Letter to the Editor
Impact of the Thickness of the Subcutaneous Tissue at the Site of Injection as Measured by Ultrasound on the Therapeutic Response to Subcutaneous anti-Tumour Necrosis Factor Drugs
Impacto del grosor del tejido celular subcutáneo en el sitio de la inyección medido por ecografía sobre la respuesta terapéutica a fármacos antifactor de necrosis tumoral subcutáneos
Tamara del Río
, Lara Valor, Inmaculada de la Torre, Esperanza Naredo
Corresponding author
Departamento de Reumatología, Hospital General Universitario Gregorio Marañón, Madrid, Spain
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Valor, Inmaculada de la Torre, Esperanza Naredo" "autores" => array:4 [ 0 => array:4 [ "nombre" => "Tamara" "apellidos" => "del Río" "email" => array:1 [ 0 => "t.delrioblasco@hotmail.com" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "Lara" "apellidos" => "Valor" ] 2 => array:2 [ "nombre" => "Inmaculada" "apellidos" => "de la Torre" ] 3 => array:2 [ "nombre" => "Esperanza" "apellidos" => "Naredo" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Departamento de Reumatología, Hospital General Universitario Gregorio Marañón, Madrid, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Impacto del grosor del tejido celular subcutáneo en el sitio de la inyección medido por ecografía sobre la respuesta terapéutica a fármacos antifactor de necrosis tumoral subcutáneos" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1125 "Ancho" => 3250 "Tamanyo" => 375382 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Ultrasound images of subcutaneous tissue. (A) Right arm. (B) Right abdomen. (C) Right thigh.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Biologic therapies with tumor necrosis factor (TNF)-α inhibitors are widely used to treat inflammatory diseases, such as rheumatoid arthritis (RA) and spondyloarthropathies (SpA).<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> They are administered subcutaneously (SC) or intravenously (IV), and the route has an influence on their bioavailability. In SC administration, there are 2 aspects to consider: the site and the injection technique,<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">2–5</span></a> both of which are key factors in the proper administration of the injections; thus, training of patients by the nursing staff is essential for SC self-administration of anti-TNF agents.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The thickness of the subcutaneous tissue (ST) can influence the proper distribution of the drugs throughout the organism. This thickness can be affected by age, sex and body mass index (BMI),<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">2,4–6</span></a> variables that are important for the determination of the administration site and technique for each patient. In the case of insulin-dependent diabetes mellitus, the needles for self-administration devices are available in a wide variety of lengths, depending on the ST thickness, as has been reported previously in a number of publications. However, there are no studies on this subject dealing with rheumatic diseases treated by SC administration of anti-TNF agents. The proper injection technique ensures that the SC anti-TNF agent be injected into ST, rather than intramuscular (IM) or intradermal tissue.</p><p id="par0015" class="elsevierStylePara elsevierViewall">This prospective cross-sectional observational study involved 117 patients with RA (n=59) or SpA (n=58) being treated with an anti-TNF agent that the patients administered SC to themselves for a minimum of 6 months. The thickness of the ST was measured in all the patients at the sites recommended for SC injection (arms, abdomen, thighs), regardless of the preferred site for self-administration, using gray-scale ultrasound (ultrasound system equipped with a 6–18-MHz multifrequency linear transducer). Ultrasound measurement of the ST was always performed using the same method and with the patient in the sitting position. Gel was applied between the probe and the skin to avoid putting pressure on the ST with the probe (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>). The probe was placed transversely and longitudinally, on the right and left sides, at the sites recommended for SC injection. We then calculated the average between the two measurements.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">The results are expressed as the mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>standard deviation (SD) for continuous variables and as absolute frequencies and percentages for categorical variables. The continuous variables in independent groups were compared using the independent samples <span class="elsevierStyleItalic">t</span>-test when 2 groups were involved. For the comparison of 3 groups, we used 1-way analysis of variance (ANOVA) with the Tukey test, or the Kruskal–Wallis test with the Mann–Whitney test and the Bonferroni correction to determine the unpaired samples, depending on the assumption or rejection, respectively, of the null hypothesis. The linear relationship between independent variables was established by means of the Pearson correlation coefficient. Fisher's exact test of independence for categorical variables was applied in the case of 2 dichotomous variables, and the chi-squared test when any of the variables had more than 2 categories. Logistic models were developed as dichotomous outcomes of clinical remission or no clinical remission, according to the Disease Activity Score for 28 joints (DAS28) and C-reactive protein (CRP) level. We analyzed age, BMI, ST thickness in abdomen, arms and thighs, time since diagnosis, time since initiation of anti-TNF therapy (with etanercept, adalimumab, others [because of the small sample size, patients treated with golimumab and certolizumab pegol were analyzed jointly]), and concomitant treatment with disease-modifying antirheumatic drugs. The odds ratio was calculated with its 95% confidence interval). <span class="elsevierStyleItalic">P</span> values ≤.05 were considered to indicate significance. The statistical analyses were performed with the SPSS statistical software package (v15.0).</p><p id="par0025" class="elsevierStylePara elsevierViewall">Due to the small sample size, our RA and SpA patients were analyzed jointly, according to the anti-TNF agent utilized. Fifty-nine patients (50.5%) had been diagnosed with RA and 58 (49.5%) with SpA. Fifty-six patients (47.9%) were receiving etanercept; 52 (44.4%), adalimumab; 7 (6%), golimumab; and 2 (1.7%), certolizumab pegol. Eighty-two (70%) self-administered the anti-TNF agent in abdomen, 23 (19.7%) in thigh and 12 (10.3%) in arm.</p><p id="par0030" class="elsevierStylePara elsevierViewall">The majority of the patients were women (n=61, 52.1%). The mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>SD (range) for the variables were as follows: age, 52.77<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>13.28 (24–82) years; weight, 74.01<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>15.19 (46–125)<span class="elsevierStyleHsp" style=""></span>kg; height, 1.65<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>0.08 (1.43–1.84)<span class="elsevierStyleHsp" style=""></span>m; and BMI, 27<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>4.75 (18.44–41.58)<span class="elsevierStyleHsp" style=""></span>kg/m<span class="elsevierStyleSup">2</span>. The clinical response to the anti-TNF agent was evaluated using the following remission or activity criteria: DAS28 and CRP for the patients with RA and the Ankylosing Spondylitis Disease Activity Score (ASDAS) for the patients with SpA. In RA, remission was considered to be indicated by a DAS28<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>2.6 and no remission by a DAS28<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>2.6, and remission in SpA by an ASDAS<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>1.3 and no remission by an ASDAS<span class="elsevierStyleHsp" style=""></span>≥<span class="elsevierStyleHsp" style=""></span>1.3.</p><p id="par0035" class="elsevierStylePara elsevierViewall">The mean thickness of the ST was significantly greater in abdomen (mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>SD, 24.7<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>14.3<span class="elsevierStyleHsp" style=""></span>mm) than in thigh (11.6<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>4.9<span class="elsevierStyleHsp" style=""></span>mm) or in arm (9.1<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>4.5<span class="elsevierStyleHsp" style=""></span>mm) (<span class="elsevierStyleItalic">P</span><.0005).</p><p id="par0040" class="elsevierStylePara elsevierViewall">The injection site was significantly associated with clinical disease activity measured by DAS28-CRP/ASDAS. The percentage of patients with active disease was significantly higher among those who self-administered the anti-TNF agents in arm (n=9; 75.0% of the patients) than in those who self-administered the treatment in abdomen (n=33; 40.2% of the patients) or thigh (n=4; 17.4% of the patients) (<span class="elsevierStyleItalic">P</span>=.004).</p><p id="par0045" class="elsevierStylePara elsevierViewall">The ST thickness may be an important factor in the selection of the needle length and injection technique,<a class="elsevierStyleCrossRefs" href="#bib0085"><span class="elsevierStyleSup">7–9</span></a> to ensure that the drug is administered to ST rather than IM tissue,<a class="elsevierStyleCrossRefs" href="#bib0090"><span class="elsevierStyleSup">8,10</span></a> which, in turn, influences the therapeutic response. High-frequency ultrasound enables direct measurements of ST thickness at any anatomical site and is harmless, easy to perform and rapid. Our results showed a significantly lower percentage of remission in the group that self-administered the anti-TNF agent in arm (n=12), with a significantly thinner ST layer (ST thickness in arm; mean<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>SD, 7.5<span class="elsevierStyleHsp" style=""></span>±<span class="elsevierStyleHsp" style=""></span>2.3<span class="elsevierStyleHsp" style=""></span>mm).</p><p id="par0050" class="elsevierStylePara elsevierViewall">We propose ultrasound measurement of ST thickness in patients who are to begin anti-TNF therapy or undergo a weight change once being treated, to ensure the correct selection of the injection site.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of Interest</span><p id="par0055" class="elsevierStylePara elsevierViewall">Lara Valor has received speaking fees from AbbVie, Roche Farma, Bristol-Myers Squibb and Pfizer.</p><p id="par0060" class="elsevierStylePara elsevierViewall">Inmaculada de la Torre is a European physician who has been working for Eli-Lilly & Co. since February 2013.</p><p id="par0065" class="elsevierStylePara elsevierViewall">Esperanza Naredo has received speaking fees from AbbVie, Roche Farma, Bristol-Myers Squibb, Pfizer, UCB Pharma, General Electric Healthcare and Esaote. She has also received research funding from <span class="elsevierStyleGrantSponsor" id="gs1">UCB Pharma</span> and <span class="elsevierStyleGrantSponsor" id="gs2">Merck Sharp & Dohme</span>.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of Interest" ] 1 => array:2 [ "identificador" => "xack276281" "titulo" => "Acknowledgments" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: del Río T, Valor L, de la Torre I, Naredo E. Impacto del grosor del tejido celular subcutáneo en el sitio de la inyección medido por ecografía sobre la respuesta terapéutica a fármacos antifactor de necrosis tumoral subcutáneos. Reumatol Clin. 2016;12:300–301.</p>" ] ] "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 1125 "Ancho" => 3250 "Tamanyo" => 375382 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Ultrasound images of subcutaneous tissue. (A) Right arm. (B) Right abdomen. (C) Right thigh.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:10 [ 0 => array:3 [ "identificador" => "bib0055" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Treatment with TNFalpha blockers induces phenotypical and functional aberrations in peripheral B cells" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "M.P. Karampetsou" 1 => "A.P. Andonopoulos" 2 => "S.N. 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We also thank Jesús Garrido for his help with the statistical study.</p>" "vista" => "all" ] ] ] "idiomaDefecto" => "en" "url" => "/21735743/0000001200000005/v3_201704020032/S2173574316300557/v3_201704020032/en/main.assets" "Apartado" => array:4 [ "identificador" => "8400" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letters to the Editor" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/21735743/0000001200000005/v3_201704020032/S2173574316300557/v3_201704020032/en/main.pdf?idApp=UINPBA00004M&text.app=https://reumatologiaclinica.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2173574316300557?idApp=UINPBA00004M" ]
| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 9 | 15 | 24 |
| 2024 October | 51 | 25 | 76 |
| 2024 September | 52 | 16 | 68 |
| 2024 August | 54 | 40 | 94 |
| 2024 July | 60 | 34 | 94 |
| 2024 June | 71 | 37 | 108 |
| 2024 May | 95 | 28 | 123 |
| 2024 April | 68 | 23 | 91 |
| 2024 March | 50 | 35 | 85 |
| 2024 February | 55 | 27 | 82 |
| 2024 January | 69 | 31 | 100 |
| 2023 December | 33 | 31 | 64 |
| 2023 November | 51 | 21 | 72 |
| 2023 October | 61 | 27 | 88 |
| 2023 September | 72 | 43 | 115 |
| 2023 August | 60 | 14 | 74 |
| 2023 July | 42 | 27 | 69 |
| 2023 June | 65 | 23 | 88 |
| 2023 May | 56 | 25 | 81 |
| 2023 April | 36 | 14 | 50 |
| 2023 March | 71 | 26 | 97 |
| 2023 February | 71 | 29 | 100 |
| 2023 January | 64 | 24 | 88 |
| 2022 December | 65 | 41 | 106 |
| 2022 November | 47 | 23 | 70 |
| 2022 October | 46 | 25 | 71 |
| 2022 September | 78 | 32 | 110 |
| 2022 August | 73 | 37 | 110 |
| 2022 July | 80 | 28 | 108 |
| 2022 June | 76 | 30 | 106 |
| 2022 May | 83 | 34 | 117 |
| 2022 April | 59 | 34 | 93 |
| 2022 March | 67 | 45 | 112 |
| 2022 February | 74 | 36 | 110 |
| 2022 January | 38 | 27 | 65 |
| 2021 December | 32 | 36 | 68 |
| 2021 November | 44 | 33 | 77 |
| 2021 October | 72 | 58 | 130 |
| 2021 September | 43 | 37 | 80 |
| 2021 August | 45 | 54 | 99 |
| 2021 July | 30 | 35 | 65 |
| 2021 June | 59 | 43 | 102 |
| 2021 May | 60 | 36 | 96 |
| 2021 April | 91 | 87 | 178 |
| 2021 March | 66 | 41 | 107 |
| 2021 February | 41 | 16 | 57 |
| 2021 January | 37 | 26 | 63 |
| 2020 December | 32 | 11 | 43 |
| 2020 November | 35 | 16 | 51 |
| 2020 October | 23 | 13 | 36 |
| 2020 September | 38 | 25 | 63 |
| 2020 August | 40 | 18 | 58 |
| 2020 July | 36 | 14 | 50 |
| 2020 June | 40 | 18 | 58 |
| 2020 May | 39 | 14 | 53 |
| 2020 April | 22 | 13 | 35 |
| 2020 March | 12 | 8 | 20 |
| 2018 December | 2 | 0 | 2 |
| 2018 May | 7 | 1 | 8 |
| 2018 April | 36 | 9 | 45 |
| 2018 March | 50 | 6 | 56 |
| 2018 February | 28 | 9 | 37 |
| 2018 January | 34 | 6 | 40 |
| 2017 December | 30 | 5 | 35 |
| 2017 November | 45 | 12 | 57 |
| 2017 October | 26 | 6 | 32 |
| 2017 September | 28 | 13 | 41 |
| 2017 August | 20 | 7 | 27 |
| 2017 July | 29 | 12 | 41 |
| 2017 June | 45 | 14 | 59 |
| 2017 May | 45 | 10 | 55 |
| 2017 April | 22 | 11 | 33 |
| 2017 March | 29 | 24 | 53 |
| 2017 February | 17 | 9 | 26 |
| 2017 January | 27 | 6 | 33 |
| 2016 December | 45 | 18 | 63 |
| 2016 November | 41 | 23 | 64 |
| 2016 October | 72 | 31 | 103 |
| 2016 September | 61 | 11 | 72 |
| 2016 August | 26 | 6 | 32 |
| 2016 July | 12 | 3 | 15 |
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