| 1. |
- Bergqvist, Viktoria, et al.
(författare)
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Switching from originator infliximab to the biosimilar CT-P13 in 313 patients with inflammatory bowel disease
- 2018
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Ingår i: Therapeutic Advances in Gastroenterology. - : SAGE Publications. - 1756-283X .- 1756-2848. ; 11
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: As the patents of originator biologics are expiring, biosimilar versions are becoming available for the treatment of inflammatory bowel disease (IBD). However, published switch studies of the first infliximab biosimilar, CT-P13, have delivered ambiguous results that could be interpreted as showing a trend towards inferior effectiveness in Crohn's disease (CD) compared with ulcerative colitis (UC). The aim of this study was to investigate the effectiveness and safety of switching IBD patients from treatment with Remicade to CT-P13.METHODS: In this prospective observational cohort study, all adult IBD patients on Remicade treatment, at four hospitals, were switched to CT-P13. The primary endpoint was change in clinical disease activity at 2, 6, and 12 months after the switch. Secondary endpoints were subgroup analyses of patients with and without concomitant immunomodulators; changes in biomarkers, quality of life, drug trough levels and anti-drug antibodies (ADAbs); and adverse events.RESULTS: A total of 313 IBD patients were switched (195 CD; 118 UC). There were no significant changes in clinical disease activity, quality of life, biomarkers (except a small but significant increase in albumin in CD) including F-calprotectin, drug trough levels, or proportion of patients in remission. Disease worsening rates were 14.0% for CD and 13.8% for UC; and 2.7% developed ADAbs and 2.2% developed serious adverse events.CONCLUSIONS: This is the largest study of switched IBD patients published to date, and it demonstrates that switching from Remicade to CT-P13 may be done with preserved therapeutic effectiveness and safety in both CD and UC.
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| 2. |
- Bergström, Stefan, et al.
(författare)
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Dual-headed Coincidence PET vs. Dedicated PET/CT in the Evaluation of Thoracic Malignancies
- 2010
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Ingår i: In Vivo. - 0258-851X .- 1791-7549. ; 24:2, s. 235-238
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Tidskriftsartikel (refereegranskat)abstract
- The aim of this study was to evaluate the usefulness of coincidence PET imaging as compared with dedicated PET/CT in cancer staging. Patients and Methods: Sixteen patients with thoracic malignancies referred to a PET/CT examination accepted to repeat the acquisition with a coincidence PET system. One experienced nuclear medicine physician compiled a report from the PET/CT examinations and the coincidence PET images. The reports were compared and evaluated according to the degree of agreement: no agreement, unsatisfactory, acceptable or satisfying agreement. Results: Satisfying or acceptable agreement between the PET/CT and the coincidence PET examination was found in 14 out of 16 patients (88%). The main issue for the examining physician was to anatomically locate the FDG uptake in the mediastinum in The coincidence PET images. Conclusion: The data from this small study imply that the staging results obtained with coincidence PET are in most cases concordant with those obtained with dedicated PET/CT.
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| 3. |
- Bergqvist, Viktoria, et al.
(författare)
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Vedolizumab treatment for immune checkpoint inhibitor-induced enterocolitis
- 2017
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Ingår i: Cancer Immunology and Immunotherapy. - : Springer Science and Business Media LLC. - 0340-7004 .- 1432-0851. ; 66:5, s. 581-592
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Tidskriftsartikel (refereegranskat)abstract
- Immune checkpoint inhibitors (ICPI), such as ipilimumab [anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4) antibody] and nivolumab or pembrolizumab [anti-programmed cell death protein-1 (PD-1) antibodies], improve survival in several cancer types. Since inhibition of CTLA-4 or PD-1 leads to non-selective activation of the immune system, immune-related adverse events (irAEs) are frequent. Enterocolitis is a common irAE, currently managed with corticosteroids and, if necessary, anti-tumor necrosis factor-α therapy. Such a regimen carries a risk of serious side-effects including infections, and may potentially imply impaired antitumor effects. Vedolizumab is an anti-integrin α4β7 antibody with gut-specific immunosuppressive effects, approved for Crohn’s disease and ulcerative colitis. We report a case series of seven patients with metastatic melanoma or lung cancer, treated with vedolizumab off-label for ipilimumab- or nivolumab-induced enterocolitis, from June 2014 through October 2016. Clinical, laboratory, endoscopic, and histologic data were analyzed. Patients initially received corticosteroids but were steroid-dependent and/or partially refractory. One patient was administered infliximab but was refractory. The median time from onset of enterocolitis to start of vedolizumab therapy was 79 days. Following vedolizumab therapy, all patients but one experienced steroid-free enterocolitis remission, with normalized fecal calprotectin. This was achieved after a median of 56 days from vedolizumab start, without any vedolizumab-related side-effects noted. The patient in whom vedolizumab was not successful, due to active ulcerative colitis, received vedolizumab prophylactically. This is the first case series to suggest that vedolizumab is an effective and well-tolerated therapeutic for steroid-dependent or partially refractory ICPI-induced enterocolitis. A larger prospective study to evaluate vedolizumab in this indication is warranted.
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| 4. |
- Berntorp, Erik, et al.
(författare)
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Treatment of haemophilia A and B and von Willebrand's disease : summary and conclusions of a systematic review as part of a Swedish health-technology assessment
- 2012
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Ingår i: Haemophilia. - : Wiley. - 1351-8216 .- 1365-2516. ; 18:2, s. 158-165
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Forskningsöversikt (refereegranskat)abstract
- In an ongoing health-technology assessment of haemophilia treatment in Sweden, performed by the governmental agency Dental and Pharmaceutical Benefits Agency (TLV; tandvårds-och läkemedelsförmånsverket), the Swedish Council on Health Technology Assessment (SBU; statens beredning för medicinsk utvärdering) was called upon to evaluate treatment of haemophilia A and B and von Willebrand's disease (VWD) with clotting factor concentrates. To evaluate the following questions: What are the short-term and long-term effects of different treatment strategies? What methods are available to treat haemophilia patients that have developed inhibitors against factor concentrates? Based on the questions addressed by the project, a systematic database search was conducted in PubMed, NHSEED, Cochrane Library, EMBASE and other relevant databases. The literature search covered all studies in the field published from 1985 up to the spring of 2010. In most instances, the scientific evidence is insufficient for the questions raised in the review. Concentrates of coagulation factors have good haemostatic effects on acute bleeding and surgical intervention in haemophilia A and B and VWD, but conclusions cannot be drawn about possible differences in the effects of different dosing strategies for acute bleeding and surgery. Prophylaxis initiated at a young age can prevent future joint damage in persons with haemophilia. The available treatment options for inhibitors have been insufficiently assessed. The economic consequences of various treatment regimens have been insufficiently analysed. Introduction of national and international registries is important.
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| 5. |
- Ekman, Simon, et al.
(författare)
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A novel oral insulin-like growth factor-1 receptor pathway modulator and its implications for patients with non-small cell lung carcinoma : A phase I clinical trial
- 2016
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Ingår i: Acta Oncologica. - 0284-186X .- 1651-226X. ; 55:2, s. 140-148
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: A phase Ia/b dose-escalation study was performed to characterize the safety, efficacy and pharmacokinetic properties of the oral small molecule insulin-like growth factor-1-receptor pathway modulator AXL1717 in patients with advanced solid tumors.MATERIAL AND METHODS: This was a prospective, single-armed, open label, dose-finding phase Ia/b study with the aim of single day dosing (phase Ia) to define the starting dose for multi-day dosing (phase Ib), and phase Ib to define and confirm recommended phase II dose (RP2D) and if possible maximum tolerated dose (MTD) for repeated dosing.RESULTS AND CONCLUSION: Phase Ia enrolled 16 patients and dose escalations up to 2900 mg BID were successfully performed without any dose limiting toxicity (DLT). A total of 39 patients were treated in phase Ib. AXL1717 was well tolerated with neutropenia as the only dose-related, reversible, DLT. RP2D dose was found to be 390 mg BID for four weeks. Some patients, mainly with NSCLC, demonstrated signs of clinical benefit, including four partial tumor responses (one according to RECIST and three according to PET). The 15 patients with NSCLC with treatment duration longer than two weeks with single agent AXL1717 in third or fourth line of therapy showed a median progression-free survival of 31 weeks and overall survival of 60 weeks. Down-regulation of IGF-1R on granulocytes and increases of free serum levels of IGF-1 were seen in patients treated with AXL1717. AXL1717 had an acceptable safety profile and demonstrated promising efficacy in this heavily pretreated patient cohort, especially in patients with NSCLC. RP2D was concluded to be 390 mg BID for four weeks. Trial number is NCT01062620.
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| 6. |
- Ekman, Simon, et al.
(författare)
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Clinical Phase I study with an Insulin-like Growth Factor-1 Receptor Inhibitor : Experiences in patients with squamous non-small cell lung carcinoma
- 2011
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Ingår i: Acta Oncologica. - 0284-186X .- 1651-226X. ; 50:3, s. 441-447
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Tidskriftsartikel (refereegranskat)abstract
- Background. Inhibition of the Insulin-like Growth Factor-1 receptor (IGF-1R) has resulted in extensive anti-tumor effects. Picropdophyllin (PPP, AXL1717) is a small-molecule inhibitor of the IGF-1R without inhibition of closely related receptors including the insulin receptor and has shown extensive effects against a wide range of tumors in animals. PPP is currently tested as an orally administrated single agent treatment in an open-label combined Phase I/II clinical study in advanced cancer patients with solid tumors which progress in spite of several lines of treatment. Patients and methods. The first part (Phase IA) consisted of single day BID dosing every three weeks with consecutive dose escalations. The second part (Phase IB) consists of seven days or longer BID dosing every three weeks, dosing range being 520-700 mg BID. Non-progressing patients could continue treatment within a compassionate use setting. Results and discussion. The present report describes our experience with the four patients with progressive squamous non-small cell lung cancer (NSCLC) that have received treatment with PPP. Despite more than seven months of PPP treatment as third or fourth line treatment, the reported patients did not develop any additional metastases. Furthermore, CT scans as well as (18)FDG-Positron Emission Tomography (PET) scans of the patients demonstrated large central necrotic areas, which may suggest tumor response. At the same time, the study drug is so far well tolerated. The phenomenon of necrosis in the tumors suggestive of tumor response has not been reported before in anti-IGF-1R treatment and will be subject to further studies in the present clinical trial.
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| 7. |
- Engström, Tomas, 1950, et al.
(författare)
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Brukarmedverkan vid planering-, bygg- och förvaltningsprocesser inom högskoleväsendet - Några erfarenheter, paralleller och reflektioner
- 2001
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Ingår i: Arbete människa miljö. - 1402-859X. ; :1, s. 41 - 61
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Tidskriftsartikel (refereegranskat)abstract
- Here in this publication are we criticizing the way the building facilities are managed at Chalmers University of Technology as well at Lund University (in fact a number of extremely long term failures to deal with building facilities in appropriate ways required at Chalmers have affected Engström’s and his research group members, two of these have been evaluated by external competencies) (besides, a visit to Chalmers even today will most certainly still underline this particular situation, i.e. at least for the trained eye familiar with public buildings and science demands) (similar situation is as reported also at hand elsewhere) (extreme rents for building facilities, are today signifying the operation at this and other universities).
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| 8. |
- Engström, Tomas, 1950, et al.
(författare)
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Guidelines for Coupling of the Building Facilities to the External and Internal Demands Generated by the Society
- 2001
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Here in this publication are we criticizing the way the building facilities are managed at e.g. Chalmers University of Technology (in fact a number of extremely long term failures to deal with building facilities in appropriate ways required at Chalmers have affected Engström’s and his research group members, two of these have been evaluated by external competencies) (besides, a visit to Chalmers even today will most certainly still underline this particular situation, i.e. at least for the trained eye familiar with public buildings and science demands) (similar situation is as reported also at hand elsewhere) (extreme rents for building facilities, are today signifying the operation at this and other universities).
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| 9. |
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| 10. |
- Engström, Tomas, 1950, et al.
(författare)
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Linking of User (Tenant) Demands to the (Physical) Building Facility
- 2003
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Ingår i: Technology, health care, and management in the hospital of the future / edited by Eliezer Geisler, Koos Krabbendam, Roel Schuring. ; , s. 179-197
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Bokkapitel (övrigt vetenskapligt/konstnärligt)abstract
- This book chapter treats certain parallels between health-care services and the three authors' experiences and insights from the automotive and manufacturing industry, as well as from dealing with public enterprises. Especially so with regard to the building facilities, and how such facilities are managed within the automotive industry and the university. Thereby drawing some more general and particular conclusion on how this ought to inflict hospital designs.
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