Abstract:Despite necessary monthly visits, patients showed a high adherence to therapy. The major problem was travel to and from the hospital. From the patients' point of view, anxiety of a negative examination result was more pronounced than fear of intraocular injections, which would be an argument for continuous injections rather than for a PRN regimen.
“…Of note, the anxiety surrounding the receipt of negative eye examination results has been reported to be more pronounced than that of receiving intravitreal injection 25. Consequently, patients may be more likely to comply with a TE regimen where the likelihood of an injection during a clinic visit is known and understood, than with a PRN regimen.…”
A TE regimen can improve and stabilise patient outcomes in nAMD compared with PRN, with the potential to reduce the healthcare resource burden incurred from fixed monitoring requirements.
“…Of note, the anxiety surrounding the receipt of negative eye examination results has been reported to be more pronounced than that of receiving intravitreal injection 25. Consequently, patients may be more likely to comply with a TE regimen where the likelihood of an injection during a clinic visit is known and understood, than with a PRN regimen.…”
A TE regimen can improve and stabilise patient outcomes in nAMD compared with PRN, with the potential to reduce the healthcare resource burden incurred from fixed monitoring requirements.
“…This approach reduces the frequency of clinic visits and removes the requirement for interim monitoring between injections, which helps to make the disease more manageable for the patient and physician while still ensuring that an appropriate number of injections are administered. This may also reduce the anxiety experienced by patients who fear disease recurrence, as well as any uncertainty regarding whether they will receive an injection at their forthcoming appointment [61]. The psychological and physical impact of any treatment regimen on patients is a factor that should always be considered.Fig.…”
BackgroundIntravitreal anti–vascular endothelial growth factor (VEGF) therapy is now considered the gold standard for the treatment of various retinal disorders. As therapy has evolved, so too have the treatment regimens employed by physicians in clinical practice; however, visual outcomes observed in the real world have typically not reflected those reported in clinical trials. Possible reasons for this include a lack of consensus on treatment regimens and a lack of clarity about what the aims of treatment should be.MethodsThe Vision Academy Steering Committee met to discuss the principles of an ideal treatment regimen, using evidence from the literature to substantiate each point. Literature searches were performed using the MEDLINE/PubMed database (cut-off date: March 2016) and restricted to English-language publications. Studies with fewer than ten patients were excluded from this review.ResultsThe Steering Committee identified the following four key principles for the ideal treatment regimen for anti-VEGF management of retinal diseases:Maximize and maintain visual acuity (VA) benefits for all patientsDecide when to treat next, rather than whether to treat nowTitrate the treatment intervals to match patients’ needsTreat at each monitoring visit.
ConclusionsIt is proposed that the adoption of a proactive and more personalized approach in the clinic such as a treat-and-extend regimen will lead to benefits for both the patient and the physician, through a reduction in the associated treatment burden and better utilization of clinic resources. Implementation of the four principles should also lead to better VA outcomes for each patient, with a minimized risk of vision loss.
“…A T&E regimen administered as a one-stop clinic service may also reduce patients’ anxiety regarding receiving injections [24, 25], as the likelihood of an injection is already known and understood, which is in contrast to the PRN regimen; however, this may vary from patient to patient and, conversely, those on a PRN regimen may have a sense of hope that they will not receive an injection, compared with a T&E regimen in which they know they will always be treated. Nevertheless, the T&E regimen represents an individualised treatment approach, ensuring that patients receive injections at the frequency most appropriate to their disease status [12].…”
IntroductionRanibizumab is an inhibitor of vascular endothelial growth factor-A (anti-VEGF) approved for the treatment of neovascular age-related macular degeneration (nAMD). The treat and extend (T&E) regimen can potentially reduce the burden of clinic visits compared with a pro re nata (PRN) regimen. Retrospective, interim analyses of clinical effectiveness, treatment and resource use patterns were conducted using real-world data in England and Wales from the TERRA study.MethodsTwo cohorts, those switching from a PRN to a T&E regimen (‘prior PRN’) and those initiating ranibizumab on the T&E regimen as their first anti-VEGF therapy (‘anti-VEGF-naïve’) were enrolled in TERRA. Retrospective clinical assessments were gathered from medical records, while resource use patterns were collected via an operating cost questionnaire completed by each study site.ResultsAt the interim analysis cut-off date (15 November 2016), 11 sites had enrolled 145 patients (prior PRN: n = 110; anti-VEGF-naïve: n = 35). Mean change from baseline (date of first injection) in visual acuity and central subfield retinal thickness to 12 months was +7.6 Early Treatment Diabetic Retinopathy Study letters [95% confidence interval (CI) 2.8, 12.4; p = 0.003; n = 27] and −67.7 μm (95% CI −106.5, −28.9; p = 0.001, n = 29), respectively, in the anti-VEGF-naïve cohort. Most T&E clinics were run as one-stop services (same-day monitoring and injection), whereas 4/10 PRN clinics were run as two-stop services (monitoring and injection on different days). In general, one-stop clinics used less staff resources and were likely to be shorter in duration for healthcare providers than the cumulative time spent for two-stop clinics.ConclusionThis is the first real-world observational study conducted in England and Wales demonstrating the effectiveness of the ranibizumab T&E regimen in anti-VEGF-naïve patients. T&E is compatible with one-stop clinic services, which these real-world data suggest to be less resource intensive than two-stop clinic services, possibly providing a dosing regimen beneficial to both patients and resource burden in UK clinical practice.
Funding: Novartis Pharmaceuticals UK Limited.Electronic supplementary materialThe online version of this article (doi:10.1007/s40123-017-0091-9) contains supplementary material, which is available to authorized users.
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