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  1. Article: Subcutaneous infliximab CT-P13 without intravenous induction in psoriatic arthritis: A case report and pharmacokinetic considerations.

    Ditto, Maria Chiara / Parisi, Simone / Cotugno, Valentina / Barila, Diego Antonio / Lo Sardo, Luca / Cattel, Francesco / Fusaro, Enrico

    International journal of clinical pharmacology and therapeutics

    2024  Volume 62, Issue 3, Page(s) 122–125

    Abstract: Introduction: The biosimilar CT-P13, the first and only subcutaneous (SC) infliximab formulation, is recommended for patients with psoriatic arthritis (PsA) and can be administered as a maintenance treatment, to be started 4 weeks after the induction ... ...

    Abstract Introduction: The biosimilar CT-P13, the first and only subcutaneous (SC) infliximab formulation, is recommended for patients with psoriatic arthritis (PsA) and can be administered as a maintenance treatment, to be started 4 weeks after the induction treatment with 2 intravenous (IV) infliximab infusions.
    Objective: To evaluate treatment with SC infliximab without prior IV infusion induction to meet patient needs.
    Materials and methods: After approval by the ethics review board and based on the schedule approved for rheumatoid arthritis, SC induction was performed with infliximab CT-P13 120 mg weekly for 4 weeks, followed by an injection of 120 mg every 2 weeks.
    Results: After 4 months of therapy, joint symptoms were resolved, inflammation parameters were normalized (erythrocyte sedimentation rate) reduced from 42 to 16 mm/h, and C-reactive protein from 1.74 to 0.43 mg/dL), and clinical assessment parameters were improved. After 9 months of therapy, the clinical data remained stable, with no adverse events or local side effects.
    Conclusion: SC infliximab was successfully used without previous IV infusion induction. Although, to date, the induction of PsA treatment via the SC route is not foreseen, the known pharmacokinetic properties and the outcome improvements observed in our patient show that subcutaneous treatment induction, as is already done in the treatment of rheumatoid arthritis, is also possible.
    MeSH term(s) Humans ; Infliximab/adverse effects ; Arthritis, Psoriatic/drug therapy ; Treatment Outcome ; Arthritis, Rheumatoid/drug therapy ; Biosimilar Pharmaceuticals/adverse effects ; Antibodies, Monoclonal
    Chemical Substances Infliximab (B72HH48FLU) ; CT-P13 ; Biosimilar Pharmaceuticals ; Antibodies, Monoclonal
    Language English
    Publishing date 2024-01-11
    Publishing country Germany
    Document type Case Reports ; Journal Article
    ZDB-ID 124384-6
    ISSN 0946-1965 ; 0340-0026 ; 0300-9718 ; 0174-4879
    ISSN 0946-1965 ; 0340-0026 ; 0300-9718 ; 0174-4879
    DOI 10.5414/CP204388
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Management of Patients Affected by Giant Cell Arteritis during the COVID-19 Pandemic: Telemedicine Protocol TELEMACOV.

    Parisi, Simone / Ditto, Maria Chiara / Talotta, Rossella / Laganà, Angela / Peroni, Clara Lisa / Fusaro, Enrico

    Journal of personalized medicine

    2023  Volume 13, Issue 4

    Abstract: Giant cell arteritis (GCA) is the most common primary systemic vasculitis in western countries, prevalently affecting elderly people. Both early diagnosis and regular monitoring are necessary for the correct management of GCA. Following the outbreak of ... ...

    Abstract Giant cell arteritis (GCA) is the most common primary systemic vasculitis in western countries, prevalently affecting elderly people. Both early diagnosis and regular monitoring are necessary for the correct management of GCA. Following the outbreak of the COVID-19 pandemic, government decisions aiming at reducing the contagion led to reductions in health activities, limiting them to urgent cases. At the same time, remote monitoring activities have been implemented through telephone contacts or video calls carried out by specialists. In line with these deep changes affecting the worldwide healthcare system and in consideration of the high risk of GCA morbidity, we activated the TELEMACOV protocol (TELEmedicine and Management of the patient affected by GCA during the COVID-19 pandemic) in order to remotely monitor patients affected by GCA. The aim of this study was to evaluate the effectiveness of telemedicine in the follow-up of patients already diagnosed with GCA. This was a monocenter observational study. Patients with a previous diagnosis of GCA admitted to the Rheumatology Unit of the University Hospital "Città della Salute e della Scienza" in Turin were monitored every 6-7 weeks by means of video/phone calls from 9 March to 9 June 2020. All patients were asked questions concerning the onset of new symptoms or their recurrence, exams carried out, changes in current therapy, and satisfaction with video/phone calls. We performed 74 remote monitoring visits in 37 GCA patients. Patients were mostly women (77.8%) and had a mean age of 71.85 ± 9.25 years old. The mean disease duration was 5.3 ± 2.3 months. A total of 19 patients received oral glucocorticoids (GC) alone at the time of diagnosis with a daily dose of 0.8-1 mg/kg (52.7 ± 18.3 mg) of prednisone, while 18 patients were treated with a combination of oral steroids (at the time of diagnosis, the prednisone mean dose was 51.7 ± 18.8 mg) and subcutaneous injections of tocilizumab (TCZ). During the follow-up, patients additionally treated with TCZ reduced their GC dose more than patients treated with GC alone (
    Language English
    Publishing date 2023-03-31
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2662248-8
    ISSN 2075-4426
    ISSN 2075-4426
    DOI 10.3390/jpm13040620
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: New Onset of Giant Cell Arteritis following ChAdOx1-S (Vaxevria

    Lo Sardo, Luca / Parisi, Simone / Ditto, Maria Chiara / De Giovanni, Rosanna / Maletta, Francesca / Grimaldi, Serena / Brussino, Luisa / Fusaro, Enrico

    Vaccines

    2023  Volume 11, Issue 2

    Abstract: We report a 78-year-old man presenting with persistent headaches in vertex and temporo-parietal area; fatigue, worsening after walking; jaw claudication; scotomas; pharyngodynia; and dry cough after the second dose of the SARS-CoV-2 vaccine (ChAdOx1-S) ... ...

    Abstract We report a 78-year-old man presenting with persistent headaches in vertex and temporo-parietal area; fatigue, worsening after walking; jaw claudication; scotomas; pharyngodynia; and dry cough after the second dose of the SARS-CoV-2 vaccine (ChAdOx1-S) administration. Laboratory findings showed an elevated C-reactive protein level and FDG-CT PET showed evidence of active large vessel vasculitis with diffuse abnormal artery uptake. Under suspicion of vasculitis, a temporal arteries biopsy was performed; the histopathologic findings demonstrated the transmural inflammatory infiltrate with giant cells, compatible with giant cell arteritis. Although the overall incidence of vaccine-triggered autoimmunity is low, rheumatologists worldwide should be aware of autoimmune diseases as a new potential adverse event of vaccines.
    Language English
    Publishing date 2023-02-13
    Publishing country Switzerland
    Document type Case Reports
    ZDB-ID 2703319-3
    ISSN 2076-393X
    ISSN 2076-393X
    DOI 10.3390/vaccines11020434
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article: Efficacy and Safety of Upadacitinib in Rheumatoid Arthritis: Real-Life Experience from a Prospective Longitudinal Multicentric Study.

    Baldi, Caterina / Parisi, Simone / Falsetti, Paolo / Sota, Jurgen / Ditto, Maria Chiara / Capassoni, Marco / D'alessandro, Miriana / Conticini, Edoardo / Nacci, Francesca / Peroni, Clara Lisa / Cometi, Laura / Fusaro, Enrico / Frediani, Bruno / Guiducci, Serena

    Journal of clinical medicine

    2024  Volume 13, Issue 2

    Abstract: Background: We provide the first prospective longitudinal multicenter experience on Upadacitinib efficacy and safety profile in Rheumatoid Arthritis (RA) in a real-life context, focusing on clinimetric and ultrasonographic (US) data.: Methods: RA ... ...

    Abstract Background: We provide the first prospective longitudinal multicenter experience on Upadacitinib efficacy and safety profile in Rheumatoid Arthritis (RA) in a real-life context, focusing on clinimetric and ultrasonographic (US) data.
    Methods: RA patients referred to three Italian tertiary Centers who started Upadacitinib were enrolled as per ACR/EULAR classification criteria and prospectively reviewed. The primary aim of this study was to assess changes in clinimetric and ultrasonographic scores through time (at baseline, after 1 month, 3 months, and 6 months from the beginning of the therapy). Secondary aims were to: (i) estimate the impact of biologic lines of treatment and concomitant therapies on response to therapy; (ii) explore changes in laboratory parameters; and (iii) find potential predictive factors associated with response to therapy.
    Results: Seventy-one patients (49 Females and 22 Males) were included. Clinimetric scores, including the Disease Activity Score (DAS28-CRP) and Simplified Clinical Disease Activity Index (SDAI), and US findings (synovial hypertrophy and power Doppler) significantly improved (
    Conclusion: Our real-life experience confirms the efficacy of Upadacitinib in terms of clinical and ultrasonographic improvement, as well as displaying a good safety profile.
    Language English
    Publishing date 2024-01-11
    Publishing country Switzerland
    Document type Journal Article
    ZDB-ID 2662592-1
    ISSN 2077-0383
    ISSN 2077-0383
    DOI 10.3390/jcm13020401
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article: Autoantibodies and Rheumatologic Manifestations in Hepatitis C Virus Infection

    Priora, Marta / Borrelli, Richard / Parisi, Simone / Ditto, Maria Chiara / Realmuto, Cristina / Laganà, Angela / Centanaro Di Vittorio, Chiara / Degiovanni, Rosanna / Peroni, Clara Lisa / Fusaro, Enrico

    Biology. 2021 Oct. 20, v. 10, no. 11

    2021  

    Abstract: HCV is a virus that can cause chronic infection which can result in a systemic disease that may include many rheumatologic manifestations such as arthritis, myalgia, sicca syndrome, cryoglobulinemia vasculitis as well as other non-rheumatological ... ...

    Abstract HCV is a virus that can cause chronic infection which can result in a systemic disease that may include many rheumatologic manifestations such as arthritis, myalgia, sicca syndrome, cryoglobulinemia vasculitis as well as other non-rheumatological disorders (renal failure, onco-haematological malignancies). In this population, the high frequency of rheumatoid factor (45–70%), antinuclear (10–40%) and anticardiolipin (15–20%) antibodies is a B-cell mediated finding sustained by the infection. However, the possibility that a primitive rheumatic pathology may coexist with the HCV infection is not to be excluded thus complicating a differential diagnosis between primitive and HCV-related disorders.
    Keywords B-lymphocytes ; arthritis ; autoantibodies ; hepatitis C ; renal failure ; vasculitis ; viruses
    Language English
    Dates of publication 2021-1020
    Publishing place Multidisciplinary Digital Publishing Institute
    Document type Article
    ZDB-ID 2661517-4
    ISSN 2079-7737
    ISSN 2079-7737
    DOI 10.3390/biology10111071
    Database NAL-Catalogue (AGRICOLA)

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  6. Article ; Online: Effectiveness of SB4 Transition from Originator Etanercept in Rheumatoid Arthritis and Axial Spondyloarthritis: A Subgroup Analysis from the BENEFIT Study.

    Luciano, Nicoletta / Fusaro, Enrico / Ditto, Maria Chiara / Ianniello, Aurora / Bellis, Emanuela / Bruni, Cosimo / Viapiana, Ombretta / Gremese, Elisa / Migliore, Alberto / Romoli, Ester / Conforti, Ludovica / Govoni, Marcello / Matucci-Cerinic, Marco / Selmi, Carlo

    Rheumatology and immunology research

    2022  Volume 3, Issue 1, Page(s) 31–37

    Abstract: Objectives: The pan-European BENEFIT study of patients with stable rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who transitioned from reference etanercept to SB4 found no clinically meaningful changes in disease control after transition. ...

    Abstract Objectives: The pan-European BENEFIT study of patients with stable rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who transitioned from reference etanercept to SB4 found no clinically meaningful changes in disease control after transition. The analysis aims to illustrate the peculiarities of the Italian cohort of patients compared with the whole population to provide a more real-life approach to the data for the Italian rheumatologists, ruling out possible local confounding factors.
    Methods: A prospective study for up to 6 months following transition was conducted. Outcome measures of interest include clinical characteristics at time of transition and disease activity scores (Disease Activity Score-28 [DAS28] for RA, Bath Ankylosing Spondylitis Disease Activity Index [BASDAI] for axSpA) over time and safety.
    Results: One-hundred and eleven subjects (out of the 557 in total enrolled in the study) were derived from 8 Italian sites, including 79 with RA and 32 with axSpA. In both cohorts, the efficacy was maintained at 3 months and 6 months from the transition to the biosimilar with no significant change in mean DAS28 and BASDAI scores: at the end of the 6 months of observation the mean DAS28 and BASDAI was similar to baseline (confidence interval [CI] -0.22, 0.22), while the mean variation of the BASDAI was -0.14. Of note, 100.0% (95% CI 89.1, 100.0) in the axSpA and 90.8% (95% CI 81.5, 95.5) in the RA cohort of patients continued to receive SB4 at month 6 (binary variable with 95% Clopper-Pearson CI).
    Conclusions: Italian patients with stable RA or axSpA who transitioned from originator Etanercept to SB4 maintained clinical response at 6 months post-transition. Both the cohorts are representative of typical patients with long-standing established diagnoses. Most of the patients transitioned to the same dose regimen of biosimilar as that received for the originator, and the regimen remained unchanged at 6 months, supporting the effectiveness of the transition.
    Language English
    Publishing date 2022-04-20
    Publishing country Germany
    Document type Journal Article
    ISSN 2719-4523
    ISSN (online) 2719-4523
    DOI 10.2478/rir-2022-0005
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: Efficacy and safety of a single switch from etanercept originator to etanercept biosimilar in a cohort of inflammatory arthritis.

    Ditto, Maria Chiara / Parisi, Simone / Priora, Marta / Sanna, Silvia / Peroni, Clara Lisa / Laganà, Angela / D'Avolio, Antonio / Fusaro, Enrico

    Scientific reports

    2020  Volume 10, Issue 1, Page(s) 16178

    Abstract: AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly ...

    Abstract AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.
    MeSH term(s) Aged ; Aged, 80 and over ; Antirheumatic Agents/adverse effects ; Antirheumatic Agents/therapeutic use ; Arthritis, Psoriatic/drug therapy ; Arthritis, Rheumatoid/drug therapy ; Biosimilar Pharmaceuticals/adverse effects ; Biosimilar Pharmaceuticals/therapeutic use ; Drug Substitution ; Etanercept/therapeutic use ; Female ; Humans ; Italy ; Male ; Middle Aged ; Spondylitis, Ankylosing/drug therapy ; Treatment Outcome
    Chemical Substances Antirheumatic Agents ; Biosimilar Pharmaceuticals ; Etanercept (OP401G7OJC)
    Language English
    Publishing date 2020-09-30
    Publishing country England
    Document type Journal Article
    ZDB-ID 2615211-3
    ISSN 2045-2322 ; 2045-2322
    ISSN (online) 2045-2322
    ISSN 2045-2322
    DOI 10.1038/s41598-020-73183-0
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  8. Article ; Online: Rheumatic manifestations in inflammatory bowel disease.

    Finucci, Annacarla / Ditto, Maria Chiara / Parisi, Simone / Borrelli, Richard / Priora, Marta / Realmuto, Cristina / Fusaro, Enrico

    Minerva gastroenterology

    2020  Volume 67, Issue 1, Page(s) 79–90

    Abstract: Rheumatic manifestations are the most frequent extra-intestinal manifestations (EIMs) in inflammatory bowel disease (IBD) patients, and they are responsible for a relevant reduction of quality of life. IBD is associated with a variety of musculoskeletal ... ...

    Abstract Rheumatic manifestations are the most frequent extra-intestinal manifestations (EIMs) in inflammatory bowel disease (IBD) patients, and they are responsible for a relevant reduction of quality of life. IBD is associated with a variety of musculoskeletal manifestations such as arthritis and non-inflammatory pain as well as with metabolic diseases, such as osteoporosis. Different imaging techniques (primarily ultrasound, magnetic resonance imaging and X-rays) can help the clinician to correctly identify the nature of manifestations and to treat the patient accordingly. Nowadays, in the setting of IBD-related arthritides, different drugs are available and can be effective on both articular and intestinal involvement. Therefore, a multi-disciplinary approach provides an early diagnosis and a better clinical outcome that can only be given from the recognition and consideration of the different EIMs. As for rheumatic manifestations, namely IBD-related arthritis, an early intervention allows to control disease activity and to prevent structural damage.
    MeSH term(s) Humans ; Inflammatory Bowel Diseases/complications ; Inflammatory Bowel Diseases/diagnosis ; Rheumatic Diseases/etiology
    Language English
    Publishing date 2020-07-03
    Publishing country Italy
    Document type Journal Article ; Review
    ZDB-ID 3062713-8
    ISSN 2724-5365
    ISSN (online) 2724-5365
    DOI 10.23736/S2724-5985.20.02726-9
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  9. Article ; Online: Accelerated subcutaneous nodulosis in patients with rheumatoid arthritis treated with tocilizumab: a case series.

    Talotta, Rossella / Atzeni, Fabiola / Batticciotto, Alberto / Ditto, Maria Chiara / Gerardi, Maria Chiara / Sarzi-Puttini, Piercarlo

    Journal of medical case reports

    2018  Volume 12, Issue 1, Page(s) 154

    Abstract: Background: Tocilizumab is a monoclonal antibody directed against the interleukin-6 receptor, which is approved for the treatment of moderate-to-severe rheumatoid arthritis. Authors have found that it prevents lung and subcutaneous nodulosis in patients ...

    Abstract Background: Tocilizumab is a monoclonal antibody directed against the interleukin-6 receptor, which is approved for the treatment of moderate-to-severe rheumatoid arthritis. Authors have found that it prevents lung and subcutaneous nodulosis in patients with rheumatoid arthritis but, to the best of our knowledge, there are no data concerning the acceleration of subcutaneous nodulosis during tocilizumab therapy.
    Case presentation: We report for the first time a small case series of five patients with rheumatoid arthritis: a 46-year-old white woman, a 70-year-old white woman, a 63-year-old white woman, a 69-year-old white man, and a 72-year-old white woman (mean age 64 ± 10.6 years); they experienced worsening subcutaneous nodulosis during treatment with intravenously administered tocilizumab. Four of the five patients were positive for rheumatoid factor and five for anti-citrullinated peptide antibodies. All of the patients had previously been treated with various conventional and biological drugs; at the time of our observation, three were taking methotrexate, two hydroxychloroquine, and four were taking prednisone. Tocilizumab 8 mg/kg was administered intravenously every 4 weeks for a mean of 43.4 ± 32.4 months, and led to good disease control in three cases. All of the patients had a history of subcutaneous nodulosis, which considerably worsened during tocilizumab treatment, with the development of new nodules on their fingers, elbows, or in the inframammary fold, tending to ulcerate. The management of this medical event included discontinuation of methotrexate, the administration of steroids, the addition of hydroxychloroquine or colchicine, the use of antibiotics, and surgery. However, neither pharmacological nor surgical treatment was completely effective, as the nodules tended to recur and increased in number and size.
    Conclusions: To the best of our knowledge, this is the first report describing accelerated subcutaneous nodulosis in a small case series of patients with rheumatoid arthritis treated with tocilizumab.
    MeSH term(s) Aged ; Antibodies, Monoclonal, Humanized/therapeutic use ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/drug therapy ; Female ; Humans ; Male ; Methotrexate/therapeutic use ; Middle Aged ; Rheumatoid Nodule/drug therapy
    Chemical Substances Antibodies, Monoclonal, Humanized ; Antirheumatic Agents ; tocilizumab (I031V2H011) ; Methotrexate (YL5FZ2Y5U1)
    Language English
    Publishing date 2018-06-03
    Publishing country England
    Document type Case Reports ; Journal Article
    ZDB-ID 2269805-X
    ISSN 1752-1947 ; 1752-1947
    ISSN (online) 1752-1947
    ISSN 1752-1947
    DOI 10.1186/s13256-018-1687-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  10. Article ; Online: Risk factors of suspected spondyloarthritis among inflammatory bowel disease patients.

    Ribaldone, Davide Giuseppe / Vernero, Marta / Parisi, Simone / Ditto, Maria Chiara / Pellicano, Rinaldo / Morino, Mario / Saracco, Giorgio Maria / Fusaro, Enrico / Astegiano, Marco

    Scandinavian journal of gastroenterology

    2019  Volume 54, Issue 10, Page(s) 1233–1236

    Abstract: Background: ...

    Abstract Background:
    MeSH term(s) Adult ; Aged ; Female ; Humans ; Inflammatory Bowel Diseases/complications ; Male ; Middle Aged ; Prospective Studies ; Risk Factors ; Sensitivity and Specificity ; Spondylarthritis/diagnosis ; Spondylarthritis/etiology ; Surveys and Questionnaires
    Language English
    Publishing date 2019-09-24
    Publishing country England
    Document type Clinical Trial ; Journal Article
    ZDB-ID 82042-8
    ISSN 1502-7708 ; 0036-5521
    ISSN (online) 1502-7708
    ISSN 0036-5521
    DOI 10.1080/00365521.2019.1668052
    Database MEDical Literature Analysis and Retrieval System OnLINE

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