P406 Adherence, acceptability and serum trough concentration of adalimumab autoinjector in quiescent patients with inflammatory bowel diseases

S. Kato, N. Yamaga, A. Ishibashi, K. Kani, S. Nagoshi

Department of Gastroenterology and Hepatology, Saitama Medical Centre- Saitama Medical University, Kawagoe City, Saitama, Japan

Background

Anti-TNF α antibodies have contributed to the good prognosis in patients with inflammatory bowel diseases (IBDs). Adherence of these drugs affects the treatment effects in patients with IBDs. Recently, the use of an adalimumab (ADA) autoinjector (AI) was approved in Japan. However, the effects of the use of this AI in patients with IBDs are not clear. We elucidated whether the use of an AI for ADA administration improves the adherence to and acceptability of ADA therapy compared with the use of syringe (SYR) type.

Methods

This was a single-centre prospective observational study approved by the institutional review board of our hospital. Twenty-six quiescent IBD patients, including ulcerative colitis and Crohn’s disease, treated by administration of ADA 40 mg using SYR every other week for >6 months or naive to ADA were enrolled in this study. The patients administered treatment using SYR were switched to an AI. The AI-naive and AI-switched patients were administered ADA treatment using AI for 6 months. The levels of adherence and acceptability, including pain and satisfaction levels, were measured using the visual analogue scale before and after treatment with ADA administered using AI. Serum ADA trough levels were also examined.

Results

Of the 26 enrolled patients, 1 with selection error, 1 with a rejection of approval and 2 with recurrence were excluded. In total, 24 participants were included in the final analysis. The mean (SD) age of the participants was 12.6 (8.4) years. Of the participants, 54.5% (12/22) were male, 68.2% (15/22) had ulcerative colitis, 27.3% (6/22) used thiopurine and 77.35 (17/22) were administered treatment using SYR. The adherence rate improved after switching to AI. The adherence rate of patients who received maintenance ADA was not significantly different from that of the ADA-naive patients (SYR type: 89.1 ± 12.7 mm, AI-switch: 94.0 ± 8.6 mm, AI-naive: 87.0 ± 21.6 mm, not significant [NS]). According to the acceptability of ADA AI, the pain intensity significantly decreased after switching. It was also significantly lower in the AI-naive group than in the SYR group (SYR: 55.0 ± 24.8 mm, AI-switch*: 87.3 ± 15.4 mm, AI-naive*: 92.2 ± 10.1 mm, *p < 0.01 compared with SYR). The level of satisfaction significantly increased after switching (SYR: 62.6 ± 27.9 mm, AI-switch*: 85.9 ± 12.5 mm, AI-naive: 81.2 ± 20.9 mm; *p < 0.01, compared with SYR). The ADA trough level was not significantly different after switching (SYR: 11.0 ± 9.1 mg/ml, AI-switch: 9.9 ± 5.5 mg/ml, NS).

Conclusion

ADA administration using AI resulted in significantly improved acceptability without changes in serum ADA trough levels.