Academic Journal
Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial
| العنوان: | Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial |
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| المؤلفون: | Seror, Raphaèle, Baron, Gabriel, Hachulla, Eric, Debandt, Michel, Larroche, Claire, Puéchal, Xavier, Maurier, François, de Wazieres, Benoît, Quéméneur, Thomas, Ravaud, Philippe, Mariette, Xavier |
| بيانات النشر: | BMJ Publishing Group Ltd |
| سنة النشر: | 2014 |
| المجموعة: | HighWire Press (Stanford University) |
| مصطلحات موضوعية: | Clinical and epidemiological research |
| الوصف: | Objectives To evaluate the effect of adding a 10-week treatment of adalimumab to a standardised treatment with corticosteroids on the ability to taper more rapidly corticosteroid doses in patients with newly diagnosed giant cell arteritis (GCA). Methods Patients included in this double-blind, multicentre controlled trial were randomly assigned to receive a 10-week subcutaneous treatment of adalimumab 40 mg every other week or placebo in addition to a standard prednisone regimen (starting dose 0.7 mg/kg per day). The primary endpoint was the percentage of patients in remission on less than 0.1 mg/kg of prednisone at week 26. Analysis was performed by intention to treat (ITT). Results Among the 70 patients enrolled (adalimumab, n=34; placebo, n=36), 10 patients did not receive the scheduled treatment, seven in the adalimumab and three in the placebo group. By ITT, the number of patients achieving the primary endpoint was 20 (58.9%) and 18 (50.0%) in the adalimumab and placebo arm, respectively (p=0.46). The decrease in prednisone dose and the proportion of patients who were relapse free did not differ between the two groups. Serious adverse events occurred in five (14.7%) patients on adalimumab and 17 (47.2%) on placebo, including serious infections in three patients on adalimumab and five on placebo. Two patients died in the placebo arm (septic shock and cancer) and one in the adalimumab group (pneumonia). Conclusions In patients with newly diagnosed GCA, adding a 10-week treatment of adalimumab to prednisone did not increase the number of patients in remission on less than 0.1 mg/kg of corticosteroids at 6 months. Clinical trial registration number NCT00305539. |
| نوع الوثيقة: | text |
| وصف الملف: | text/html |
| اللغة: | English |
| Relation: | http://ard.bmj.com/cgi/content/short/73/12/2074; http://dx.doi.org/10.1136/annrheumdis-2013-203586 |
| DOI: | 10.1136/annrheumdis-2013-203586 |
| الاتاحة: | http://ard.bmj.com/cgi/content/short/73/12/2074 https://doi.org/10.1136/annrheumdis-2013-203586 |
| Rights: | Copyright (C) 2014, BMJ Publishing Group Ltd |
| رقم الانضمام: | edsbas.21E84FC3 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1136/annrheumdis-2013-203586 |
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