clinical practice (≥3 months) of treatment with biologics. We will explore whether the PDQ and other phenotypical patient characteristics are prognostically important for response to biological therapy according to established response criteria like 50% improvement in the Bath Ankylosing Spondylitis Disease Activity Index (50%) and Ankylosing Spondylitis Disease Activity Score.

Ethics And Dissemination: The study is approved by the Region of Southern Denmark's Ethics committee (S-20160094) and has been designed in cooperation with patient representatives. The study is registered at clinicaltrials.gov (NCT02948608, pre-results). Dissemination will occur through publication(s) in international peer-reviewed journal(s).
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http://dx.doi.org/10.1136/bmjopen-2016-015536DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5734256PMC
July 2017

Inadvertent yellow fever vaccination of a patient with Crohn's disease treated with infliximab and methotrexate.

BMJ Case Rep 2016 Aug 29;2016. Epub 2016 Aug 29.

Section of Gastroenterology, Department of Medicine, Svendborg Hospital, Svendborg, Denmark.

We present a case of a 56-year-old woman with Crohn's disease, treated with methotrexate and infliximab, who inadvertently received yellow fever vaccination (YFV) prior to a journey to Tanzania. She was not previously vaccinated against YF. YFV contains live-attenuated virus, and is contraindicated in patients treated with immunosuppressive drugs. Following vaccination, the patient fell ill with influenza-like illness. Elevated transaminase levels and YF viremia were detected. Despite being immunocompromised, the patient did not develop more severe adverse effects. Neutralising antibodies to YF virus were detected on day 14 following vaccination and remained protective at least 10 months after vaccination. Limited data is available on outcomes of YFV in patients receiving immunosuppressive therapy, including biologics, and we report this case as a reminder of vigilance of vaccine recommendations in this population.
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http://dx.doi.org/10.1136/bcr-2016-215403DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5015127PMC
August 2016

Colonoscopy surveillance for dysplasia and colorectal cancer in patients with inflammatory bowel disease.

Dan Med J 2015 Jan;62(1):B4995

Department of Medicine, OUH, Svendborg Sygehus, 5700 Svendborg, Denmark.

The risk of colorectal cancer (CRC) and dysplasia in patients with inflammatory bowel disease (IBD) has been highly debated as risk estimates from different studies vary greatly. The present national Danish guideline on colonoscopy surveillance for dysplasia and colorectal cancer in patients with IBD is based on a thorough review of existing literature with particular focus on recent studies from Denmark revealing a lower risk of CRC than previously assumed. The overall risk of CRC in the Danish IBD population does not appear to be different from that of the background population; however, in some subgroups of patients the risk is increased. These subgroups of patients, who should be offered colonoscopy surveillance, include patients with ulcerative colitis having extensive disease and a long disease duration (10-13 years); early age at onset (less than 19 years of age) of ulcerative colitis; and patients with ulcerative colitis as well as Crohn's disease with a concomitant diagnosis of primary sclerosing cholangitis. A colonoscopy surveillance program is recommended in these subgroups with intervals ranging from every 3-6 months to every 5 years, using chromoendoscopy with targeted biopsies of the lesion and adjacent mucosa, instead of conventional colonoscopy with random biopsies. Preferably, the colonoscopy should be performed during clinical remission. If a lesion is detected the endoscopical resectability together with the pathology of the lesion and the adjacent mucosa determine how the lesion should be treated.
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January 2015

Do statins protect against upper gastrointestinal bleeding?

Br J Clin Pharmacol 2009 Apr;67(4):460-5

Research Unit of Clinical Pharmacology, University of Southern Denmark, Odense, Denmark.

Aims: Recently, an apparent protective effect of statins against upper gastrointestinal bleeding (UGB) was postulated in a post hoc analysis of a randomized trial. We aimed to evaluate the effect of statin use on acute nonvariceal UGB alone or in combinations with low-dose aspirin and other antithrombotic drugs.

Methods: A population-based case-control study was conducted in the County of Funen, Denmark. Cases (n = 3652) were all subjects with a first discharge diagnosis of serious UGB from a hospital during the period 1995 to 2006. Age- and gender-matched controls (10 for each case) (n = 36 502) were selected by a risk set sampling. Data on all subjects' drug exposure and past medical history were retrieved from a prescription database and from the County's patient register. Confounders were controlled by conditional logistic regression.

Results: The adjusted odds ratios (ORs) associating use of statins with UGB were 0.94 (0.78-1.12) for current use, 1.40 (0.89-2.20) for recent use and 1.42 (0.96-2.10) for past use. The lack of effect was consistent across most patient subgroups, different cumulative or current statin doses and different statin substances. In explorative analyses, a borderline significant protective effect was observed for concurrent users of low-dose aspirin [OR 0.43 (0.18-1.05)].

Conclusion: Statins do not prevent UGB, except possibly in users of low-dose aspirin.
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http://dx.doi.org/10.1111/j.1365-2125.2009.03362.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2679110PMC
April 2009

Spironolactone use and the risk of upper gastrointestinal bleeding: a population-based case-control study.

Br J Clin Pharmacol 2008 Aug 21;66(2):294-9. Epub 2008 Apr 21.

Research Unit of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Odense, Denmark.

Aims: Recent studies have suggested an increased risk of upper gastrointestinal bleeding (UGB) in spironolactone users. The aim was to confirm the association, identify the risk factors and quantify the absolute risk.

Methods: A population based case-control study was conducted in the County of Funen, Denmark. Cases (n = 3652) were all subjects with a first discharge diagnosis of serious UGB during the period 1995 to 2006. Age- and gender-matched controls (10 for each case) (n = 36 502) were selected by risk set sampling. Data on all subjects' drug exposure and past medical history were retrieved from a prescription database and from the County's patient register. Confounders were controlled by conditional logistic regression.

Results: The adjusted odds ratio (OR) associating current use of spironolactone with UGB was 2.7 [95% confidence interval (CI) 2.2, 3.2]. The risk increased with higher doses of spironolactone (5.4; 3.4, 8.6) for 100-mg tablets. No trend was found with increasing cumulative dose. The strongest association was found among users aged 55-74 years (OR 13.1; 6.5, 26.3). Current use of loop diuretics was also associated with an increased risk of UGB (1.9; 1.7, 2.1).

Conclusion: The use of spironolactone is associated with increased risk of UGB. The risk increases with higher doses.
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http://dx.doi.org/10.1111/j.1365-2125.2008.03205.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2492928PMC
August 2008

[Use of anti-thrombotic agents--monotherapy or combination and risk of upper gastrointestinal bleedings: a population-based case-control study. Secondary publication].

Ugeskr Laeger 2007 Apr;169(17):1577-9

Syddansk Universitet, Afdelingen for Klinisk Farmakologi, IST, Forskningsenheden for almen medicin, Odense.

The clinical use of anti-thrombotic agents has shifted towards more aggressive therapy and towards regimes with more than one drug. Data on the risk of upper gastrointestinal bleedings (UGB) with combined anti-thrombotic therapy are scarce. In the period 2000 through 2004, 1,443 cases of serious UGB and 57,720 control subjects were identified in Funen County. Anti-thrombotic therapy is becoming increasingly aggressive. Combined anti-thrombotic therapy confers particular risk and is associated with high incidence rates of GI bleeding.
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April 2007

Use of single and combined antithrombotic therapy and risk of serious upper gastrointestinal bleeding: population based case-control study.

BMJ 2006 Oct 19;333(7571):726. Epub 2006 Sep 19.

Department of Clinical Pharmacology, IST, Syddansk Universitet, 5000 Odense, Denmark.

Objectives: To assess the risk of serious upper gastrointestinal bleeding associated with the newer antithrombotic agents used alone or in combination with other antithrombotic drugs; to describe the trends in use of antithrombotic drugs in the background population.

Design: Population based case-control study.

Setting: Funen County, Denmark (population 470,000).

Subjects: 1443 cases of serious upper gastrointestinal bleeding identified during 2000-4; 57,720 age and sex matched controls.

Main Outcome Measure: Exposure to low dose aspirin, clopidogrel, dipyridamole, vitamin K antagonists, and combined antithrombotic treatment.

Results: Adjusted odds ratios associating drug use with upper gastrointestinal bleeding were 1.8 (95% confidence interval 1.5 to 2.1) for low dose aspirin, 1.1 (0.6 to 2.1) for clopidogrel, 1.9 (1.3 to 2.8) for dipyridamole, and 1.8 (1.3 to 2.4) for vitamin K antagonists. Corresponding figures for combined use were 7.4 (3.5 to 15) for clopidogrel and aspirin, 5.3 (2.9 to 9.5) for vitamin K antagonists and aspirin, and 2.3 (1.7 to 3.3) for dipyridamole and aspirin. Other combinations were used too infrequently to allow estimation. The number of treatment years needed to produce one excess case varied from 124 for the clopidogrel-aspirin combination to 8800 for clopidogrel alone. During the study period, exposure to combined antithrombotic regimens increased by 425% in the background population.

Conclusion: Antithrombotic treatment is becoming increasingly aggressive. Combined antithrombotic treatment confers particular risk and is associated with high incidence of gastrointestinal bleeding.
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http://dx.doi.org/10.1136/bmj.38947.697558.AEDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1592384PMC
October 2006
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