Abstract：
:When patents expire, usually after 10 years in Germany, generic medicines routinely enter the market in place of conventional medications leading to significant reductions in prices. Currently the first biologicals are approaching patent expiry. Because of the biochemical complexities truly identical imitators are unrealistic. On the other hand, there is high socioeconomic pressure towards reduced cost of biologicals. In response to this situation the European Medicines Agency (EMA) has released a highly differentiated guidance document for the approval process of biosimilars. Biosimilars, which are already reality in other areas have to remain within a narrow biochemical variability corridor and are subsequently required to show bioequivalence to the reference product in both efficacy and safety in at least one large clinical phase III trial. In addition, post-marketing surveillance programs are mandatory in order to identify potential low frequency safety issues. In contrast to the "intended copies" used in some third world countries without such rigorous clinical testing the EMA-approved biosimilars are expected to have almost identical efficacy and safety as the reference medications. It is not yet clear how the use of specific biosimilars can be tracked and how uncontrolled exchange can be avoided. Nevertheless, biosimilars in rheumatology are likely to be available in the near future.
journal_name
Z Rheumatoljournal_title
Zeitschrift fur Rheumatologieauthors
Aringer M,Dörner Tdoi
10.1007/s00393-013-1140-ysubject
Has Abstractpub_date
2013-11-01 00:00:00pages
873-7issue
9eissn
0340-1855issn
1435-1250journal_volume
72pub_type
杂志文章abstract：:In recent years, new findings in immunology have been successfully converted to therapeutic principles, in particular for rheumatoid arthritis (RA) and spondylarthritides. The introduction of cytokine blockers in RA using tumor necrosis factor (TNF)-alpha and interleukin (IL)-1 inhibitors presented the first original ...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：10.1007/s00393-009-0436-4
更新日期：2009-07-01 00:00:00
abstract：:Biochemical studies of rats with mycoplasma arthritis revealed new findings in pathogenesis and pathophysiology. Preliminary examinations showed that mycoplasmas release specific endonucleases and exonucleases. In evaluating the isoenzymes of the lactate dehydrogenases, malate dehydrogenases as well as of the esterase...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1975-05-01 00:00:00
abstract：:The modified significance of radiological criterion in the new ACR/EULAR classification criteria for rheumatoid arthritis is based on the fact that the bone erosion seen using conventional radiology is the result of an already longstanding inflammatory process.In contrast, new imaging modalities such as magnetic reson...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：10.1007/s00393-011-0772-z
更新日期：2011-04-01 00:00:00
abstract：:The development of synovitis was studied in 64 rabbits with experimentally produced allergic arthritis and in 30 rabbits with experimentally produced non-allergic arthritis. The results are compared with the morphological changes of the synovial membrane in rheumatoid arthritis, especially in early stages, known from ...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：:Rheumatology training is reorganized with the implementation of the revision of the training regulations for German physicians (MWBO) to become a specialist in internal medicine and rheumatology. This article focusses on novel aspects including far-reaching waiver of reference numbers, the professionally recommended t...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：10.1007/s00393-020-00930-z
更新日期：2020-11-30 00:00:00
abstract：:Three new findings are reviewed that help to understand the mechanisms of action of anti-rheumatic gold drugs, such as disodium aurothiomalate (Na2Au(I)TM): i) We found that Na2Au(I)TM selectively inhibits T-cell receptor-mediated antigen recognition by murine CD4+ T-cell hybridomas specific for antigenic peptides con...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：
更新日期：1996-09-01 00:00:00
abstract：:Eight human femoral heads, surgically removed from patients with the clinical diagnosis: coxarthrosis or necrosis, were examined. In six of these we found severe arthrosis combined with synovitis and pannus formation. The pannus appeared as granulation tissue or fibrous connective tissue covering the surface of the ca...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1983-11-01 00:00:00
abstract：:Impaired host immunity has been regarded as a predisposing factor in post-primary tuberculosis in adults. Patients with systemic lupus erythematosus (SLE) are usually exposed to high doses of corticosteroids and eventually develop defective cellular immunity that increases the risk for active tuberculosis. SLE-associa...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：10.1007/s00393-003-0492-0
更新日期：2003-12-01 00:00:00
abstract：:T-Large Granular Lymphocyte (T-LGL) leukaemia is a rare clonal disease characterized by neutropenia and/or anaemia. Because of its strong association with rheumatoid arthritis (RA), T-LGL leukaemia is an important differential diagnosis to Felty's syndrome. This differentiation might be especially difficult since, in ...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：10.1007/s00393-005-0013-4
更新日期：2006-09-01 00:00:00
abstract：:The commission "Rehabilitation" of the German Society of Rheumatology compiled a data set for a routine report of the rehabilitation system for muskuloskeletal diseases. More than 250 rehabilitation hospitals offer inpatient rehabilitation for patients with musculoskeletal diseases. The prevalence of inpatient rehabil...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：10.1007/s00393-005-0626-7
更新日期：2005-06-01 00:00:00
abstract：:Rheumatoid arthritis (RA) represents an autoimmune disease affecting mostly joints, in particular small finger and toe joints. In addition RA can show extra-articular manifestations in many organs. Information on the frequency of extra-articular manifestations (EAMs) in RA varies greatly in different publications from...
journal_title：Zeitschrift fur Rheumatologie
pub_type：
doi：10.1007/s00393-011-0928-x
更新日期：2012-12-01 00:00:00
abstract：:The present study examined relations between irrational attitudes and pain experience in patients with rheumatoid arthritis (RA). 128 patients with definite RA from a rheumatic treatment center were studied by administration of the Irrational Attitudes Questionnaire (15) and a revised form of the Multidimensional Pain...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1990-05-01 00:00:00
abstract：:The sulfhydryl groups are chemically active parts of the protein molecule and participate in many important biochemical and metabolic processes. The present material comprised 132 patients with rheumatoid arthritis, 104 patients with other diseases and 44 controls. The patients with rheumatoid arthritis had decreased ...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1977-03-01 00:00:00
abstract：:A 74-year-old female patient with rheumatoid arthritis was diagnosed with Pneumocystis jiroveci pneumonia (PcP) following therapy with methotrexate and prednisone. Although bactrim treatment was initiated and PcP was not detected by a control bronchoalveolar lavage, the patient died. The precise cause of death remains...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：10.1007/s00393-005-0019-y
更新日期：2006-02-01 00:00:00
abstract：:Eight patients with SLE were found on clinical and roentgenological grounds or by respiratory function tests to have evidence of lung involvement. Great discrepancies were noted between clinical findings and the results of the respiratory function tests on the one hand and lacking or discrete radiological changes on t...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1976-03-01 00:00:00
abstract：:Three days after cholecystectomy, seven patients received a single dose of auranofin (5 tablets Ridaura = 4.35 mg gold). At defined time points thereafter the gold content in samples of blood, plasma, urine, bile, and feces was determined by instrumental neutron activation analysis (INAA). Maxima of the mean gold conc...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1991-01-01 00:00:00
abstract：AIM:The aim of this study was to compare demographic characteristics, disease activity, functional status, and quality of life between ankylosing spondylitis (AS) with neuropatic pain (NP) and AS without NP (Non-NP). METHODS:The MEDLINE via PubMed, Cochrane, Scopus, and Embase database, from the earliest available dat...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,meta分析
doi：10.1007/s00393-019-0654-3
更新日期：2020-02-01 00:00:00
abstract：:Involvement of the musculoskeletal system in 50 Lyme borreliosis patients seen in Czechoslovakia is described. Thirty-three patients reported tick bites or that they had removed a tick, four patients had been bitten by some other insect. Skin reaction following tick bite were found in 29 patients. Neurologic involveme...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1990-07-01 00:00:00
abstract：:To study the hormonal perturbations in FMS patients we injected sixteen FMS patients and seventeen controls a cocktail of the hypothalamic releasing hormones: Corticotropin-releasing hormone (CRH), Thyrotropin-releasing hormone (TRH), Growth hormone-releasing hormone (GHRH), and Luteinizing hormone-releasing hormone (...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：10.1007/s003930050242
更新日期：1998-01-01 00:00:00
abstract：:Polyarthralgias are widely common complaints. In earlier stages it might be difficult to state the right diagnosis. Differential diagnosis is absolutely necessary for starting in time with the right treatment. Out of a great clinical material the following diseases causing mono-, oligo- or polyarthralgia were discusse...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1982-01-01 00:00:00
abstract：:This paper concerns a radiological and postmortem study of an 81-year-old woman with diffuse intervertebral osteochondrosis (T12-L1 severe erosion) in association with generalized osteoarthritis and articular chondrocalcinosis. Varying degrees of cartilage plate flaws with cartilaginous Schmorl's nodes and vertebral p...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1979-11-01 00:00:00
abstract：:Ha(La)-antibodies are detected by counterimmunoelectrophoresis (CIE) in sera of systemic lupus erythematosus (SLE) patients, but not in sera of patients with progressive systemic scleroderma (PSS) (n = 38), rheumatoid arthritis (n = 91), ankylosing spondylitis (n = 97), and other rheumatic diseases (n = 452). This ant...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1988-03-01 00:00:00
abstract：:The neonatal lupus erythematosus syndrome, first described by McCuistion and Schoch in 1954, is associated with characteristic skin lesions and congenital heart block in the new-born, and the presence of Ro-(SSA), La-(SSB), or RNP antibodies in mothers and infants. A transplacental transference of maternal autoantibod...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：
更新日期：1989-03-01 00:00:00
abstract：:Inflammatory myopathies are as a rule rare diseases of skeletal muscle. In the majority of cases noninfective autoimmunological reactions are assumed. Only few diseases have an infectious origin. From a myopathological point of view, polymyositis must be selected from interstitial nodular myositis. The most important ...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1986-07-01 00:00:00
abstract：:Seronegative rheumatoid arthritis (RA) patients have increased proportions of OKT-4+ (helper) T cells and diminished proportions of OKT-8+ (suppressor/cytotoxic) T cells in the peripheral blood. This phenomenon corresponds to diminished inhibition of B cell activation by peripheral blood lymphocytes (PBL). Seropositiv...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：
更新日期：1984-05-01 00:00:00
abstract：:Low back pain (LBP) in patients with rheumatoid arthritis (RA) has so far been of little concern in clinical investigations. The main focus of scientific publications on spinal problems in RA was the cervical spine. In a recent study, we could demonstrate that LBP in RA patients leads to a significantly higher degree ...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：10.1007/s00393-017-0363-8
更新日期：2017-12-01 00:00:00
abstract：:Within the group of inflammatory rheumatic diseases, spondyloarthropathy is the most common diagnosis after rheumatoid arthritis. Its prevalence was long underestimated. Ankylosing spondylitis (AS) and undifferentiated spondyloathropathy (uSpA) are the most common subgroups in western countries. There are still diffic...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：10.1007/s003930200004
更新日期：2002-02-01 00:00:00
abstract：:The diagnosis of rheumatoid arthritis has been hampered by the lack of a truly disease-specific serologic marker. Thus, despite its moderate specificity rheumatoid factor (RF) is still the only established marker antibody for RA and among the diagnostic criteria of the American College of Rheumatology the only serolog...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：10.1007/s00393-002-0470-y
更新日期：2002-12-01 00:00:00
abstract：:Alopecia universalis is an advanced form of alopecia areata, characterized by complete loss of hair on all hair-bearing areas. It is currently believed to be an autoimmune disorder. The development of alopecia during treatment with tumor necrosis factor alpha (TNF-α) inhibitors is a rarely observed adverse event. This...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章
doi：10.1007/s00393-018-0464-z
更新日期：2018-06-01 00:00:00
abstract：:In order to reduce the prognostically relevant time interval between the initial manifestation of a rheumatic and musculoskeletal disease and diagnosis as well as the consecutive initiation of an appropriate treatment, several rheumatological centers in Germany have improved the access to initial rheumatologic evaluat...
journal_title：Zeitschrift fur Rheumatologie
pub_type： 杂志文章,评审
doi：10.1007/s00393-019-0683-y
更新日期：2019-10-01 00:00:00
