BackgroundBaseline characteristics of patients from GiACTA trial have been recently reported at the ACR-2016 conference (1). GiACTA trial is a randomized, phase III controlled clinical trial evaluating the efficacy of tocilizumab (TCZ) in giant cell arteritis (GCA) (2). We had previously published a multicenter study on the use of TCZ in refractory GCA in a clinical practice setting (3).ObjectivesOur aim was to compare both studies, emphasizing on the baseline characteristics of the patients.MethodsComparative study between the GiACTA trial and our multicenter clinical practice study. In the latter, the diagnosis of GCA was established by the ACR-1990 criteria and in the GiACTA trial by the ACR modified criteria. In the clinical practice study, TCZ was used at standard IV dose (8 mg/kg/month), while in the GiACTA trial it was given subcutaneously (162 mg every 1 or 2 weeks, depending on the therapeutic arm). Quantitative variables were expressed as mean ± SD and were compared with the Student's t-test. Dichotomous variables were expressed as percentages and compared using the chi-square test.ResultsIn the GiACTA trial, 47.4% were newly diagnosed GCAs, while in the clinical practice study were all refractory to conventional treatment. The TABLE summarizes the main baseline characteristics of both studies. Compared with the GiACTA trial, in the clinical practice study were significantly greater: a) the mean time between the diagnosis of GCA and the onset of TCZ, b) the proportion of patients with polymyalgia rheumatica and ischemic optic neuritis, c) the proportion of positive PET/CT scans, d) the mean value of ESR, and e) the proportion of patients who had received conventional immunosuppressant agents (mainly MTX) before starting TCZ. There was also a significant lower proportion of sustained remission in the clinical practice study. When only GiACTA patients with relapsing-GCA were analyzed, these differences were maintained, except for the mean time from GCA diagnosis and the prevalence of ischemic optic neuropathy. Data on remissions were not available in this subgroup of GiACTA patients.ConclusionsPatients receiving TCZ in the clinical practice study have several baseline clinical and laboratory differences with regard to those included in the GiACTA trial and, therefore, data of this trial should be taken cautiously when applied in a real-world scenario.References Stone J et al. Arthritis Rheumatol.2016; 68 (suppl 10). http://acrabstracts.org/abstract/efficacy-and-safety-of-tocilizumab-in-patients-with-giant-cell-arteritis-primary-and-secondary-outcomes-from-a-phase-3-randomized-double-blind-placebo-controlled-trial/.Tuckwell K et al. Semin Arthritis Rheum. 2016 Nov 15. pii: S0049–0172(16)30275-X.Loricera J et al. Semin Arthritis Rheum. 2015; 44: 717–23. Disclosure of InterestNone declared
BackgroundNon-infectious aortitis is an inflammation of aortic wall which may be isolated or associated with a cluster of diseases.ObjectivesOur aim was to compare the clinical and laboratory findings of patients with isolated aortitis and patients with aortitis secondary to other underlying conditions.MethodsRetrospective study of 93 patients with non-infectious aortitis diagnosed by PET/CT scan from a referral center from January 2010 to December 2016. We have considered two groups: group a) isolated aortitis; and group b) secondary aortitis. Distributions of categorical variables were compared by the Pearson Chi2 or Fisher exact test. Quantitative variables were analyzing using the Student t test or Mann-Whitney U test as appropriate.ResultsNinety-three patients were diagnosed with non-infectious aortitis. One patient was excluded due to missing data. Group a) was composed by 54 patients (34 women/ 20 men) with a mean age of 67±11 years; group b) comprised 38 patients (28 women/ 10 men) with a mean age of 68±11 years. In this group, the underlying conditions we found were: giant cell arteritis (n=24), Takayasu arteritis (n=3), spondiloarthropathy (n=3), Sjögren's syndrome (n=3), ulcerative colitis (n=2), sarcoidosis (n=1), rheumatoid arthritis (n=1), polyarteritis nodosa (n=1). The comparative study between both groups is shown in the TABLE. Only inflammatory low back pain and polymyalgic syndrome yielded statistical signification.ConclusionsIn this study, we observed that both the presence of inflammatory low back pain and polymyalgic syndrome might have clinical relevance in the clinical suspicion of primary aortitis. However, larger studies are needed to corroborate these findings.Disclosure of InterestNone declared
BackgroundGiant cell arteritis (GCA) is often a disease refractory to corticosteroids and, besides, the efficacy of immunosuppressive agents is not well established. In recent years, several case reports and small case series have shown efficacy with the use of tocilizumab (TCZ).ObjectivesOur aim was to assess in a clinical practise setting the short and long-term efficacy of TCZ in GCA patients with refractory disease and/or with unacceptable side effects due to corticosteroids.MethodsRetrospective multicenter open-label study on 31 GCA patients treated with TCZ [intravenously at standard dose of 8 mg/kg/monthly (n=29), and subcutaneously at a dose of 162 mg/week (n=2)]. We assessed the efficacy on clinical and laboratory parameters, the reduction of the dose of corticosteroids, as well as the short and long-term side effects and the possibility of discontinuation or reduction of the dose of TCZ. Wilcoxon test was used to compare laboratory parameters across time.ResultsWe included 31 patients (24 women/ 7 men), with a mean age of 73±9 years. The main clinical features at TCZ onset were: polymyalgia rheumatica (n=21), asthenia (n=8), headache (n=8), constitutional syndrome (n=11), jaw claudication (n=3), and visual loss (n=4). Besides corticosteroids and before TCZ onset, 26 patients had also received several conventional immunosuppressive and/or biologic drugs. Twenty-seven of 31 patients achieved a rapid and maintained clinical improvement after TCZ therapy (Table). After a median follow-up of 18 [interquartile range, 6–30] months we observe a reduction of the median of: a) CRP from 1.9 [1.1–3.7] to 0.1 [0.1–0.7] mg/dL; b) ESR from 44 [17–74] to 12 [4–16] mm/1st hour; and c) the dose of prednisone from 20 [10–45] to 2.5 [0–7.5] mg/day. In this follow-up period, the outcome of patients was as follows: a) discontinuation of TCZ (n=8) due to sustained remission; b) dose reduction due to improvement (n=5) or side effects (n=2); c) withdrawal of TCZ because of side effects (n=7); and d) the same dose that at onset (n=8). The reasons why TCZ had to be discontinued were: severe neutropenia; recurrent pneumonia; colon adenocarcinoma; cytomegalovirus infection; hypertensive crisis during infusion; myelodysplastic syndrome; and overall health deterioration. The latter patient died because of stroke. Another patient also died after the second TCZ infusion due to stroke in the context of an infective endocarditis.ConclusionsTCZ therapy leads to a rapid and maintained improvement in patients with refractory GCA and/or with unacceptable side effects related to corticosteroids. However, the risk of neutropenia and infection should be kept in mind when using this biologic agent in patients with GCA.Disclosure of InterestNone declared
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