Abstract:
OBJECTIVE:This post-hoc, pooled analysis of Phase 3 studies of tofacitinib examined the safety of tofacitinib 5 and 10 mg twice daily (BID) when used as monotherapy versus combination therapy with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in patients with rheumatoid arthritis (RA). METHODS:Pooled data from six double-blind, randomized controlled Phase 3 studies of tofacitinib 5 and 10 mg BID in patients with RA were analyzed for safety and stratified by administration as monotherapy (ORAL Solo: NCT00814307 and ORAL Start: NCT01039688) or in combination with csDMARDs (ORAL Sync: NCT00856544, ORAL Standard: NCT00853385, ORAL Scan: NCT00847613, and ORAL Step: NCT00960440), and by glucocorticoid use at baseline. Safety assessments included incidence rates (IRs) for serious adverse events (SAEs), discontinuations due to AEs, serious infection events, and herpes zoster (HZ), and were evaluated throughout the duration of the Phase 3 studies. RESULTS:In total, 3881 patients were included in the safety analysis (monotherapy studies: n = 1380; combination therapy studies: n = 2501). IRs for selected AEs of interest were generally numerically lower in patients who received tofacitinib 5 and 10 mg BID as monotherapy than as combination therapy (SAEs: IR [range] 6.21-6.72 versus IR 10.17-13.46; discontinuations due to AEs: IR 5.53-6.18 versus IR 10.80-11.01; serious infections: IR 1.57-1.66 versus IR 3.39-3.56; HZ: IR 1.95-2.93 versus IR 4.37-4.99, respectively), irrespective of tofacitinib dose or glucocorticoid use. There were too few patients and events within the placebo group to fully evaluate effect between combination therapy and monotherapy. CONCLUSIONS:Safety profiles were generally similar between patients receiving monotherapy and combination therapy; however, selected safety events of interest, including HZ and serious infections, showed lower IRs with non-overlapping 95% confidence intervals for tofacitinib all monotherapy versus combination therapy. Tofacitinib monotherapy may, therefore, have fewer safety events compared with combination therapy, and have a favorable risk-benefit profile in patients with active RA who are intolerant to csDMARDs.
journal_name
Semin Arthritis Rheumjournal_title
Seminars in arthritis and rheumatismauthors
Kivitz AJ,Cohen S,Keystone E,van Vollenhoven RF,Haraoui B,Kaine J,Fan H,Connell CA,Bananis E,Takiya L,Fleischmann Rdoi
10.1016/j.semarthrit.2018.07.006subject
Has Abstractpub_date
2018-12-01 00:00:00pages
406-415issue
3eissn
0049-0172issn
1532-866Xpii
S0049-0172(17)30815-6journal_volume
48pub_type
杂志文章,随机对照试验abstract:OBJECTIVES:The Dead Sea, the deepest and most saline lake on earth, has been known from biblical times for its healing properties. The aim of this systematic review was to present critically the level of evidence for the claims of therapeutic effects of Dead Sea treatments in several rheumatologic diseases and psoriasi...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2012.02.006
更新日期:2012-10-01 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:BACKGROUND:Conventional DXA imaging of spine and hip to measure bone mineral density (BMD) has limitations in patients with ankylosing spondylitis (AS). We investigated the correlation of hip and spine BMD measurements in patients with AS to determine if hip DXA will prove clinically useful while avoiding the confoundi...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2016.03.003
更新日期:2016-08-01 00:00:00
abstract:OBJECTIVES:To examine the efficacy and safety of recombinant human granulocyte colony-stimulating factor (rhG-CSF) and recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) for the treatment of severe neutropenia due to Felty's syndrome (FS) or systemic lupus erythematosus (SLE). METHODS:Eight ...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/s0049-0172(99)80040-7
更新日期:1999-10-01 00:00:00
abstract:OBJECTIVE:Localized scleroderma is a skin fibrosing disorder that, if untreated, may result in severe disability. The purpose of this systematic review is to compare the present evidence concerning the effectiveness of Methotrexate versus phototherapy, alone or associated with Psoralen, in childhood localized scleroder...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,meta分析
doi:10.1016/j.semarthrit.2018.03.003
更新日期:2018-12-01 00:00:00
abstract:INTRODUCTION:Immune checkpoint inhibitors (ICIs) are a class of cancer immunotherapy, increasingly utilized to treat malignancies. Inflammatory arthritis (IA) is a potential consequence of ICI use, but there is limited information to guide evaluation and management of this immune-related adverse event (irAE). This stud...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2018.02.011
更新日期:2018-12-01 00:00:00
abstract:OBJECTIVE:To review the use of liposomes as a delivery agent in inflammatory arthritis. METHODS:The literature on liposomes and liposomal drug delivery for the treatment of inflammatory arthritis was reviewed. A PubMed search of articles in the English-language journals from 1965 to 2007 was performed. The index words...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2008.08.004
更新日期:2009-12-01 00:00:00
abstract:OBJECTIVES:To review published data on the perioperative management of antirheumatic treatment and perioperative outcome in patients with rheumatoid arthritis (RA). METHODS:The review is based on a MEDLINE (PubMed) search of the English-language literature from 1965 to 2005, using the index keywords "rheumatoid arthri...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2006.10.003
更新日期:2007-04-01 00:00:00
abstract:OBJECTIVE:To evaluate the efficacy of colchicine in reducing the frequency of attacks in patients with PFAPA. STUDY DESIGN:We conducted a 6-month open label, randomized, controlled study among patients with PFAPA who attend the Pediatric Rheumatology Clinic at the Rambam Medical Center in Israel. A total of 18 patient...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2015.07.005
更新日期:2016-02-01 00:00:00
abstract::Rheumatoid arthritis (RA), once considered a benign and nonprogressive disease, is a debilitating condition with serious physical, emotional, and economic consequences. It afflicts approximately 1% of the adult population worldwide; prevalence increases with age, with twice as many women as men affected. In the United...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/0049-0172(91)90046-3
更新日期:1991-10-01 00:00:00
abstract:OBJECTIVE:To conduct a systematic review and meta-analysis of the prevalence, incidence, and medication treatment of depression and anxiety among patients with psoriatic arthritis (PsA). METHODS:We searched Medline, Embase, Cochrane Database of Systematic Reviews, CINAHL and PsycINFO for full-length studies that: util...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2020.02.001
更新日期:2020-12-01 00:00:00
abstract:PURPOSE:To describe the characteristics and outcome of patients with giant-cell arteritis (GCA)-related ophthalmologic involvement at diagnosis. METHODS:In a retrospective single-center cohort of 409 consecutive patients with GCA, we retrieved 104 patients with visual symptoms at GCA diagnosis and we compared them to ...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2019.09.008
更新日期:2020-04-01 00:00:00
abstract:BACKGROUND:General recommendations for a reference case for economic studies in rheumatic diseases were published in 2002 in an initiative to improve the comparability of cost-effectiveness studies in the field. Since then, economic evaluations in osteoarthritis (OA) continue to show considerable heterogeneity in metho...
journal_title:Seminars in arthritis and rheumatism
pub_type: 共识发展会议,杂志文章
doi:10.1016/j.semarthrit.2014.06.005
更新日期:2014-12-01 00:00:00
abstract:OBJECTIVES:To assess the prevalence and characteristics of severe pyogenic, nonpyogenic, and opportunistic infections in polymyositis and dermatomyositis (PM/DM) patients and to evaluate the predictive values for infections on clinical presentation and biochemical findings of PM/DM to detect patients at risk for such i...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2010.08.003
更新日期:2011-08-01 00:00:00
abstract:INTRODUCTION/OBJECTIVES:Pneumocystis jirovecii pneumonia (PJP) is a rare but potentially fatal opportunistic infection; however, consensus varies around which conditions or medications confer a level of risk sufficient to justify antibiotic prophylaxis for PJP. We used electronic health record (EHR) data to assess the ...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2018.10.018
更新日期:2019-06-01 00:00:00
abstract:OBJECTIVE:To report entry criteria and clinical features of patients with newly diagnosed and relapsing giant cell arteritis (GCA) enrolled in a randomized trial of tocilizumab, an interleukin-6 receptor-alpha inhibitor. METHODS:Newly diagnosed GCA was defined as diagnosis ≤6 weeks before baseline. Relapsing GCA was d...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.semarthrit.2016.11.002
更新日期:2017-04-01 00:00:00
abstract:OBJECTIVE:To examine immunogenetic and clinical features in a series of patients with the idiopathic tubulointerstitial nephritis and uveitis (TINU) syndrome diagnosed at the single referral hospital for a defined population in Southern Spain. PATIENTS AND METHODS:Retrospective study of the case records of all patient...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1053/sarh.2002.33718
更新日期:2002-10-01 00:00:00
abstract::Current interpretation of nailfold capillaroscopy is largely based on qualitative and subjective parameters. These parameters make the accurate assessment of the extent of the nailfold microangiopathy difficult. The authors present a comprehensive method in which several quantitative or semiquantitative parameters are...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/0049-0172(90)90091-s
更新日期:1990-08-01 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:OBJECTIVES:Dermatomyositis (DM) constitutes a subset of idiopathic inflammatory myopathies clinically characterized by proximal muscle weakness and skin involvement. Some of the dermatologic manifestations are highly prevalent and characteristic, but others such as generalized or limb edema are truly rare. The aim of t...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/j.semarthrit.2014.04.004
更新日期:2014-10-01 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
abstract:OBJECTIVE:The relationship between stiffness and quality of life (QoL) remains unclear. We therefore aimed to examine the role of pain and function in linking stiffness and QoL in patients with axSpA. METHODS:We used cross-sectional data from a registry of axSpA patients in a tertiary referral centre to assess the lin...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2019.02.010
更新日期:2019-12-01 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::Plant thorn synovitis (PTS) is an uncommon cause of monoarthritis. Seven cases of PTS were identified at our institution from January 1979 to July 1990, six of whom were men. Mean age was 27 years (range, 7 to 56 years). Symptoms included pain, swelling, and stiffness. Synovitis was present on examination along with d...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/0049-0172(91)90055-5
更新日期:1991-08-01 00:00:00
abstract:OBJECTIVES:To objectively measure physical activity levels in a cohort of juvenile dermatomyositis (JDM) patients; to compare physical capacity and health-related quality of life in JDM patients and their healthy controls (CTRL) matched by physical activity levels; and to associate physical activity variables with dise...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2016.03.010
更新日期:2016-08-01 00:00:00
abstract::Inequality of leg lengths is associated with low back pain, greater trochanteric bursitis, and degenerative hip disease. The pelvic obliquity that results from a discrepancy of leg lengths may contribute to degenerative changes in the lumbar spine. The diagnosis of leg length inequality may be overlooked. If this occu...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/0049-0172(88)90020-0
更新日期:1988-02-01 00:00:00
abstract::The early course of newly diagnosed RA among young adult patients (16-44 yr) is described from results of an ongoing study with a mean follow-up of 3.4 yr. Study diagnosis was based on the judgement of experienced rheumatologists, and data on several hundred variables were obtained on entry and annually for the purpos...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/0049-0172(76)90013-5
更新日期:1976-05-01 00:00:00
abstract:OBJECTIVE:To assess the long-term outcome of the synovitis, acne, pustulosis, hyperostosis, osteitis (SAPHO) syndrome. METHODS:All patients with the SAPHO syndrome seen at our unit between 1974 and 1997 were identified. Follow-up was prospective from 1992 to 1997. Data before 1992 were analyzed retrospectively. Clinic...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/s0049-0172(99)80027-4
更新日期:1999-12-01 00:00:00
abstract:OBJECTIVE:To assess the association between pseudotumor cerebri (PC) and systemic lupus erythematosus (SLE), and to seek a pathogenic mechanism that may elucidate the appearance of PC in patients with SLE. DATA SOURCE:Original English articles having the terms SLE, PC, or benign intracranial hypertension in their titl...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章,评审
doi:10.1016/s0049-0172(95)80023-9
更新日期:1995-10-01 00:00:00
abstract:BACKGROUND:The predominant forms of adult large vessel vasculitis (LVV) are giant cell arteritis (GCA) and Takayasu arteritis (TA). Cardiac involvement in LVV is a cause of morbidity and mortality, particularly in TA. Cardiac failure is most commonly secondary to uncontrolled arterial hypertension or myocardial ischaem...
journal_title:Seminars in arthritis and rheumatism
pub_type: 杂志文章
doi:10.1016/j.semarthrit.2017.03.023
更新日期:2017-10-01 00:00:00