Abstract：
OBJECTIVES:Discuss issues regarding clinical trial design for the development of biosimilars in the European Union and the United States, with special focus on monoclonal antibodies used in the treatment of inflammatory diseases. METHODS:A search of the Internet as well as PubMed was conducted through June 2014 for information related to the clinical development of biosimilars using the keywords biosimilar, rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and ankylosing spondylitis. The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) websites were searched for biosimilar guidelines. RESULTS:The EMA began issuing draft guidelines for the development of biosimilars almost a decade ago and has approved numerous biosimilars. The US FDA has issued draft guidances providing stepwise considerations for the nonclinical and clinical development of biosimilars but has yet to approve a biosimilar under this pathway. CONCLUSIONS:Clinical trials aim to resolve uncertainties that may remain following nonclinical development regarding the similarity of the proposed biosimilar with the reference product. Pharmacokinetic and pharmacodynamic studies form the backbone of early clinical development and serve to inform phase 3 clinical development. Factors to be considered in clinical development include study population, design, end points, sample size, duration, and analytical methods.
journal_name
Semin Arthritis Rheumjournal_title
Seminars in arthritis and rheumatismauthors
Alten R,Cronstein BNdoi
10.1016/j.semarthrit.2015.04.002subject
Has Abstractpub_date
2015-06-01 00:00:00pages
S2-8issue
6 Suppleissn
0049-0172issn
1532-866Xpii
S0049-0172(15)00064-5journal_volume
44pub_type
杂志文章,评审abstract：OBJECTIVES:We describe the first case of adult-onset Still's disease (AOSD) presenting with trochleitis and successfully treated with an interleukin-1 receptor antagonist. METHODS:This is a descriptive case report of one patient, identified in consultation with the inpatient ophthalmology consult service. RESULTS:A 2...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2013.09.003
更新日期：2014-04-01 00:00:00
abstract：OBJECTIVES:To study the prevalence of connective tissue diseases (CTD) in patients with autoimmune hepatitis (AIH). METHODS:We identified 11 cases of AIH over the past 7 years at our institution, through a systematic chart review of patients with this diagnosis. Their charts were reviewed for the development of system...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2005.12.001
更新日期：2006-06-01 00:00:00
abstract：OBJECTIVE:To summarize the evidence about the relationship between polymyalgia rheumatica (PMR) and giant cell arteritis (GCA). METHODS:Review of relevant articles from the English-language literature. RESULTS:Epidemiologic studies suggest that PMR and GCA are closely related conditions affecting people over 50 years...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2003.09.008
更新日期：2004-04-01 00:00:00
abstract：OBJECTIVES:To report 3 cases ANCA-associated vasculitis (AAV) that developed in patients suffering from systemic sclerosis (SSc) and to review previously reported cases. METHODS:We describe 3 patients diagnosed with SSc who developed severe AAV that presented as crescentic glomerulonephritis (GN) and/or alveolar hemor...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2010.11.001
更新日期：2011-10-01 00:00:00
abstract：:PH is an uncommon manifestation of SLE. The symptoms of PH develop within a few years after the onset of the multisystem disease. The most common presenting complaints of SLE patients with PH are dyspnea on exertion, chest pain, nonproductive cough, edema, and fatigue or weakness. The important physical findings are a...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/0049-0172(84)90015-5
更新日期：1984-05-01 00:00:00
abstract：OBJECTIVE:Aging may be a risk factor for morbidity in anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). We compared the rate and better characterized the type of disease- and treatment-related complications affecting young and elderly patients with AAV. METHODS:All new cases of granulomatosis wi...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2020.02.008
更新日期：2020-12-01 00:00:00
abstract：:Twenty-two patients with rheumatoid arthritis, 3 with seronegative juvenile rheumatoid arthritis, 4 with systemic lupus erythematosus, and 4 with psoriatic arthritis have undergone therapeutic pheresis at our institution over the last 3 yr. Lymphoplasmapheresis appears to be the most effective form of pheresis in trea...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/0049-0172(80)90001-3
更新日期：1980-11-01 00:00:00
abstract：:A number of studies show the efficacy of methotrexate (MTX) for rheumatoid arthritis (RA) in general. However, is there any reason to single this drug out for early RA? Mechanistically, it probably works differently in RA than in cancer, at least in part. Thus, in addition to dihydrofolate reductase-related effects, M...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/0049-0172(94)90083-3
更新日期：1994-06-01 00:00:00
abstract：OBJECTIVES:To study the utility of lupus serology as a predictor for kidney graft outcome in (a) a systematic literature review (SLR) and (b) the Toronto lupus cohort (TLC). METHODS:For the SLR, a comprehensive literature search was performed to identify the articles reporting on the serology at renal transplantation ...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2016.09.008
更新日期：2017-06-01 00:00:00
abstract：:The myelodysplastic syndromes (MDS) are a group of therapeutically refractory anemias resulting from a clonal stem cell disorder often associated with cytogenetic abnormalities. Immunologic abnormalities and occasionally vasculitis have been reported although no series has characterized an associated arthritis. All ca...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/0049-0172(92)90035-c
更新日期：1992-06-01 00:00:00
abstract：OBJECTIVE:It is unclear whether the association between osteoarthritis (OA) and metabolic syndrome (MetS) varies with the site of the affected joint and the presence of pain. Our aim was to describe the association between MetS and radiographic OA (ROA) affecting the knee or the hand in the presence or absence of concu...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2018.07.007
更新日期：2019-04-01 00:00:00
abstract：:Macrophage activation syndrome (MAS) is a potentially life-threatening complication of systemic autoinflammatory/autoimmune diseases, generally systemic juvenile idiopathic arthritis and adult-onset Still's disease. It is characterized by an excessive proliferation of macrophages and T lymphocytes. Recent research rev...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2020.12.007
更新日期：2020-12-24 00:00:00
abstract：OBJECTIVE:To report a case of biopsy-verified Wegener granulomatosis (WG) with positive c-antineutrophil cytoplasmic antibodies who had evidence of spleen infarction and to review the relevant literature on spleen involvement in WG. METHODS:Descriptive case report of 1 patient with WG complicated by spleen infarction ...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2007.07.009
更新日期：2008-04-01 00:00:00
abstract：OBJECTIVE:To assess the impact of switching tumor necrosis factor (TNF)-alpha inhibitors on patients with axial spondyloarthritis (axSpA). METHODS:PubMed literature searches were conducted using combinations of search terms including ankylosing spondylitis, spondyloarthropathy, spondyloarthritis, switch/switching, dru...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2017.04.005
更新日期：2017-12-01 00:00:00
abstract：BACKGROUND:Autoimmune inner ear disease (AIED) was first described in 1979 and the disease has become more widely recognized over the last decade. Limited information is available regarding clinical features of the disease, disease course, and response to treatment. OBJECTIVE:To analyze data from 42 patients with docu...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2004.07.001
更新日期：2004-10-01 00:00:00
abstract：:Reproduction capacity and long-term preserved hormonal function are important aspects with big impacts on patients' quality of life. Updated information on the interaction between drug therapy and reproductive function is essential when discussing family planning with patients. Currently, limited data is published reg...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2018.01.006
更新日期：2018-10-01 00:00:00
abstract：OBJECTIVES:To identify and describe measures that can be used to assess the impact of psoriatic arthritis (PsA) on patient functioning and health-related quality of life (HRQOL). METHODS:A literature search of the PubMed database to identify papers describing assessment tools for quality of life and function in rheuma...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2008.01.003
更新日期：2009-02-01 00:00:00
abstract：:This study systematically reviewed commonly used patient-reported outcome measures (PROMs) for rheumatoid arthritis (RA), routinely collected in clinical practice, and evaluated objectives of their use. An additional survey conducted among identified RA registries provided additional information about collection of PR...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2018.03.006
更新日期：2018-12-01 00:00:00
abstract：OBJECTIVE:Several studies have found an increased fall risk in persons with osteoarthritis (OA). However, most prospective studies did not use a clinical definition of OA. In addition, it is not clear which factors explain this risk. Our objectives were: (1) to confirm the prospective association between clinical OA of...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2020.02.006
更新日期：2020-06-01 00:00:00
abstract：:Data from more than 100,000 patients in foreign and United States trials provide substantial evidence of diclofenac's safety and tolerability. Adverse experiences were infrequent and generally mild or transient. In United States short-term trials, the frequency and severity of side effects compared favorably with rate...
journal_title：Seminars in arthritis and rheumatism
pub_type： 临床试验,杂志文章
doi：10.1016/s0049-0172(85)80022-6
更新日期：1985-11-01 00:00:00
abstract：:In populations such as Northern Europeans in which the HLA-DR4 subtypes DW14 and Dw4 show strong association with rheumatoid arthritis (RA), these alleles and the double allelic dose of the shared epitope are considered severity markers. The clinical expression of RA varies in different populations, which may be deter...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/s0049-0172(95)80032-8
更新日期：1995-12-01 00:00:00
abstract：Objectives:To investigate the incidence of COVID-19 in a cohort of adult and paediatric patients with rheumatic diseases receiving targeted biologic and synthetic disease modifying anti-rheumatic drugs (tDMARDs) and to explore the possible effect of these treatments in the clinical expression of COVID-19. Methods:A cr...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2020.05.001
更新日期：2020-08-01 00:00:00
abstract：OBJECTIVE:To review the epidemiology, presentation, diagnosis, treatment, pathogenesis, and genetics of the syndrome known under the acronym of SAPHO for Synovitis, Acne, Pustulosis, Hyperostosis, and Osteitis to heighten awareness of this entity. METHODS:We conducted a Medline search using SAPHO syndrome, chronic rec...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2012.05.006
更新日期：2012-12-01 00:00:00
abstract：OBJECTIVE:The objective is to determine the relationship between clinical features and non-Hodgkin lymphoma (NHL) development in primary Sjögren's Syndrome (pSS), taking recently designed disease activity/severity scores into account. METHODS:Medical charts of pSS patients were retrospectively analyzed, scoring first ...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2013.03.001
更新日期：2013-10-01 00:00:00
abstract：:The beneficial effects of the anti-tumor necrosis factor (TNF) monoclonal antibodies infliximab and adalimumab and the soluble receptor fusion protein etanercept in the treatment of rheumatoid arthritis and a variety of other inflammatory disorders have been well described. However, less is known about the propensity ...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2005.01.005
更新日期：2005-04-01 00:00:00
abstract：:Our current hypothesis is that mechanical damage in the spine such as a disc prolapse can lead directly to pain. However, pain arising for this reason is usually of short duration. In many subjects, however, the mechanical problems lead to vascular damage and, in particular, venous obstruction and dilatation with endo...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/0049-0172(89)90020-6
更新日期：1989-05-01 00:00:00
abstract：:The efficacy and toxicity of cyclosporine in the treatment of patients with rheumatoid arthritis (RA) are reviewed. Most of the early trials were restricted to patients with intractable RA. The initial daily dose of cyclosporine was 5 to 10 mg/kg, which is now considered high. Of 283 cyclosporine-treated patients in n...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/0049-0172(92)90046-g
更新日期：1992-08-01 00:00:00
abstract：OBJECTIVE:We examined the treatment patterns among adults with rheumatoid arthritis (RA) and identified factors influencing access to traditional and biological disease modifying antirheumatic drugs (DMARDs). METHODS:We analyzed visits recorded in the National Ambulatory Medical Care Survey from 2005 to 2014 with a RA...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2017.10.011
更新日期：2018-04-01 00:00:00
abstract：OBJECTIVES:Air pollution ranks high among risk factors for the global burden of disease. The associations of air pollution and rheumatoid arthritis (RA) are controversial. This systematic review and meta-analyses has analyzed the association between outdoor air pollution and the development of RA. METHODS:PubMed, Emba...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章,评审
doi：10.1016/j.semarthrit.2019.10.005
更新日期：2020-04-01 00:00:00
abstract：OBJECTIVE:To ascertain the most reliable and relevant capillaroscopic measurements of nailfold videocapillaroscopy (NVC) by analyzing their inter- and intraobserver agreement and predictive value. METHODS:We studied 217 subjects (110 with Raynaud's phenomenon under ongoing evaluation, and 107 with connective tissue di...
journal_title：Seminars in arthritis and rheumatism
pub_type： 杂志文章
doi：10.1016/j.semarthrit.2007.10.008
更新日期：2009-02-01 00:00:00
