1 Department of Rheumatology, Dijon University Hospital, Dijon, 2 Department of Medicine and Rheumatology, J. Bouveri Hospital, Montceau les Mines, 3 Department of Rheumatology, Hôtel Dieu Hospital, Le Creusot, 4 Department of Rheumatology, G. Ramon Hospital, Sens and 5 INSERM/ERIT-M 0207, University of Burgundy, Dijon, France
Correspondence to: J. F. Maillefert, Department of Rheumatology, Hôpital Général, 3 rue du Fb Raines, 21000 Dijon, France. E-mail: jean-francis.maillefert{at}chu-dijon.fr
SIR, Anti-tumour necrosis factor (TNF-
) agents, such as infliximab, represent a major advance in rheumatoid arthritis (RA) and ankylosing spondylitis (AS) treatment. Infliximab is usually well tolerated but has some potential adverse effects, particularly infections [16]. The ageing process induces a decline in the function and control of the immune system. Thus, the prevalence of adverse effects of anti-TNF-
agents, and particularly of infections, might be increased in the elderly population. However, being elderly does not appear in most recommendations regarding the prescription of anti-TNF-
agents [7, 8]. This might be due to the fact that, to our knowledge, the elderly population has not been evaluated separately, although we have suggested in previous work that the prevalence of severe pyogenic infections might be greater in older than in younger infliximab-treated patients [6], and the mean age of patients developing severe infections was higher than the mean age of the whole group of patients treated with anti-TNF-
agents in Northern Ireland [9]. The aim of the present study was to evaluate the survival and the safety of infliximab in older patients in comparison with younger patients, using infliximab withdrawal and the reason for withdrawal as an outcome.
The Burgundian network includes the rheumatology departments of nine hospitals around the Burgundy area. All patients treated with infliximab for RA or AS in these departments are included in the cohort. The patients who started infliximab before November 2003 were included in the present study. The population was arbitrary split into two groups. Older patients were defined as those aged 70 yr or more at the date of starting infliximab. The other patients were classified as the younger patients. The endpoint was infliximab withdrawal. The drug survival of the two groups was evaluated using the KaplanMeier life table method, with 1 November 2003 as the censoring time, and compared using the log-rank test. Between-group differences were studied using one-way analysis of variance or Fisher's exact test. Similar analyses were performed in the subgroup of RA patients.
Informed patient consent and ethical approval were not obtained since the data obtained in this study were from a standardized follow-up developed in Burgundy in order to improve the quality of treatment and medical decisions.
Eighty-three patients (55 women, 28 men, mean age at start of infliximab 53.9 ± 13 yr) suffering from RA (60 patients) or AS (23 patients) were included. Infliximab was given at the recommended dose. During the follow-up (median = 1 yr), infliximab was withdrawn in 30 patients (36.1%) because of inefficacy (12 patients), adverse effects (12 patients, including four severe infections and six allergic reactions) and for miscellaneous reasons (six patients). Among the 83 patients, 11 were aged at least 70 yr (eight women, three men, mean age 75.7 ± 3 yr, range 7281 yr, all treated for RA). There were no between-group differences in the percentage of patients treated with corticosteroids, the mean prednisone daily dose, the mean methotrexate weekly dose (10.1 ± 5.4 vs 11.9 ± 5.7 mg, P = 0.4), the mean duration of follow-up (1.3 ± 1 vs 1.1 ± 0.8 yr, P = 0.3), the percentages of patients who stopped infliximab (36.4 vs 36.1%, P = 1) and the drug survival curves (Fig. 1). There was no difference in the percentage of patients who stopped infliximab for adverse effects (27.2% of older patients, 12.5% of younger patients, P = 0.19), inefficacy (0% of older patients, 16.7% of younger patients, P = 0.35) or allergic reactions (9.1% of older patients, 6.9% of younger patients, P = 0.59). However, there was a trend towards a greater percentage of patients who stopped infliximab for severe infections in the older patient group (18.2 vs 2.8%, P = 0.08). The analyses performed in RA patients were similar to those performed in the whole population.
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Acknowledgments
Acknowledgements are due to the head of the CHU Dijon, the Agence Régionale d'Hospitalisation de Bourgogne and to other rheumatologists in the Burgundian network: C. Bressot, A. Cherasse, M. Falconnet, L. Grimault, L. Julien, F. Marchand, S. Melac Ducamp, C. Piroth, J. F. Ramon, N. Richard and T. Saïdani.
There is no conflict of interest to declare.
References
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