DISCONTINUATION RATE OF THE IST AND IIND ANTI-TUMOR NECROSIS FACTOR THERAPIES IN PATIENTS WITH RHEUMATOID ARTHRITIS IN ITALY
Author(s)
Leonardo Punzi, MD, Director1, Fabrizio Cantini, MD, Director2, Marco Matucci Cerinic, MD, PhD, Director of Division of Medicine and Rheumatology3, Clodoveo Ferri, MD, Professor4, Ugo Fiocco, MD, Ricercatore universitario confermato5, Michele Intorcia, MSc, Associate Director Outcomes Research, Italy6, Stefano Bombardieri, MD, Professor71Azienda Ospedaliera di Padova, Padova, Italy; 2 Ospedale Misericordia e Dolce, Prato, Italy; 3 University of Florence, Florence, Italy; 4 Università di Modena, Modena, Italy; 5 University of Padova, Padova, Italy; 6 Bristol-Myers Squibb, Rome, Italy; 7 Università di Pisa, Pisa, Italy
BACKGROUND: Anti-TNF therapies are efficacious in clinical trials for the treatment of RA. However, their long-term efficacy in daily practice in relation to the specific diagnosis or the use of concomitant DMARD therapy remains to be confirmed.OBJECTIVES: To estimate the proportion of patients with RA, treated with at least one anti-TNF therapy (infliximab [IFX], etanercept [ETN], or adalimumab [ADA]), who were still on the same biologic agent after 3 yrs (36 mths) of follow-up. To estimate the discontinuation rate of patients with RA, treated with the second anti-TNF therapy, after discontinuing the first one.METHODS: Patients attending participating centers who received their first anti-TNF treatment between July 1, 2002 and March 31, 2004, and who gave their consent, were invited to participate to the study. Pts were required to be ≥18 yrs old, with a diagnosis of RA (as defined by the ACR criteria). A total of 711 patients were enrolled in this retrospective cohort study involving a national representative sample of 23 rheumatology centers in Italy, selected according to both geography and treatment setting characteristics. A patient chart review was conducted to collect data on treatment duration, and a diary of therapies was completed. A Kaplan–Meier curve was calculated for each biologic anti-TNF therapy; the event was discontinuation of the drug due to inefficacy or toxicity.RESULTS: Pts’ baseline characteristics were: female 80.8%, mean age 53.3 yrs (range 18–84 yrs), mean duration of disease 9.4 yrs. Of 703 pts who met the inclusion criteria, 248 (35.3%) were treated with IFX, 259 (36.8%) with ETN and 196 (27.9%) with ADA. After a follow-up of 36 months, the discontinuation rate was 43.2% with IFX, 25.8% with ETN and 28.0% with ADA,. The discontinuation rate of IFX compared with ETN and ADA was statistically higher (p=0.0001 and p=0.0002, respectively). The difference between ADA and ETN was not statistically significant (p=0.826). Patients who discontinued the first agent and started the second one were 149: ETN 112, INF 12, ADA 25. After 24 months of follow up 78% patients on ETN, 46% on ADA and 25% on INF were still on the same agent. The RR of stopping the second agent increased by 31% (IC 95% 0,96 – 1,83)CONCLUSIONS: Our results show a higher discontinuation rate of anti-TNF therapies in daily practice in Italy compared with clinical trials. IFX was associated with a significantly higher rate of drug discontinuation than other anti-TNFs. Patients who stopped the first agent and switched to the second one had a discontinuation risk increase of of 31%. This results should be taken into account when first agent fails.
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
PMS62
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Musculoskeletal Disorders
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