Jordi Gratacós-Masmitja , Emma Beltrán Catalán , José Luis Álvarez Vega , Ana Urruticoechea-Arana , Concepción Fito , Francisco Maceiras , Joaquín María Belzunegui Otano , Julia Fernández Melón , Eugenio Chamizo Carmona , Miguel Ángel Abad Hernández , Inmaculada Ros Vilamajó , Sonia Castro Oreiro , Eva Pascual Alfonso , Juan Carlos Torre Alonso , on behalf of the PREVAIL team
{"title":"阿普米司特在biologic-naïve银屑病关节炎患者中的实际应用。数据来自西班牙临床实践","authors":"Jordi Gratacós-Masmitja , Emma Beltrán Catalán , José Luis Álvarez Vega , Ana Urruticoechea-Arana , Concepción Fito , Francisco Maceiras , Joaquín María Belzunegui Otano , Julia Fernández Melón , Eugenio Chamizo Carmona , Miguel Ángel Abad Hernández , Inmaculada Ros Vilamajó , Sonia Castro Oreiro , Eva Pascual Alfonso , Juan Carlos Torre Alonso , on behalf of the PREVAIL team","doi":"10.1016/j.reuma.2023.06.007","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>Apremilast is approved for treatment of psoriasis and psoriatic arthritis (PsA). Real-world evidence on apremilast effectiveness in clinical practice is limited.</p></div><div><h3>Methods</h3><p>Observational study enrolling adult patients, across 21 Spanish centres, who had initiated apremilast in the prior 6 (±1) months and were biologic naive. Data were collected at routine follow-up visits 6 and 12 months after apremilast initiation. Primary outcome was 6 and 12-month persistence to apremilast. Secondary outcomes included Disease Activity for PsA (DAPSA), joint erosions, enthesitis, dactylitis, and patient-reported quality of life (QoL, measured using the PsA impact of disease [PsAID] questionnaire).</p></div><div><h3>Results</h3><p>We included 59 patients. Most had oligoarticular PsA, moderate disease activity, and high comorbidity burden. Three-quarters were continuing apremilast at 6 months and two-thirds at 12 months; mean (SD) apremilast treatment duration was 9.43 (1.75) months. DAPSA scores showed improved disease activity: one-third of patients in remission or low activity at apremilast initiation versus 62% and 78% at 6 and 12 months, respectively. Eleven of 46 patients with radiographic assessments had joint erosions at apremilast initiation and none at month 12. Median (<em>Q</em>1, <em>Q</em>3) number of swollen joints was 4.0 (2.0, 6.0) at apremilast initiation versus 0.0 (0.0, 2.0) at 12 months. Incidence of dactylitis and enthesitis decreased between apremilast initiation (35.6% and 28.8%, respectively) and month 12 (11.6% and 2.4%, respectively). Over two-thirds of patients had a PSAID-9 score <4 (cut-off for patient-acceptable symptom state) at month 12.</p></div><div><h3>Conclusions</h3><p>In Spanish clinical practice, two-thirds of PsA patients continued apremilast at 12 months, with clinical benefits at the joint level, no radiographic progression of erosions, and a positive impact on patient-reported QoL.</p><p>Trial registration number Clinicaltrials.gov: <span>NCT03828045</span><svg><path></path></svg>.</p></div>","PeriodicalId":47115,"journal":{"name":"Reumatologia Clinica","volume":null,"pages":null},"PeriodicalIF":1.2000,"publicationDate":"2023-08-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1699258X23001456/pdfft?md5=2b5793cb7ef3c0ece1f920fa0423c83f&pid=1-s2.0-S1699258X23001456-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Real-world apremilast use in biologic-naïve psoriatic arthritis patients. Data from Spanish clinical practice\",\"authors\":\"Jordi Gratacós-Masmitja , Emma Beltrán Catalán , José Luis Álvarez Vega , Ana Urruticoechea-Arana , Concepción Fito , Francisco Maceiras , Joaquín María Belzunegui Otano , Julia Fernández Melón , Eugenio Chamizo Carmona , Miguel Ángel Abad Hernández , Inmaculada Ros Vilamajó , Sonia Castro Oreiro , Eva Pascual Alfonso , Juan Carlos Torre Alonso , on behalf of the PREVAIL team\",\"doi\":\"10.1016/j.reuma.2023.06.007\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>Apremilast is approved for treatment of psoriasis and psoriatic arthritis (PsA). Real-world evidence on apremilast effectiveness in clinical practice is limited.</p></div><div><h3>Methods</h3><p>Observational study enrolling adult patients, across 21 Spanish centres, who had initiated apremilast in the prior 6 (±1) months and were biologic naive. Data were collected at routine follow-up visits 6 and 12 months after apremilast initiation. Primary outcome was 6 and 12-month persistence to apremilast. Secondary outcomes included Disease Activity for PsA (DAPSA), joint erosions, enthesitis, dactylitis, and patient-reported quality of life (QoL, measured using the PsA impact of disease [PsAID] questionnaire).</p></div><div><h3>Results</h3><p>We included 59 patients. Most had oligoarticular PsA, moderate disease activity, and high comorbidity burden. Three-quarters were continuing apremilast at 6 months and two-thirds at 12 months; mean (SD) apremilast treatment duration was 9.43 (1.75) months. DAPSA scores showed improved disease activity: one-third of patients in remission or low activity at apremilast initiation versus 62% and 78% at 6 and 12 months, respectively. Eleven of 46 patients with radiographic assessments had joint erosions at apremilast initiation and none at month 12. Median (<em>Q</em>1, <em>Q</em>3) number of swollen joints was 4.0 (2.0, 6.0) at apremilast initiation versus 0.0 (0.0, 2.0) at 12 months. Incidence of dactylitis and enthesitis decreased between apremilast initiation (35.6% and 28.8%, respectively) and month 12 (11.6% and 2.4%, respectively). Over two-thirds of patients had a PSAID-9 score <4 (cut-off for patient-acceptable symptom state) at month 12.</p></div><div><h3>Conclusions</h3><p>In Spanish clinical practice, two-thirds of PsA patients continued apremilast at 12 months, with clinical benefits at the joint level, no radiographic progression of erosions, and a positive impact on patient-reported QoL.</p><p>Trial registration number Clinicaltrials.gov: <span>NCT03828045</span><svg><path></path></svg>.</p></div>\",\"PeriodicalId\":47115,\"journal\":{\"name\":\"Reumatologia Clinica\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2023-08-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S1699258X23001456/pdfft?md5=2b5793cb7ef3c0ece1f920fa0423c83f&pid=1-s2.0-S1699258X23001456-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Reumatologia Clinica\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1699258X23001456\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"RHEUMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Reumatologia Clinica","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1699258X23001456","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"RHEUMATOLOGY","Score":null,"Total":0}
Real-world apremilast use in biologic-naïve psoriatic arthritis patients. Data from Spanish clinical practice
Introduction
Apremilast is approved for treatment of psoriasis and psoriatic arthritis (PsA). Real-world evidence on apremilast effectiveness in clinical practice is limited.
Methods
Observational study enrolling adult patients, across 21 Spanish centres, who had initiated apremilast in the prior 6 (±1) months and were biologic naive. Data were collected at routine follow-up visits 6 and 12 months after apremilast initiation. Primary outcome was 6 and 12-month persistence to apremilast. Secondary outcomes included Disease Activity for PsA (DAPSA), joint erosions, enthesitis, dactylitis, and patient-reported quality of life (QoL, measured using the PsA impact of disease [PsAID] questionnaire).
Results
We included 59 patients. Most had oligoarticular PsA, moderate disease activity, and high comorbidity burden. Three-quarters were continuing apremilast at 6 months and two-thirds at 12 months; mean (SD) apremilast treatment duration was 9.43 (1.75) months. DAPSA scores showed improved disease activity: one-third of patients in remission or low activity at apremilast initiation versus 62% and 78% at 6 and 12 months, respectively. Eleven of 46 patients with radiographic assessments had joint erosions at apremilast initiation and none at month 12. Median (Q1, Q3) number of swollen joints was 4.0 (2.0, 6.0) at apremilast initiation versus 0.0 (0.0, 2.0) at 12 months. Incidence of dactylitis and enthesitis decreased between apremilast initiation (35.6% and 28.8%, respectively) and month 12 (11.6% and 2.4%, respectively). Over two-thirds of patients had a PSAID-9 score <4 (cut-off for patient-acceptable symptom state) at month 12.
Conclusions
In Spanish clinical practice, two-thirds of PsA patients continued apremilast at 12 months, with clinical benefits at the joint level, no radiographic progression of erosions, and a positive impact on patient-reported QoL.
Trial registration number Clinicaltrials.gov: NCT03828045.
期刊介绍:
Una gran revista para cubrir eficazmente las necesidades de conocimientos en una patología de etiología, expresividad clínica y tratamiento tan amplios. Además es La Publicación Oficial de la Sociedad Española de Reumatología y del Colegio Mexicano de Reumatología y está incluida en los más prestigiosos índices de referencia en medicina.