| 1. |
- Calara, Paul S., et al.
(författare)
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Healthcare Provider Type and Switch to Biologics in Psoriasis : Evidence from Real-World Practice
- 2016
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Ingår i: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy. - : Springer Science and Business Media LLC. - 1173-8804 .- 1179-190X. ; 30:2, s. 145-151
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Previous research indicates an uneven uptake of biologics in patients with moderate-to-severe psoriasis in Sweden. Therefore, it is essential to scrutinise variations in treatment patterns.OBJECTIVE: The aim of this study was to evaluate the extent to which the uptake of biologics for psoriasis differs between types of healthcare provider.METHODS: Three types of provider were identified within 52 units participating in the Swedish National Registry for Systemic Psoriasis Treatment (PsoReg): university hospitals, non-university hospitals and individual practices. Biologics-naïve patients (n = 3165) were included in analyses to investigate the probability of switch to biologics. The numbers of patients fulfilling the criteria for moderate-to-severe psoriasis [Psoriasis Area and Severity Index (PASI) ≥10 and Dermatology Life Quality Index (DLQI) ≥10] among patients who switched to biologics and patients who did not switch were reported. A logistic regression model was used to calculate how healthcare provider type influenced the probability of switch to biologics whilst adjusting for patient characteristics and disease severity.RESULTS: During registration, 16 % of patients switched to biologics while 84 % remained on conventional systemic treatment. In 7 % of patients, the criteria PASI ≥10 and DLQI ≥10 was fulfilled at their last visit without switching to biologics, whereas in 10 % of patients the criteria was not fulfilled prior to switch. After controlling for patient characteristics and disease severity, small or no difference in the probability of switch was observed between provider types.CONCLUSIONS: Disease severity does not explain the decision to switch or not to switch to biologics for a disproportionate number of patients. There seems to be an uneven uptake of biologics in Swedish clinical practice, but the type of healthcare provider cannot explain this variation. More research is needed on what factors influence the prescription of biologics.
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| 2. |
- Calara, Paul S, et al.
(författare)
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Regional Differences in the Prescription of Biologics for Psoriasis in Sweden : a Register-Based Study of 4168 Patients
- 2017
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Ingår i: BioDrugs. - : Springer Science and Business Media LLC. - 1173-8804 .- 1179-190X. ; 31:1, s. 75-82
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Observational studies suggest an inequitable prescription of biologics in psoriasis care, which may be attributed to geographical differences in treatment access. Sweden regularly ranks high in international comparisons of equitable healthcare, and is, in connection with established national registries, an ideal country to investigate potential inequitable access.OBJECTIVE: The aim was to determine whether the opportunity for patients to receive biologics depends on where they receive care.METHODS: Biologic-naïve patients enrolled in the Swedish National Register for Systemic Treatment of Psoriasis (PsoReg) from 2008 to 2015 (n = 4168) were included. The association between the likelihood of initiating a biologic and the region where patients received care was analyzed. The strength of the association was adjusted for patient and clinical characteristics, as well as disease severity using logistic regression analysis. The proportion of patients that switched to a biologic (switch rate) and the probability of switch to a biologic was calculated in 2-year periods.RESULTS: The national switch rate increased marginally over time from 9.7 to 11.0%, though the uptake varied across regions. Adjusted odds ratios for at least one region were significantly different from the reference region in every 2-year period. During the latest period (2014-2015), the average patient in the lowest prescribing region was nearly 2.5 times less likely to switch as a similar patient in the highest prescribing region.CONCLUSIONS: Geographical differences in biologics prescription persist after adjusting for patient characteristics and disease severity. The Swedish example calls for further improvements in delivering equitable psoriasis care.
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| 3. |
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| 4. |
- Druedahl, Louise C., et al.
(författare)
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Evolving Biosimilar Clinical Requirements : A Qualitative Interview Study with Industry Experts and European National Medicines Agency Regulators
- 2021
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Ingår i: BioDrugs. - : ADIS INT LTD. - 1173-8804 .- 1179-190X. ; 35:3, s. 351-361
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Tidskriftsartikel (refereegranskat)abstract
- Background A biosimilar is a biological medicine highly similar to another already approved biological medicine (reference product). The availability of biosimilars promotes competition and subsequently lower prices. Changing the current biosimilar clinical comparability trial requirements may lead to lower biosimilar development costs that potentially could increase patients' access to biologics. Objective The aim was to determine the perceptions of industry and medicines agency regulators regarding the value, necessity, and future developments of the European biosimilar clinical comparability trial requirements for establishing biosimilarity. Methods Semi-structured interviews were conducted with eight European national medicines agency regulators and 17 pharmaceutical company employees or consultants with experience in biologics between September 2018 and August 2019. Data were subjected to content analysis. Results In general, the participants expected that clinical comparability trial requirements will continue to be reduced, in particular based on advancements in analytical testing and knowledge generated from prior biosimilar approvals. However, there are also competing issues at play, such as competition, physician's trust, and ethical considerations. Participants also reported that any new initiative to reduce or waive biosimilar clinical requirements needs to be scientifically sound and could potentially lower biosimilar development costs. Conclusion The main findings are that biosimilar clinical comparability trial requirements are likely to change in the near future. Clarity is needed on how to ensure adequate correlation between physicochemical data, pharmacokinetic/pharmacodynamic studies, and the drugs' performance in the clinic, as well as how to continue sufficient immunogenicity assessment. Obtaining this clarity can facilitate regulatory assessment of the next biosimilars.
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| 5. |
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| 6. |
- Hillerdal, Victoria, et al.
(författare)
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Chimeric Antigen Receptor-Engineered T Cells for the Treatment of Metastatic Prostate Cancer
- 2015
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Ingår i: BioDrugs. - : Springer Science and Business Media LLC. - 1173-8804 .- 1179-190X. ; 29:2, s. 75-89
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Tidskriftsartikel (refereegranskat)abstract
- Cancer immunotherapy was selected as the Breakthrough of the Year 2013 by the editors of Science, in part because of the successful treatment of refractory hematological malignancies with adoptive transfer of chimeric antigen receptor (CAR)-engineered T cells. Effective treatment of B cell leukemia may pave the road to future treatment of solid tumors, using similar approaches. The prostate expresses many unique proteins and, since the prostate gland is a dispensable organ, CAR T cells can potentially be used to target these tissue-specific antigens. However, the location and composition of prostate cancer metastases complicate the task of treating these tumors. It is therefore likely that more sophisticated CAR T cell approaches are going to be required for prostate metastasis than for B cell malignancies. Two main challenges that need to be resolved are how to increase the migration and infiltration of CAR T cells into prostate cancer bone metastases and how to counteract the immunosuppressive microenvironment found in bone lesions. Inclusion of homing (chemokine) receptors in CAR T cells may improve their recruitment to bone metastases, as may antibody-based combination therapies to normalize the tumor vasculature. Optimal activation of CAR T cells through the introduction of multiple costimulatory domains would help to overcome inhibitory signals from the tumor microenvironment. Likewise, combination therapy with checkpoint inhibitors that can reduce tumor immunosuppression may help improve efficacy. Other elegant approaches such as induced expression of immune stimulatory cytokines upon target recognition may also help to recruit other effector immune cells to metastatic sites. Although toxicities are difficult to predict in prostate cancer, severe on-target/offtumor toxicities have been observed in clinical trials with use of CAR T cells against hematological malignancies; therefore, the choice of the target antigen is going to be crucial. This review focuses on different means of accomplishing maximal effectiveness of CAR T cell therapy for prostate cancer bone metastases while minimizing side effects and CAR T cell-associated toxicities. CAR T cell-based therapies for prostate cancer have the potential to be a therapy model for other solid tumors.
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| 7. |
- Johansson, J, et al.
(författare)
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Pulmonary surfactant: emerging protein analogues
- 1999
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Ingår i: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy. - : Springer Science and Business Media LLC. - 1173-8804. ; 11:2, s. 71-77
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Tidskriftsartikel (refereegranskat)
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| 8. |
- Kristensen, Lars Erik, et al.
(författare)
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Non-pharmacological Effects in Switching Medication : The Nocebo Effect in Switching from Originator to Biosimilar Agent
- 2018
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Ingår i: BioDrugs. - : Springer Science and Business Media LLC. - 1173-8804 .- 1179-190X. ; 32:5, s. 397-404
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Tidskriftsartikel (refereegranskat)abstract
- The nocebo effect is defined as the incitement or the worsening of symptoms induced by any negative attitude from non-pharmacological therapeutic intervention, sham, or active therapies. When a patient anticipates a negative effect associated with an intervention, medication or change in medication, they may then experience either an increase in this effect or experience it de novo. Although less is known about the nocebo effect compared with the placebo effect, widespread interest in the nocebo effect observed with statin therapy and a literature review highlighting the nocebo effect across at least ten different disease areas strongly suggests this is a common phenomenon. This effect has also recently been shown to play a role when introducing a medication or changing an established medication, for example, when switching patients from a reference biologic to a biosimilar. Given the important role biosimilars play in providing cost-effective alternatives to reference biologics, increasing physician treatment options and patient access to effective biologic treatment, it is important that we understand this phenomenon and aim to reduce this effect when possible. In this paper, we propose three key strategies to help mitigate the nocebo effect in clinical practice when switching patients from reference biologic to biosimilar: positive framing, increasing patient and healthcare professionals’ understanding of biosimilars and utilising a managed switching programme.
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| 9. |
- Lubenow, Norbert, et al.
(författare)
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Heparin-induced thrombocytopenia : recommendations for optimal use of recombinant hirudin.
- 2000
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Ingår i: BioDrugs. - 1173-8804 .- 1179-190X. ; 14:2, s. 109-25
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Tidskriftsartikel (refereegranskat)abstract
- Recombinant hirudins have a definite role in the treatment of patients with heparin-induced thrombocytopenia (HIT). The most important adverse effects are haemorrhages and the induction of antihirudin antibodies. Major haemorrhages were not significantly increased in patients with HIT compared with a historical control group, but prospective data comparing hirudin and heparinoids such as danaparoid are lacking. The definition of the optimal method for monitoring and the availability of an antidote for hirudin would probably increase safety with this drug. To date, haemofiltration using high-flux filter systems is the only way to remove an overdosage of hirudin from the circulation. In patients with renal impairment requiring hirudin treatment, it therefore seems safer to start with a low dose that is subsequently adjusted according to the activated partial prothromboplastin time or ecarin clotting time. Even in special circumstances, such as cardiopulmonary bypass or dialysis, hirudins can be applied successfully if care is taken to monitor their effects meticulously. There are many other indications in which hirudins have shown feasibility (e.g. acute coronary syndromes) but available data preclude definite conclusions.
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| 10. |
- Lötvall, Jan, 1956, et al.
(författare)
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Targeting drugs to the airways by different inhalation devices: role of deposition characteristics.
- 1999
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Ingår i: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy. - 1173-8804. ; 12:4, s. 279-89
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Tidskriftsartikel (refereegranskat)abstract
- Inhalation therapy has greatly improved the treatment of asthma over the last decades. In recent years, inhalation technology has further optimised the local deposition of inhaled antiasthma drugs. Some studies have suggested improved clinical efficacy, and possibly tolerability, of drugs given with modern dry powder inhalers. In particular, the inhalers Turbuhaler((R)) and Diskus((R)) are now commonly used to treat asthma. This review critically evaluates studies comparing the clinical efficacy of antiasthma drugs delivered by available powder inhalers or by pressurised metered-dose inhalers (pMDI), focusing on comparisons of the same drug given by different inhalers. Results differ among studies, in part because of the inclusion of different patient groups (ideally the patients should have reversible airways obstruction) and use of unequal doses or artificial inhalation patterns that may not be optimal for one of the devices. Furthermore, the use of plastic spacers with pMDIs may affect drug delivery.
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