P332. Adherence to anti-tumor necrosis factor alpha therapies in inflammatory bowel diseases: Experience from four referral Italian centers
E. Angelucci1, M. Cesarini2, A. Cocco3, M.C. Di Paolo4, B. Galletti1, D. De Nitto1, G. Latella1, L. Tammaro4, R. Pica3, P. Vernia2, G. Frieri1
1University of L'Aquila, Italy; 2Sapienza University, Rome, Italy; 3Ospedale S. Pertini, Italy; 4Ospedale San Giovanni Addolorata, Italy
Background: Non adherence to long-term medical therapy occurs in 30–50% of chronic diseases [1] and in 5–60% of pts with IBD. Aim of this study was to assess adherence to scheduled administration of Infliximab (IFX, 5–10 mg/kg) and Adalimumab (ADA, 80–40 mg) in pts with Crohn's disease (CD) and ulcerative colitis (UC), from four Italian referral centres.
Methods: All pts receiving biologics were included in the study. Cause and length of delay/anticipation respect to scheduled administration were considered. Adherence to ADA was assessed using patient diaries. The mean duration of biological therapy was 16.5 months (1–61).
Patients: 136, 60M/76F, 110CD/26UC, mean age at diagnosis 32.4 (20–73) and at 1st administration 40.5 (16–78). IFX was administered to 93/136 pts (68.4%) and ADA to 43/136 (31.6%). Indications to biologicals were: steroid-dependence/resistance in 91/136 (66.9%), fistulae in 35/136 (25.8%), AZA failure in 6/136 (4.4%) others in 4/136 (2.9%). The overall number of administrations was 1763 (mean 12.9/pt, range1–73).
Results: A total of 187/1763 administrations (10.6%) in 45 pts (33%) was delayed [29 IFX (32.6%), 16 ADA (43.2%) (p = 0.3)]. The mean number of delayed administrations was 2.2 and the delay 13.7 days (1–35). Forgetfulness, summer holidays, pharmaceutical supply and intentional non adherence were responsible for 294 days delay (28 pts). Adverse events were responsible for 198 days delay (18 pts). A total of 82/1763 administrations (4.65%) were anticipated in 14 pts (13 on IFX – 92.8% – and 1 on ADA – 7.2% – p < 0.01), with a mean of 2.05 events/pt and an anticipation vs scheduled timing of 7.8 days (1–28). The reason for anticipation was related to practical issues in 19 (23.2%), occurrence of articular pain in 1 (1.2%) and lost response/active disease in 62 (75.6%) administrations. A clinical need and not a lack of adherence justify anticipation in these last 62 patients.
Conclusions: About 30% of patients failed to adhere strictly to scheduled treatment with biologics, in 10.6% of administrations. Possible consequences of reduced compliance remain to be assessed. Interestingly, in this study lack of adherence has been found also with agents which do not require daily and/or multiple administrations (features associated with low adherence in literature). No difference has been found between IFX and ADA in terms of decreased adherence.
1. World Health Organization. Adherence to long term Therapies. Evidence for action. 2003.