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Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study.

ABSTRACT: Glucocorticoids are the cornerstone treatment of polymyalgia rheumatica (PMR) but induce adverse events.To evaluate the efficacy and safety of first-line tocilizumab in PMR.In a prospective open-label study (ClinicalTrials.gov: NCT01713842), 20 glucocorticoid-free patients fulfilling Chuang's PMR criteria, with symptom onset within the last 12?months and a PMR activity score (PMR-AS) >10, each received three tocilizumab infusions at 4-week intervals, without glucocorticoids, followed by oral prednisone from weeks 12 to 24 (0.15?mg/kg if PMR-AS ?10 and 0.30?mg/kg otherwise). The primary end point was the proportion of patients with PMR-AS?10 at week 12.Baseline median PMR-AS was 36.6 (IQR 30.4-43.8). At week 12, all patients had PMR-AS?10 and received the low prednisone dosage. Median PMR-AS at weeks 12 and 24 was 4.5 (3.2-6.8) and 0.95 (IQR 0.4-2), respectively (p<0.001 vs baseline for both time points). No patient required rescue treatment. Positron emission tomography-CT showed significant improvements. The most common adverse events were transient neutropenia (n=3) and leucopenia (n=5); in one patient, the second tocilizumab infusion was omitted due to leucopenia.Tocilizumab monotherapy is effective in recent-onset PMR. Randomised controlled trials are warranted.NCT01713842.

SUBMITTER: Devauchelle-Pensec V

PROVIDER: S-EPMC4975852 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study.

Devauchelle-Pensec Valérie V Berthelot Jean Marie JM Cornec Divi D Renaudineau Yves Y Marhadour Thierry T Jousse-Joulin Sandrine S Querellou Solène S Garrigues Florent F De Bandt Michel M Gouillou Maelenn M Saraux Alain A

Annals of the rheumatic diseases 20160229 8

<h4>Background</h4>Glucocorticoids are the cornerstone treatment of polymyalgia rheumatica (PMR) but induce adverse events.<h4>Objectives</h4>To evaluate the efficacy and safety of first-line tocilizumab in PMR.<h4>Methods</h4>In a prospective open-label study (ClinicalTrials.gov: NCT01713842), 20 glucocorticoid-free patients fulfilling Chuang's PMR criteria, with symptom onset within the last 12 months and a PMR activity score (PMR-AS) >10, each received three tocilizumab infusions at 4-week in ...[more]

PMID: 26929219

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Project description:Background and aimComorbidities are known to exist in many rheumatological conditions. Polymyalgia rheumatica (PMR) is a common inflammatory rheumatological condition affecting older people which, prior to effective treatment, causes severe disability. Our understanding of associated comorbidities in PMR is based only on case reports or series and small cohort studies. The objective of this study is to review systematically the existing literature on the comorbidities associated with PMR.MethodsMEDLINE, EMBASE, PsycINFO and CINAHL databases were searched for original observational research from inception to November 2016. Papers containing the words 'Polymyalgia Rheumatica' OR 'Giant Cell Arteritis' OR the terms 'PMR' OR 'GCA' were included. Article titles were reviewed based on pre-defined criteria by two reviewers. Following selection for inclusion, studies were quality assessed using the Newcastle-Ottawa tool and data were extracted.ResultsA total of 17,329 papers were reviewed and 41 were incorporated in this review, including three published after the search took place. Wide variations were found in study design, comorbidities reported and populations studied. Positive associations were found between PMR diagnosis and stroke, cardiovascular disease, peripheral arterial disease, diverticular disease and hypothyroidism. Two studies reported a positive association between PMR and overall malignancy rate. Seven studies reported an association between PMR and specific types of cancer, such as leukaemia, lymphoma, myeloproliferative disease and specified solid tumours, although nine studies found either no or negative association between cancer and PMR.ConclusionQuantification of the prevalence of comorbidities in PMR is important to accurately plan service provision and enable identification of cases of PMR which may be more difficult to treat. This review highlights that research into comorbidities in PMR is, overall, methodologically inadequate and does not comprehensively cover all comorbidities. Future studies should consider a range of comorbidities in patients with a validated diagnosis of PMR in representative populations.

Dataset Information

Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study.

Publications

Efficacy of first-line tocilizumab therapy in early polymyalgia rheumatica: a prospective longitudinal study.

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