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Article ; Online: Abatacept and non-melanoma skin cancer in patients with rheumatoid arthritis: a comprehensive evaluation of randomised controlled trials and observational studies.

Simon, Teresa A / Dong, Lixian / Suissa, Samy / Michaud, Kaleb / Pedro, Sofia / Hochberg, Marc / Boers, Maarten / Askling, Johan / Frisell, Thomas / Strangfeld, Anja / Meissner, Yvette / Khaychuk, Vadim / Dominique, Alyssa / Maldonado, Michael A

Annals of the rheumatic diseases

2024 Volume 83, Issue 2, Page(s) 177–183

Abstract: Objectives: This study aims to evaluate non-melanoma skin cancer (NMSC) risk associated with abatacept treatment for rheumatoid arthritis (RA).: Methods: This evaluation included 16 abatacept RA clinical trials and 6 observational studies. NMSC ... ...

Abstract	Objectives: This study aims to evaluate non-melanoma skin cancer (NMSC) risk associated with abatacept treatment for rheumatoid arthritis (RA). Methods: This evaluation included 16 abatacept RA clinical trials and 6 observational studies. NMSC incidence rates (IRs)/1000 patient-years (p-y) of exposure were compared between patients treated with abatacept versus placebo, conventional synthetic (cs) disease-modifying antirheumatic drugs (DMARDs) and other biological/targeted synthetic (b/ts)DMARDs. For observational studies, a random-effects model was used to pool rate ratios (RRs). Results: ~49 000 patients receiving abatacept were analysed from clinical trials (~7000) and observational studies (~42 000). In randomised trials (n=4138; median abatacept exposure, 12 (range 2-30) months), NMSC IRs (95% CIs) were not significantly different for abatacept (6.0 (3.3 to 10.0)) and placebo (4.0 (1.3 to 9.3)) and remained stable throughout the long-term, open-label period (median cumulative exposure, 28 (range 2-130 months); 21 335 p-y of exposure (7044 patients over 3 years)). For registry databases, NMSC IRs/1000 p-y were 5-12 (abatacept), 1.6-10 (csDMARDs) and 3-8 (other b/tsDMARDs). Claims database IRs were 19-22 (abatacept), 15-18 (csDMARDs) and 14-17 (other b/tsDMARDs). Pooled RRs (95% CIs) from observational studies for NMSC in patients receiving abatacept were 1.84 (1.00 to 3.37) vs csDMARDs and 1.11 (0.98 to 1.26) vs other b/tsDMARDs. Conclusions: Consistent with the warnings and precautions of the abatacept label, this analysis suggests a potential increase in NMSC risk with abatacept use compared with csDMARDs. No significant increase was observed compared with b/tsDMARDs, but the lower limit of the 95% CI was close to unity.
MeSH term(s)	Humans ; Abatacept/adverse effects ; Antirheumatic Agents/adverse effects ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/epidemiology ; Arthritis, Rheumatoid/complications ; Biological Products/therapeutic use ; Incidence ; Randomized Controlled Trials as Topic ; Skin Neoplasms/chemically induced ; Skin Neoplasms/epidemiology
Chemical Substances	Abatacept (7D0YB67S97) ; Antirheumatic Agents ; Biological Products
Language	English
Publishing date	2024-01-11
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Review
ZDB-ID	7090-7
ISSN	1468-2060 ; 0003-4967
ISSN (online)	1468-2060
ISSN	0003-4967
DOI	10.1136/ard-2023-224356
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Article ; Online: ACPA-negative and ACPA-positive RA patients achieving disease resolution demonstrate distinct patterns of MRI-detected joint-inflammation.

Verstappen, Marloes / Matthijssen, Xanthe M E / Connolly, Sean E / Maldonado, Michael A / Huizinga, Tom W J / van der Helm-van Mil, Annette H M

Rheumatology (Oxford, England)

2022 Volume 62, Issue 1, Page(s) 124–134

Abstract: Objectives: Although sustained DMARD-free remission (SDFR; sustained absence of clinical-synovitis after DMARD-discontinuation) is increasingly achievable in RA, prevalence differs between ACPA-negative (40%) and ACPA-positive RA (5-10%). Additionally, ... ...

Abstract	Objectives: Although sustained DMARD-free remission (SDFR; sustained absence of clinical-synovitis after DMARD-discontinuation) is increasingly achievable in RA, prevalence differs between ACPA-negative (40%) and ACPA-positive RA (5-10%). Additionally, early DAS remission (DAS4months<1.6) is associated with achieving SDFR in ACPA-negative, but not in ACPA-positive RA. Based on these differences, we hypothesized that longitudinal patterns of local tissue inflammation (synovitis/tenosynovitis/osteitis) also differ between ACPA-negative and ACPA-positive RA patients achieving SDFR. With the ultimate aim being to increase understanding of disease resolution in RA, we studied MRI-detected joint inflammation over time in relation to SDFR development in ACPA-positive RA and ACPA-negative RA. Methods: A total of 198 RA patients (94 ACPA-negative, 104 ACPA-positive) underwent repeated MRIs (0/4/12/24 months) and were followed on SDFR development. The course of MRI-detected total inflammation, and synovitis/tenosynovitis/osteitis individually were compared between RA patients who did and did not achieve SDFR, using Poisson mixed models. In total, 174 ACPA-positive RA patients from the AVERT-1 were studied as ACPA-positive validation population. Results: In ACPA-negative RA, baseline MRI-detected inflammation levels of patients achieving SDFR were similar to patients without SDFR but declined 2.0 times stronger in the first year of DMARD treatment [IRR 0.50 (95% CI; 0.32, 0.77); P < 0.01]. This stronger decline was seen in tenosynovitis/synovitis/osteitis. In contrast, ACPA-positive RA-patients achieving SDFR, had already lower inflammation levels (especially synovitis/osteitis) at disease presentation [IRR 0.45 (95% CI; 0.24, 0.86); P = 0.02] compared with patients without SDFR, and remained lower during subsequent follow-up (P = 0.02). Similar results were found in the ACPA-positive validation population. Conclusion: Compared with RA patients without disease resolution, ACPA-positive RA patients achieving SDFR have less severe joint inflammation from diagnosis onwards, while ACPA-negative RA patients present with similar inflammation levels but demonstrate a stronger decline in the first year of DMARD therapy. These different trajectories suggest different mechanisms underlying resolution of RA chronicity in both RA subsets.
MeSH term(s)	Humans ; Arthritis, Rheumatoid/diagnostic imaging ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/complications ; Osteitis/drug therapy ; Tenosynovitis/complications ; Inflammation/diagnostic imaging ; Inflammation/drug therapy ; Inflammation/complications ; Antirheumatic Agents/therapeutic use ; Synovitis/diagnostic imaging ; Synovitis/drug therapy ; Synovitis/complications ; Magnetic Resonance Imaging
Chemical Substances	Antirheumatic Agents
Language	English
Publishing date	2022-05-12
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1464822-2
ISSN	1462-0332 ; 1462-0324
ISSN (online)	1462-0332
ISSN	1462-0324
DOI	10.1093/rheumatology/keac294
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Article ; Online: Relationship Between Middle Ear Volume and Long-term Audiological Outcomes in Congenital Aural Atresia Repair.

Imbery, Terence E / Maldonado, Michael / Mukherjee, Sugoto / Kesser, Bradley W

Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology

2019 Volume 40, Issue 6, Page(s) 782–788

Abstract: Objective: To assess the association of middle ear volume with long-term hearing outcomes in congenital aural atresia (CAA) repair.: Study design: Retrospective chart and radiological review.: Setting: Single academic tertiary referral center.: ... ...

Abstract	Objective: To assess the association of middle ear volume with long-term hearing outcomes in congenital aural atresia (CAA) repair. Study design: Retrospective chart and radiological review. Setting: Single academic tertiary referral center. Patients: Children and adults who underwent CAA repair between 1995 and 2016. Patients were divided into "best" and "worst" audiometric groups, based on stability of postoperative air conduction pure-tone average (AC PTA) results. Ten patients were included for study in the "best" group, and 12 in the "worst" group. Intervention(s): CAA repair. Main outcome measure(s): Long-term (> 1 yr) postoperative three-tone (500, 1000, 2000 Hz) AC PTA, speech reception threshold (SRT), air bone gap, and semiautomated calculated middle ear volume from preoperative computed tomography (CT) scans. Results: Statistically significant differences were noted between "best" and "worst" groups in AC PTA, SRT, and air bone gap (p < 0.001). Mean middle ear volume in the "best" group was 434.6 mm (range 326.3-602.1 mm) and 339.5 mm (range 199.4-502.1 mm) in the "worst" group (p = 0.02). The majority in both groups were right ears (p = 0.38), and males outnumbered females in the "best" group (9 out of 10; p = 0.018). Preoperative Jahrsdoerfer grading scores were similar between groups (p = 0.31). Mean follow-up for the "best" and "worst" groups was approximately 3.5 and 4.5 yr, respectively. Conclusions: For patients undergoing CAA repair, larger middle ear volume is associated with stable and better long-term audiometric outcomes.
MeSH term(s)	Adolescent ; Child ; Congenital Abnormalities/diagnostic imaging ; Congenital Abnormalities/physiopathology ; Congenital Abnormalities/surgery ; Ear/abnormalities ; Ear/diagnostic imaging ; Ear/physiopathology ; Ear/surgery ; Ear, Middle/diagnostic imaging ; Ear, Middle/physiopathology ; Ear, Middle/surgery ; Female ; Hearing/physiology ; Hearing Tests ; Humans ; Male ; Postoperative Period ; Retrospective Studies ; Tomography, X-Ray Computed ; Treatment Outcome
Language	English
Publishing date	2019-05-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	2036790-9
ISSN	1537-4505 ; 1531-7129
ISSN (online)	1537-4505
ISSN	1531-7129
DOI	10.1097/MAO.0000000000002233
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Article ; Online: Imaging of pediatric neurovascular emergencies.

Tang, Yang / Goodman, William C / Maldonado, Michael D / Du, Xinli

Emergency radiology

2018 Volume 25, Issue 3, Page(s) 227–234

Abstract: Pediatric strokes are rare but critical diagnoses to make in the emergency setting. They are associated with a set of pathologies that are not frequently encountered in the adult population. Some of these diseases have variable clinical presentations and ...

Abstract	Pediatric strokes are rare but critical diagnoses to make in the emergency setting. They are associated with a set of pathologies that are not frequently encountered in the adult population. Some of these diseases have variable clinical presentations and imaging appearance depending on the age of onset and severity of the underlying pathologies. This article reviews the differential diagnoses and noninvasive imaging evaluation of pediatric cerebral ischemic and hemorrhagic diseases.
MeSH term(s)	Cerebrovascular Disorders/diagnostic imaging ; Child ; Diagnosis, Differential ; Emergencies ; Humans ; Neuroimaging/methods
Language	English
Publishing date	2018-01-11
Publishing country	United States
Document type	Journal Article
ZDB-ID	1425144-9
ISSN	1438-1435 ; 1070-3004
ISSN (online)	1438-1435
ISSN	1070-3004
DOI	10.1007/s10140-017-1576-5
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Article ; Online: Isolated left upper eyelid ptosis with pansinusitis and contralateral otitis media in a 9-year-old boy.

Wilbanks, Nathan D / Filutowski, Oliver R / Maldonado, Michael D / Karcioglu, Zeynel A

American journal of ophthalmology case reports

2018 Volume 11, Page(s) 6–9

Abstract: Purpose: Upper eyelid ptosis has different etiologies in children and adults. In children, the common causes include orbital cellulitis, congenital ptosis, Cranial Nerve (CN) III palsy, and Horner's syndrome. The purpose of this report is to discuss an ... ...

Abstract	Purpose: Upper eyelid ptosis has different etiologies in children and adults. In children, the common causes include orbital cellulitis, congenital ptosis, Cranial Nerve (CN) III palsy, and Horner's syndrome. The purpose of this report is to discuss an unusual presentation of ptosis. Observations: We describe a case of a 9-year-old boy with left-sided ptosis with no apparent clinical signs of orbital or preseptal infection. Magnetic resonance imaging (MRI) revealed pansinusitis and contralateral otitis media with direct extension into the superior aspect of the left orbit affecting the levator palpebrae superioris muscle. Conclusions and importance: This finding on imaging disclosed the etiology of an otherwise unexplained case of upper lid ptosis.
Language	English
Publishing date	2018-04-21
Publishing country	United States
Document type	Case Reports
ISSN	2451-9936
ISSN (online)	2451-9936
DOI	10.1016/j.ajoc.2018.04.023
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Article ; Online: Abatacept increases T cell exhaustion in early RA individuals who carry HLA risk alleles.

Long, Sarah Alice / Muir, Virginia S / Jones, Britta E / Wall, Valerie Z / Ylescupidez, Alyssa / Hocking, Anne M / Pribitzer, Stephan / Thorpe, Jerill / Fuchs, Bryce / Wiedeman, Alice E / Tatum, Megan / Lambert, Katharina / Uchtenhagen, Hannes / Speake, Cate / Ng, Bernard / Heubeck, Alexander T / Torgerson, Troy R / Savage, Adam K / Maldonado, Michael A /

Ray, Neelanjana / Khaychuk, Vadim / Liu, Jinqi / Linsley, Peter S / Buckner, Jane H

Frontiers in immunology

2024 Volume 15, Page(s) 1383110

Abstract: Exhausted CD8 T cells ( ... ...

Abstract	Exhausted CD8 T cells (T
MeSH term(s)	Humans ; Abatacept/therapeutic use ; Abatacept/pharmacology ; Receptors, Immunologic/genetics ; Receptors, Immunologic/metabolism ; Arthritis, Rheumatoid/drug therapy ; Arthritis, Rheumatoid/immunology ; Arthritis, Rheumatoid/genetics ; Alleles ; Male ; Female ; CD8-Positive T-Lymphocytes/immunology ; CD8-Positive T-Lymphocytes/metabolism ; CD8-Positive T-Lymphocytes/drug effects ; Adult ; Lectins, C-Type/genetics ; Lectins, C-Type/metabolism ; HLA Antigens/genetics ; HLA Antigens/immunology ; Middle Aged ; Antirheumatic Agents/therapeutic use ; Genetic Predisposition to Disease ; T-Cell Exhaustion
Chemical Substances	Abatacept (7D0YB67S97) ; Receptors, Immunologic ; TIGIT protein, human ; KLRG1 protein, human ; Lectins, C-Type ; HLA Antigens ; Antirheumatic Agents
Language	English
Publishing date	2024-04-08
Publishing country	Switzerland
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2606827-8
ISSN	1664-3224 ; 1664-3224
ISSN (online)	1664-3224
ISSN	1664-3224
DOI	10.3389/fimmu.2024.1383110
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Article ; Online: Reply.

Fleischmann, Roy / Connolly, Sean E / Maldonado, Michael A / Schiff, Michael

Arthritis & rheumatology (Hoboken, N.J.)

2017 Volume 69, Issue 4, Page(s) 867–868

MeSH term(s)	Arthritis, Rheumatoid ; Biomarkers ; Humans ; Prognosis
Chemical Substances	Biomarkers
Language	English
Publishing date	2017-02-28
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.40021
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Article ; Online: Brief Report: Estimating Disease Activity Using Multi-Biomarker Disease Activity Scores in Rheumatoid Arthritis Patients Treated With Abatacept or Adalimumab.

Fleischmann, Roy / Connolly, Sean E / Maldonado, Michael A / Schiff, Michael

Arthritis & rheumatology (Hoboken, N.J.)

2016 Volume 68, Issue 9, Page(s) 2083–2089

Abstract: Objective: To assess the ability of a multi-biomarker disease activity (MBDA) test (Vectra DA) to reflect clinical measures of disease activity in patients enrolled in the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjects with ... ...

Abstract	Objective: To assess the ability of a multi-biomarker disease activity (MBDA) test (Vectra DA) to reflect clinical measures of disease activity in patients enrolled in the AMPLE (Abatacept Versus Adalimumab Comparison in Biologic-Naive RA Subjects with Background Methotrexate) trial. Methods: In the AMPLE trial, patients with active rheumatoid arthritis (RA) who were naive to biologic agents and had an inadequate response to methotrexate were randomized (1:1) to receive subcutaneous abatacept (125 mg every week) or subcutaneous adalimumab (40 mg every 2 weeks), with background methotrexate, for 2 years. The MBDA score was determined using serum samples collected at baseline, month 3, and years 1 and 2. The adjusted mean change from baseline in the MBDA score was compared between the abatacept and adalimumab treatment groups. Cross-tabulation was used to compare the MBDA score with the following clinical measures of disease activity: Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity Score in 28 joints using the C-reactive protein level (DAS28-CRP), and Routine Assessment of Patient Index Data 3 (RAPID-3). Results: In total, 318 patients were randomized to receive abatacept, and 328 were randomized to receive adalimumab; MBDA data were available for 259 and 265 patients, respectively. No association between the MBDA score and disease activity defined by the CDAI, SDAI, DAS28-CRP, or RAPID-3 in the abatacept and adalimumab treatment groups was observed. Conclusion: The MBDA score did not reflect clinical disease activity in patients enrolled in AMPLE and should not be used to guide decision-making in the management of RA, particularly for patients who receive abatacept or adalimumab as the first biologic agent.
MeSH term(s)	Abatacept/therapeutic use ; Adalimumab/therapeutic use ; Antirheumatic Agents/therapeutic use ; Arthritis, Rheumatoid/blood ; Arthritis, Rheumatoid/drug therapy ; Biomarkers/blood ; Humans ; Methotrexate ; Severity of Illness Index
Chemical Substances	Antirheumatic Agents ; Biomarkers ; Abatacept (7D0YB67S97) ; Adalimumab (FYS6T7F842) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2016-04-01
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	2756371-6
ISSN	2326-5205 ; 2326-5191
ISSN (online)	2326-5205
ISSN	2326-5191
DOI	10.1002/art.39714
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Article: Re-treatment with abatacept plus methotrexate for disease flare after complete treatment withdrawal in patients with early rheumatoid arthritis: 2-year results from the AVERT study.

Emery, Paul / Burmester, Gerd R / Bykerk, Vivian P / Combe, Bernard G / Furst, Daniel E / Maldonado, Michael A / Huizinga, Tom Wj

RMD open

2019 Volume 5, Issue 1, Page(s) e000840

Abstract: Objectives: To complete reporting of outcomes after total withdrawal of all rheumatoid arthritis (RA) therapy and re-treatment after flare in Assessing : Methods: Patients with early RA were initially randomised to double-blind, weekly subcutaneous ... ...

Abstract	Objectives: To complete reporting of outcomes after total withdrawal of all rheumatoid arthritis (RA) therapy and re-treatment after flare in Assessing Methods: Patients with early RA were initially randomised to double-blind, weekly subcutaneous abatacept plus methotrexate, or abatacept or methotrexate monotherapy. At month 12, patients with Disease Activity Score (DAS)28 C reactive protein (CRP) <3.2 had all RA treatments rapidly withdrawn and were observed for ≤12 months or until flare. After ≥3 months' withdrawal, patients with protocol-defined RA flare received open-label abatacept plus methotrexate for 6 months (re-treatment). Results: Proportion of patients in DAS28-CRP-defined remission remained numerically higher in original abatacept plus methotrexate and abatacept arms versus methotrexate arm up to day 253 of withdrawal. At the end of the withdrawal period, few patients remained in remission across all arms: 9/73 (12.3%), 7/50 (14.0%) and 6/53 (11.3%), respectively. For patients entering re-treatment, after 6 months' re-treatment, 95/124 (76.6%) and 78/124 (62.9%) patients achieved DAS28-CRP <3.2 and <2.6, respectively; mean changes in DAS28-CRP and Health Assessment Questionnaire-Disability Index scores from re-treatment baseline were -2.87 and 0.76, respectively. Re-treatment was well tolerated; exposure-adjusted infection rates per 100 patient-years were lower with abatacept plus methotrexate during withdrawal (7.2) and re-treatment (17.2) versus initial treatment periods of months 0-6 (116.6) and 6-12 (64.6). Conclusions: Most patients flared within 6 months of therapy withdrawal and few sustained major responses for 1 year. Re-treatment with abatacept plus methotrexate was effective and well tolerated in this controlled setting.
MeSH term(s)	Abatacept/administration & dosage ; Abatacept/adverse effects ; Abatacept/therapeutic use ; Adult ; Arthritis, Rheumatoid/diagnosis ; Arthritis, Rheumatoid/drug therapy ; Disease Progression ; Drug Therapy, Combination ; Female ; Humans ; Male ; Methotrexate/administration & dosage ; Methotrexate/adverse effects ; Methotrexate/therapeutic use ; Middle Aged ; Odds Ratio ; Prognosis ; Proportional Hazards Models ; Treatment Outcome
Chemical Substances	Abatacept (7D0YB67S97) ; Methotrexate (YL5FZ2Y5U1)
Language	English
Publishing date	2019-02-08
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2812592-7
ISSN	2056-5933
ISSN	2056-5933
DOI	10.1136/rmdopen-2018-000840
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Article: Efficacy of Abatacept and Adalimumab in Patients with Early Rheumatoid Arthritis With Multiple Poor Prognostic Factors: Post Hoc Analysis of a Randomized Controlled Clinical Trial (AMPLE).

Fleischmann, Roy / Weinblatt, Michael / Ahmad, Harris / Maldonado, Michael A / Alemao, Evo / Ye, June / Schiff, Michael

Rheumatology and therapy

2019 Volume 6, Issue 4, Page(s) 559–571

Abstract: Introduction: Patients with rheumatoid arthritis (RA) with poor prognostic factors, such as seropositivity for anti-citrullinated protein antibodies and early erosions, may benefit from early intensive treatment. However, information to guide physicians ...

Abstract	Introduction: Patients with rheumatoid arthritis (RA) with poor prognostic factors, such as seropositivity for anti-citrullinated protein antibodies and early erosions, may benefit from early intensive treatment. However, information to guide physicians on the best choice of therapy in these patients is limited. The objective of this study was to describe the efficacy of subcutaneous abatacept versus adalimumab over 2 years in patients with seropositive, erosive early RA in the AMPLE study. Methods: This exploratory post hoc analysis compared clinical, functional and radiographic outcomes in two subsets of patients: patients with early RA (≤ 6 months' disease duration) who were seropositive for rheumatoid factor and/or anti-citrullinated protein antibodies and had > 1 radiographic erosion (Cohort 1); and patients with RA and absence of ≥ 1 of these inclusion criteria (Cohort 2). Results: Of the 646 randomized patients, Cohort 1 included 38 patients receiving abatacept and 45 receiving adalimumab, and Cohort 2 included 280 patients receiving abatacept and 283 receiving adalimumab. Baseline demographics and disease characteristics were generally similar between treatment groups in both cohorts. Over 2 years, in Cohort 1, the adjusted mean change from baseline in the Disease Activity Score in 28 joints (using C-reactive protein) was numerically greater for abatacept than for adalimumab (mean difference at day 365 was 0.9, 95% confidence interval - 1.47 to - 0.33). Similar patterns of improvement were observed for other disease activity measures and physical function, but not for radiographic outcomes. No treatment-related differences were observed in Cohort 2. Conclusion: This analysis indicates a trend towards improved disease activity and physical function with abatacept versus adalimumab in patients with seropositive, erosive early RA. Trial registration: ClinicalTrials.gov NCT00929864. Funding: Bristol-Myers Squibb.
Language	English
Publishing date	2019-10-22
Publishing country	England
Document type	Journal Article
ZDB-ID	2783278-8
ISSN	2198-6584 ; 2198-6576
ISSN (online)	2198-6584
ISSN	2198-6576
DOI	10.1007/s40744-019-00174-7
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