Biologics : Targets & Therapy最新文献

{"title":"Systematic review of immunomodulatory therapies for hidradenitis suppurativa.","authors":"Shi Yu Derek Lim,&nbsp;Hazel H Oon","doi":"10.2147/BTT.S199862","DOIUrl":"https://doi.org/10.2147/BTT.S199862","url":null,"abstract":"<p><p><b>Background:</b> Greater understanding of the roles of tumor necrosis factor-α, IL-1β, IL-10, and the IL-23/T-helper (Th) 17 and IL-12/Th1 pathways in immune dysregulation in moderate/severe hidradenitis suppurativa (HS) has helped in developing new regimens. We aim to review the use of different immunomodulatory therapies used to manage HS. <b>Methods:</b> A comprehensive literature search was conducted on the PubMed and Clinicaltrials.gov databases from 1 January 1947 to 31 December 2018. Only clinical trials, case reports, case series and retrospective analyses published in the English language were included. <b>Results:</b> Our search yielded 107 articles and 35 clinical trials, of which 15 are still ongoing. The tumor necrosis factor-α inhibitors adalimumab and infliximab were the most comprehensively studied agents. Published data from clinical trials support the efficacy of adalimumab, infliximab, anakinra, ustekinumab, bermekimab and apremilast but not etanercept and MEDI8968. Clinical trials for CJM112 have been completed, with results awaiting publication. Trials are underway for secukinumab, IFX-1, INCB054707 and bimekizumab. Biologics used in smaller cohorts include canakinumab, golimumab and rituximab. Most agents are well tolerated and demonstrate a good safety profile, with the most commonly reported adverse event being infections. <b>Discussion and conclusions:</b> To date, adalimumab is the only biologic which has been approved by the United States Food and Drug Administration for HS. However, other agents also show promise, with further trials underway to evaluate their efficacy, tolerability and safety profiles. Different clinical measurement scores and endpoints used to make direct comparison difficult. Longitudinal surveillance and pooled registry data are paramount to evaluate the long-term safety profile and efficacy of therapy.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"13 ","pages":"53-78"},"PeriodicalIF":4.0,"publicationDate":"2019-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S199862","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37324017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Monoclonal antibody therapy of solid tumors: clinical limitations and novel strategies to enhance treatment efficacy.","authors":"Esteban Cruz,&nbsp;Veysel Kayser","doi":"10.2147/BTT.S166310","DOIUrl":"10.2147/BTT.S166310","url":null,"abstract":"Abstract Monoclonal antibodies (mAbs) have become a cornerstone in the therapeutic guidelines of a wide range of solid tumors. The targeted nature of these biotherapeutics has improved treatment outcomes by offering enhanced specificity to reduce severe side effects experienced with conventional chemotherapy. Notwithstanding, poor tumor tissue penetration and the heterogeneous distribution achieved therein are prominent drawbacks that hamper the clinical efficacy of therapeutic antibodies. Failure to deliver efficacious doses throughout the tumor can lead to treatment failure and the development of acquired resistance mechanisms. Comprehending the morphological and physiological characteristics of solid tumors and their microenvironment that affect tumor penetration and distribution is a key requirement to improve clinical outcomes and realize the full potential of monoclonal antibodies in oncology. This review summarizes the essential architectural characteristics of solid tumors that obstruct macromolecule penetration into the targeted tissue following systemic delivery. It further describes mechanisms of resistance elucidated for blockbuster antibodies for which extensive clinical data exists, as a way to illustrate various modes in which cancer cells can overcome the anticancer activity of therapeutic antibodies. Thereafter, it describes novel strategies designed to improve clinical outcomes of mAbs by increasing potency and/or improving tumor delivery; focusing on the recent clinical success and growing clinical pipeline of antibody-drug conjugates, immune checkpoint inhibitors and nanoparticle-based delivery systems.","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"13 ","pages":"33-51"},"PeriodicalIF":4.0,"publicationDate":"2019-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S166310","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37263776","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Has infliximab influenced the course and prognosis of acute severe ulcerative colitis?","authors":"Angelo Viscido, Claudio Papi, Giovanni Latella, Giuseppe Frieri","doi":"10.2147/BTT.S179006","DOIUrl":"10.2147/BTT.S179006","url":null,"abstract":"<p><p>Ulcerative colitis (UC) still has no definitive cure since its etiology remains unclear. In recent years, considerable progress has been made with regard to our knowledge of the pathogenesis of UC. Advances in biotechnology have led to the development of biologic therapies which selectively target single key mediators or receptors involved in the pathogenesis of the disease - ie, tumor necrosis factor (TNF)-α, integrin, interleukins 12/23. Biologic therapies caused a revolution in the treatment of UC, providing specific options for patients refractory to conventional treatment. In recent years, antibodies anti-TNFα and anti-integrin have shown efficacy in improving the course and prognosis of ambulatory patients with moderate-to-severe UC. Nevertheless, whether biologics have brought so many benefits also for hospitalized patients with acute severe UC is still debated. Acute severe UC is a potentially life-threatening condition that affects up to 25% of patients during the course of their disease. It requires hospital admission due to the risk of complications and death, and it can necessitate urgent colectomy. Major adverse outcomes of acute severe UC are mortality and colectomy. The aim of this systematic review of the literature was to analyze the impact of biologics, in particular infliximab, on the course and prognosis of acute severe UC. Mortality and colectomy rates were considered as outcome measures.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"13 ","pages":"23-31"},"PeriodicalIF":5.3,"publicationDate":"2019-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/3f/83/btt-13-23.PMC6497489.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37265437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy of adalimumab as second-line therapy in a pediatric cohort of Crohn's disease patients who failed infliximab therapy: the Italian Society of Pediatric Gastroenterology, Hepatology, and Nutrition experience.","authors":"Patrizia Alvisi,&nbsp;Serena Arrigo,&nbsp;Salvatore Cucchiara,&nbsp;Paolo Lionetti,&nbsp;Erasmo Miele,&nbsp;Claudio Romano,&nbsp;Alberto Ravelli,&nbsp;Daniela Knafelz,&nbsp;Stefano Martelossi,&nbsp;Graziella Guariso,&nbsp;Salvatore Accomando,&nbsp;Giovanna Zuin,&nbsp;Costantino De Giacomo,&nbsp;Lucio Balzani,&nbsp;Monia Gennari,&nbsp;Marina Aloi","doi":"10.2147/BTT.S183088","DOIUrl":"https://doi.org/10.2147/BTT.S183088","url":null,"abstract":"<p><strong>Background: </strong>Adalimumab (Ada) treatment is an available option for pediatric Crohn's disease (CD) and the published experience as rescue therapy is limited.</p><p><strong>Objectives: </strong>We investigated Ada efficacy in a retrospective, pediatric CD cohort who had failed previous infliximab treatment, with a minimum follow-up of 6 months.</p><p><strong>Methods: </strong>In this multicenter study, data on demographics, clinical activity, growth, laboratory values (CRP) and adverse events were collected from CD patients during follow-up. Clinical remission (CR) and response were defined with Pediatric CD Activity Index (PCDAI) score ≤10 and a decrease in PCDAI score of ≥12.5 from baseline, respectively.</p><p><strong>Results: </strong>A total of 44 patients were consecutively recruited (mean age 14.8 years): 34 of 44 (77%) had active disease (mean PCDAI score 24.5) at the time of Ada administration, with a mean disease duration of 3.4 (range 0.3-11.2) years. At 6, 12, and 18 months, out of the total of the enrolled population, CR rates were 55%, 78%, and 52%, respectively, with a significant decrease in PCDAI scores (<i>P</i><0.01) and mean CRP values (mean CRP 5.7 and 2.4 mL/dL, respectively; <i>P</i><0.01) at the end of follow-up. Steroid-free remission rates, considered as the total number of patients in CR who were not using steroids at the end of this study, were 93%, 95%, and 96% in 44 patients at 6, 12, and 18 months, respectively. No significant differences in growth parameters were detected. In univariate analysis of variables related to Ada efficacy, we found that only a disease duration >2 years was negatively correlated with final PCDAI score (<i>P</i><0.01). Two serious adverse events were recorded: 1 meningitis and 1 medulloblastoma.</p><p><strong>Conclusion: </strong>Our data confirm Ada efficacy in pediatric patients as second-line biological therapy after infliximab failure. Longer-term prospective data are warranted to define general effectiveness and safety in pediatric CD patients.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"13 ","pages":"13-21"},"PeriodicalIF":4.0,"publicationDate":"2019-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S183088","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36864542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Spotlight on dinutuximab in the treatment of high-risk neuroblastoma: development and place in therapy.","authors":"Michelle E Keyel,&nbsp;C Patrick Reynolds","doi":"10.2147/BTT.S114530","DOIUrl":"10.2147/BTT.S114530","url":null,"abstract":"<p><p>Neuroblastoma (NB) is a pediatric cancer of the sympathetic nervous system which accounts for 8% of childhood cancers. Most NBs express high levels of the disialoganglioside GD2. Several antibodies have been developed to target GD2 on NB, including the human/mouse chimeric antibody ch14.18, known as dinutuximab. Dinutuximab used in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and isotretinoin (13-<i>cis-</i>retinoic acid) has a US Food and Drug Administration (FDA)-registered indication for treating high-risk NB patients who achieved at least a partial response to prior first-line multi-agent, multimodality therapy. The FDA registration resulted from a prospective randomized trial assessing the benefit of adding dinutuximab + cytokines to post-myeloablative maintenance therapy for high-risk NB. Dinutuximab has also shown promising antitumor activity when combined with temozolomide and irinotecan in treating NB progressive disease. Clinical activity of dinutuximab and other GD2-targeted therapies relies on the presence of the GD2 antigen on NB cells. Some NBs have been reported as GD2 low or negative, and such tumor cells could be nonresponsive to anti-GD2 therapy. As dinutuximab relies on complement and effector cells to mediate NB killing, factors affecting those components of patient response may also decrease dinutuximab effectiveness. This review summarizes the development of GD2 antibody-targeted therapy, the use of dinutuximab in both up-front and salvage therapy for high-risk NB, and the potential mechanisms of resistance to dinutuximab.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"13 ","pages":"1-12"},"PeriodicalIF":4.0,"publicationDate":"2018-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S114530","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36881307","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The role of microfluidics in protein formulations with pre-programmed functional characteristics.","authors":"Hu Meng,&nbsp;Shuai Deng,&nbsp;Yajing You,&nbsp;Hon Fai Chan","doi":"10.2147/BTT.S126725","DOIUrl":"https://doi.org/10.2147/BTT.S126725","url":null,"abstract":"<p><p>Protein-based therapies hold great promise for treating many diseases. Nevertheless, the challenges of producing therapies with targeted attributes via standardized processes may hinder the development of protein formulations and clinical translation of the advanced therapies. Microfluidics represents a promising technology to develop protein formulations with pre-programmed functional characteristics, including size, morphology, and controlled drug release property. In this review, we discuss some examples of adopting microfluidics for fabricating particle- and fiber/tube-based formulations and highlight the advantages of microfluidics-assisted fabrication.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"12 ","pages":"191-197"},"PeriodicalIF":4.0,"publicationDate":"2018-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S126725","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36802282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Combination of EGFR-TKIs with chemotherapy versus chemotherapy or EGFR-TKIs alone in advanced NSCLC patients with EGFR mutation.","authors":"Miaomiao Wen,&nbsp;Jinghua Xia,&nbsp;Ying Sun,&nbsp;Xuejiao Wang,&nbsp;Xianghui Fu,&nbsp;Yanning Zhang,&nbsp;Zhipei Zhang,&nbsp;Yongan Zhou,&nbsp;Xiaofei Li","doi":"10.2147/BTT.S169305","DOIUrl":"https://doi.org/10.2147/BTT.S169305","url":null,"abstract":"<p><strong>Purpose: </strong>Both epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) and chemotherapy are widely applied for the treatment of advanced non-small-cell lung cancer (NSCLC) with EGFR mutations, and the combination of EGFR-TKIs and chemotherapy has been used for advanced NSCLC patients; however, little is known about the efficacy of the direct comparison among them.</p><p><strong>Patients and methods: </strong>The demographic and clinical characteristics of 92 patients harboring advanced NSCLC with EGFR mutation were retrospectively reviewed. We evaluated the effects of EGFR-TKIs, chemotherapy, and EGFR-TKIs plus chemotherapy on advanced NSCLC patients with EGFR mutations, and the efficacy of combination of chemotherapy and EGFR-TKIs vs chemotherapy or EGFR-TKIs alone in advanced NSCLC patients was evaluated.</p><p><strong>Results: </strong>The statistical results showed that the intercalated combination of EGFR-TKIs plus chemotherapy significantly improved progression-free survival (PFS; HR, 1.76; 95% CI 1.03-3.01; <i>P</i>=0.036; median, 20.5 vs 16 months) compared with EGFR-TKI monotherapy, but no difference in overall survival (OS) was observed between these two groups (HR, 1.52; 95% CI 0.81-2.83; <i>P</i>=0.19; median, 36 vs 29 months). However, patients who received the combination of chemotherapy and EGFR-TKIs had longer PFS (HR, 2.78; 95% CI 1.57-4.93; <i>P</i><0.0001; median, 20.5 vs 12 months) as well as OS (HR, 2.86; 95% CI 1.56-5.27; <i>P</i>=0.001; median, 36 vs 18 months) than those who received chemotherapy alone. Toxicities were mild among the three treatment groups. Rash and diarrhea were common adverse events (AEs) in the EGFR-TKI group, anemia and nausea in the chemotherapy group, and anemia and diarrhea in the combination group.</p><p><strong>Conclusion: </strong>This study demonstrated that the combination of chemotherapy with EGFR-TKIs as first-line treatment has a significant effect on PFS in patients with advanced NSCLC whose tumors harbor activating EGFR mutations. The combination treatment had more toxicity, but was clinically manageable.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"12 ","pages":"183-190"},"PeriodicalIF":4.0,"publicationDate":"2018-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S169305","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36831369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Infliximab dose adjustment can improve the clinical and radiographic outcomes of rheumatoid arthritis patients: REVIVE study results.","authors":"Yuji Nozaki,&nbsp;Yasuaki Nagare,&nbsp;Chisato Ashida,&nbsp;Daisuke Tomita,&nbsp;Akinori Okada,&nbsp;Asuka Inoue,&nbsp;Koji Kinoshita,&nbsp;Masanori Funauchi,&nbsp;Itaru Matsumura","doi":"10.2147/BTT.S187998","DOIUrl":"https://doi.org/10.2147/BTT.S187998","url":null,"abstract":"<p><strong>Purpose: </strong>We evaluated the clinical responses and radiographic outcomes of 90 patients with rheumatoid arthritis (RA) undergoing continuous or dose-adjusted infliximab treatment over 104 weeks.</p><p><strong>Patients and methods: </strong>Patients received 3 mg/kg infliximab continuously (the contin group; n=50), or the dose escalation and de-escalation of infliximab (3, 6, and 10 mg/kg) from week 14 (the adjusted group; n=40) based on the patient's Disease Activity Score in 28 joints (DAS28). The retention rate, clinical response, and radiographic assessment were determined at week 104.</p><p><strong>Results: </strong>The contin and adjusted groups' retention rates at week 104 were 56.8 and 66.7%, and the groups' low disease activity in the DAS28 was 39.1 and 66.7%, respectively. Remission based on the DAS28 and the American College of Rheumatology (ACR)/European League against Rheumatism (EULAR) Boolean-based criteria was significantly increased in the adjusted group. In the radiographic assessment, there was also a significant reduction in the mean changes in total Sharp score. The cumulative rates of any adverse effects showed no significant difference between the groups.</p><p><strong>Conclusion: </strong>In an assessment of adequate DAS28 results, the RA patients who did not respond to the initial dose of infliximab showed improved clinical responses and radiographic assessment after a dose adjustment of infliximab, without an increased risk of serious adverse events.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"12 ","pages":"171-182"},"PeriodicalIF":4.0,"publicationDate":"2018-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S187998","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36788594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Structural and functional comparability study of anti-CD20 monoclonal antibody with reference product.","authors":"Sanjay Kumar Singh,&nbsp;Santosh Pokalwar,&nbsp;Sandip Bose,&nbsp;Shivika Gupta,&nbsp;Suhani Almal,&nbsp;Ranjit Sudhakar Ranbhor","doi":"10.2147/BTT.S187744","DOIUrl":"https://doi.org/10.2147/BTT.S187744","url":null,"abstract":"<p><strong>Background: </strong>Cell surface protein, CD20, is extensively expressed on the surface of B cells. Antibodies targeting CD20 protein are being used to treat B-cell malignancies and B-cell mediated autoimmune diseases. Considering the cost of therapy with innovator monoclonal antibodies for these diseases, development of biosimilar products for the treatment of such diseases provides affordable solution to rising healthcare costs.</p><p><strong>Materials and methods: </strong>Reference products of rituximab (six batches) were procured and stored as per manufacturer's instructions. Cell lines used in bioassay were procured from American Type Culture Collection and all other reagents used for analysis were of analytical grade. Primary structure was studied by intact mass analysis, peptide fingerprinting, peptide mass fingerprinting and sequence coverage analysis. Higher order structure was studied by circular dichroism, ultraviolet-visible spectroscopy, fluorescence spectroscopy, and disulfide bridge analysis. Different isoforms of reference product and SB-02 were identified using capillary isoelectric focusing and capillary zone electrophoresis. Glycosylation was studied by N-glycan mapping using LC-ESI-MS, point of glycosylation, released glycan analysis using ultra performance liquid chromatography (UPLC). Product related impurities such as oligomer content analysis and oxidized impurities were studied using size exclusion chromatography and reverse phase high performance liquid chromatography, respectively.</p><p><strong>Results and conclusion: </strong>Here, we report physicochemical and biological characterizations of Sun Pharma's proposed biosimilar (SB-02) to rituximab, a monoclonal anti-CD20 antibody approved for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia. SB-02 and rituximab exhibited indistinguishable primary as well as higher-order structure upon analyzing with the array of analytical and extended characterization methods according to statistical methods. The molecule also displayed comparability to reference product in post-translational modifications and charge heterogeneity. In functional bioassays, SB-02 demonstrated comparable potency with respect to reference product. Our results indicate highly similar quality profile between SB-02 and rituximab.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"12 ","pages":"159-170"},"PeriodicalIF":4.0,"publicationDate":"2018-11-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S187744","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36772576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Analysis of drug utilization and health care resource consumption in patients with psoriasis and psoriatic arthritis before and after treatment with biological therapies.","authors":"Luca Degli Esposti,&nbsp;Valentina Perrone,&nbsp;Diego Sangiorgi,&nbsp;Stefano Buda,&nbsp;Margherita Andretta,&nbsp;Maurizio Rossini,&nbsp;Giampiero Girolomoni","doi":"10.2147/BTT.S168691","DOIUrl":"https://doi.org/10.2147/BTT.S168691","url":null,"abstract":"<p><strong>Objectives: </strong>To describe the therapeutic pathways of patients with psoriasis (PSO) and psoriatic arthritis (PsA) before and after treatment with biological therapies in a real-world setting and to determine the relative consumption of health care resources.</p><p><strong>Design: </strong>Retrospective observational study.</p><p><strong>Setting: </strong>Real-life clinical setting in 5 Italian local health units.</p><p><strong>Participants: </strong>A total of 351 male and female patients with at least 1 prescription for a biological drug from January 1, 2010 to December 31, 2013; patients with concomitant rheumatoid arthritis, ankylosing spondylitis, or Crohn's disease were excluded.</p><p><strong>Results: </strong>The major health care cost (excluding drug costs) was represented by hospitalizations, mainly related to PSO /PsA-associated disorders and cardiometabolic disorders. Use of conventional drugs among biologics-naïve patients reached 50% in PSO and 80% in PsA; their use decreased following initiation of biological therapy. After the start of biological treatment, the incidence of hospitalization decreased both for PSO (from 12.3% to 3.2% in day hospital regimen and from 2.4% to 0.4% for conventional admission) and for PsA (from 11.1% to 8.1% and from 10.1% to 3.0%, respectively). Mean annual costs for hospitalization before biological treatment were €217 and €537 for PSO and PsA, respectively, while mean annual cost for concomitant drugs slightly increased after biologics initiation: from €249.8 to €269.4 for PSO and from €331.8 to €346.9 for PsA. The major consumption of health care resources occurred in the quarter preceding the beginning of biological treatment.</p><p><strong>Conclusion: </strong>The consumption of health resources is mostly related to hospitalization, seems to peak during the quarter before the beginning of biologics therapies, and subsequently decreases after biologics initiation. Further studies should focus on prescription scheme and economic burden of PSO and PsA in Italy to help optimize health care resources and potentiate services for patients.</p>","PeriodicalId":9025,"journal":{"name":"Biologics : Targets & Therapy","volume":"12 ","pages":"151-158"},"PeriodicalIF":4.0,"publicationDate":"2018-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2147/BTT.S168691","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"36799040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}