Letter to the Editor
Comment on “Drug survival analysis is not a good method for assessing the safety or effectiveness of systemic therapies in psoriasis”
Réplica a: “El análisis de supervivencia no es un buen método para evaluar la seguridad o la efectividad de los tratamientos sistémicos en psoriasis”
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Kievit, E.M.G.J. de Jong" "autores" => array:3 [ 0 => array:4 [ "nombre" => "J.M.P.A." "apellidos" => "van den Reek" "email" => array:1 [ 0 => "Juul.vandenReek@Radboudumc.nl" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "W." "apellidos" => "Kievit" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "E.M.G.J." "apellidos" => "de Jong" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Department of Dermatology, Radboud University Medical Center, Nijmegen, The Netherlands" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Department of Health Evidence, Radboud Institute of Health Sciences, Nijmegen, The Netherlands" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Radboud University, Nijmegen, The Netherlands" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Réplica a: “El análisis de supervivencia no es un buen método para evaluar la seguridad o la efectividad de los tratamientos sistémicos en psoriasis”" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">We read with great interest the article “Drug survival analysis is not a good method for assessing the safety or effectiveness of systemic therapies in psoriasis” by Davila-Seijo and Garcia-Doval.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">1</span></a> In the article, the authors explain that drug survival studies are not a good way to evaluate the safety or effectiveness of psoriasis treatments because biases can seriously affect the interpretation of drug survival data. We agree with this statement but would like to add that drug survival should be regarded as regarded as a different entity than a mere effectiveness or safety outcome, and that it should be complementary to those outcomes. Drug survival is a comprehensive measure that <span class="elsevierStyleItalic">incorporates</span> effectiveness and safety as well as the preferences of both patients and doctors. Drug survival data can easily be split for the reason for the discontinuation (e.g., ineffectiveness or adverse effects) to provide more detailed information.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">2</span></a> This does not mean that drug survival directly measures the rate of adverse effects or the precise effectiveness of a drug. However, it does provide important information, including the following: (1) which adverse effects or level of ineffectiveness are considered unacceptable by the doctor and patient; (2) when do adverse effects or (in)effectiveness occur; and (3) which variables predict a sustained and successful response to a drug.</p><p id="par0010" class="elsevierStylePara elsevierViewall">One of the author's main points is that drug survival is particularly inappropriate for the comparison of drugs. However, we would like to point out that, irrespective of the outcome (drug survival or disease activity), a control group is actually needed for comparative effectiveness studies. In an observational setting, confounding by (contra)indication often plays a role in this context and is indeed problematic. We believe that the real problem in these comparative effectiveness studies the authors are referring to is not the use of drug survival as an outcome, but the lack of a control group or the lack of confounder correction in observational studies.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The authors also describe certain biases that may occur in drug survival studies. Fortunately, there are solutions that minimize the impact of most biases, as we have described in the <span class="elsevierStyleItalic">Journal of Investigative Dermatology</span>.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">3</span></a> Dávila-Seijo and García-Doval mention that the authors of many studies fail to report how the end of treatment was defined, and that defining withdrawal on the basis of the loss of one or several doses could lead to problems when studying drugs with long dosing intervals. This problem can be solved in part by defining discontinuation as withdrawal of the treatment for a period of more than 90 days; this is an arbitrary but widely accepted threshold.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">2</span></a> The statement that ustekinumab should be stopped 24 weeks before it can be considered to have been discontinued does not seem valid to us. We dealt with this problem differently, analyzing cases of ustekinumab in which therapy had been stopped for more than 90 days with sensitivity analyses, considering the last injection date as well as the last injection date plus the specific treatment interval for each case (often 12 weeks) as the possible dates of discontinuation.<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">3,4</span></a> The authors state that intermittent therapy poses a problem in drug survival. We, however, think that patients on intermittent therapy should not be investigated using this method because the research question in drug survival studies refers to long-term use of treatment for chronic disease. To our knowledge, hardly any articles on drug survival focus on intermittent therapy. Analyzing positive events, such as disease remission, is also considered a problem. Positive events can be analyzed when the distinction between negative and positive events is maintained at all times and the reader is made aware of this important distinction.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">3</span></a> If a drug can be discontinued due to both positive (e.g. remission) and negative (e.g. ineffectiveness) events, one can censor the positive events when one is only interested in the negative events and vice versa.</p><p id="par0020" class="elsevierStylePara elsevierViewall">We agree that drug survival can be influenced by external factors, such as changes in reimbursement criteria or the introduction of new biologics. One solution to this problem is to restrict analyses to specific time periods.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">3</span></a> For instance, in a drug survival study (adalimumab, etanercept, ustekinumab), we chose to analyze only treatment episodes that started after the introduction of ustekinumab, thereby minimizing the competing risks.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">4</span></a> Events that lead to withdrawal of an agent do indeed differ between prescribers and patients. Therefore, a large, heterogeneous group of prescribers and patients should be evaluated; offering a general view of what patients and doctors accept from a drug in terms of safety issues and ineffectiveness. It has been shown that large psoriasis drug survival studies with a heterogeneous group of patients and prescribers reported similar findings overall.<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">5–7</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">To answer the question asked by these authors—“Is it really important which treatments survive longer?”— we do think that drug survival is a suitable measure for analyzing the performance of a drug in daily practice, provided the necessary steps are taken to minimize bias.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">3</span></a> However, drug survival should not be regarded as a sole outcome measure for effectiveness or safety. It is important to use a combination of several different outcomes, each one with its specific biases, to fully judge the performance of a drug.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflict of interest</span><p id="par0030" class="elsevierStylePara elsevierViewall">J.M.P.A. van den Reek performed clinical trials for AbbVie and Janssen. J.M.P.A. van den Reek has received speaking fees from AbbVie and Eli Lilly and reimbursement for attending a symposium from Janssen, Pfizer, and AbbVie. Fees were paid directly to the institution.</p><p id="par0035" class="elsevierStylePara elsevierViewall">E.M.G.J. de Jong has received grants for the independent research fund of the department of dermatology of Radboud university medical centre in Nijmegen from AbbVie, Pfizer, and Janssen. She has acted as consultant and/or paid speaker for and/or participated in research sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Janssen, MSD, Pfizer, Novartis, Lily, Amgen, and Cellgene. The resources obtained are not received personally but are paid to the independent research fund of the department of dermatology of Radboud university medical centre in Nijmegen in the Netherlands.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflict of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:7 [ 0 => array:3 [ "identificador" => "bib0040" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Drug survival analysis is not a good method for assessing the safety or effectiveness of systemic therapies in psoriasis" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "P. 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| año/Mes | Html | Total | |
|---|---|---|---|
| 2024 Noviembre | 8 | 13 | 21 |
| 2024 Octubre | 53 | 40 | 93 |
| 2024 Septiembre | 51 | 27 | 78 |
| 2024 Agosto | 75 | 48 | 123 |
| 2024 Julio | 52 | 28 | 80 |
| 2024 Junio | 43 | 25 | 68 |
| 2024 Mayo | 41 | 27 | 68 |
| 2024 Abril | 57 | 21 | 78 |
| 2024 Marzo | 39 | 23 | 62 |
| 2024 Febrero | 42 | 30 | 72 |
| 2024 Enero | 31 | 29 | 60 |
| 2023 Diciembre | 42 | 14 | 56 |
| 2023 Noviembre | 52 | 26 | 78 |
| 2023 Octubre | 40 | 18 | 58 |
| 2023 Septiembre | 38 | 30 | 68 |
| 2023 Agosto | 42 | 9 | 51 |
| 2023 Julio | 34 | 33 | 67 |
| 2023 Junio | 48 | 23 | 71 |
| 2023 Mayo | 44 | 20 | 64 |
| 2023 Abril | 35 | 23 | 58 |
| 2023 Marzo | 44 | 25 | 69 |
| 2023 Febrero | 48 | 22 | 70 |
| 2023 Enero | 27 | 23 | 50 |
| 2022 Diciembre | 46 | 24 | 70 |
| 2022 Noviembre | 30 | 40 | 70 |
| 2022 Octubre | 50 | 32 | 82 |
| 2022 Septiembre | 41 | 36 | 77 |
| 2022 Agosto | 35 | 43 | 78 |
| 2022 Julio | 36 | 49 | 85 |
| 2022 Junio | 20 | 28 | 48 |
| 2022 Mayo | 32 | 46 | 78 |
| 2022 Abril | 23 | 38 | 61 |
| 2022 Marzo | 40 | 44 | 84 |
| 2022 Febrero | 34 | 28 | 62 |
| 2022 Enero | 33 | 43 | 76 |
| 2021 Diciembre | 36 | 41 | 77 |
| 2021 Noviembre | 39 | 42 | 81 |
| 2021 Octubre | 86 | 65 | 151 |
| 2021 Septiembre | 41 | 31 | 72 |
| 2021 Agosto | 34 | 34 | 68 |
| 2021 Julio | 30 | 36 | 66 |
| 2021 Junio | 24 | 33 | 57 |
| 2021 Mayo | 33 | 43 | 76 |
| 2021 Abril | 52 | 61 | 113 |
| 2021 Marzo | 55 | 36 | 91 |
| 2021 Febrero | 40 | 26 | 66 |
| 2021 Enero | 38 | 26 | 64 |
| 2020 Diciembre | 24 | 18 | 42 |
| 2020 Noviembre | 30 | 26 | 56 |
| 2020 Octubre | 29 | 22 | 51 |
| 2020 Septiembre | 37 | 19 | 56 |
| 2020 Agosto | 28 | 26 | 54 |
| 2020 Julio | 22 | 21 | 43 |
| 2020 Junio | 29 | 33 | 62 |
| 2020 Mayo | 14 | 15 | 29 |
| 2020 Abril | 18 | 20 | 38 |
| 2020 Marzo | 26 | 16 | 42 |
| 2020 Febrero | 5 | 2 | 7 |
| 2019 Diciembre | 4 | 0 | 4 |
| 2019 Septiembre | 4 | 0 | 4 |
| 2019 Mayo | 3 | 0 | 3 |
| 2019 Abril | 3 | 0 | 3 |
| 2019 Febrero | 2 | 0 | 2 |
| 2018 Diciembre | 5 | 0 | 5 |
| 2018 Noviembre | 4 | 0 | 4 |
| 2018 Octubre | 1 | 0 | 1 |
| 2018 Septiembre | 5 | 0 | 5 |
| 2018 Mayo | 1 | 0 | 1 |
| 2018 Abril | 0 | 3 | 3 |
| 2018 Febrero | 7 | 5 | 12 |
| 2018 Enero | 11 | 7 | 18 |
| 2017 Diciembre | 9 | 9 | 18 |
| 2017 Noviembre | 13 | 11 | 24 |
| 2017 Octubre | 9 | 9 | 18 |
| 2017 Septiembre | 20 | 54 | 74 |
| 2017 Agosto | 3 | 27 | 30 |
| 2017 Julio | 0 | 11 | 11 |
| 2017 Junio | 0 | 17 | 17 |
| 2017 Mayo | 0 | 15 | 15 |
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