6ER-014 Patient-reported outcomes regarding adalimumab new formulation

Background Adalimumab is currently available in a 40 mg/0.4 mL formulation with fewer excipients, smaller volume and gauge needle, versus 40 mg/0.8 mL previous formulation. Purpose To evaluate injection site-related pain (ISRP) and satisfaction of new adalimumab formulation in comparison with the previous one. Material and methods Observational, prospective, analytical study (April to September 2017) in Outpatient Pharmacy Departments of two general hospitals. We selected patients on adalimumab treatment who changed old formulation to new formulation, and had been with the new one at least 2 months. Data collection interview comprised: sex, age, immune disease, old formulation treatment time, and a questionnaire about the person who administrates adalimumab, injection sites, warm-up drug before administration moment, ISRP with Visual Analogue Scale (VAS) and satisfaction with adalimumab’s new formulation. Data were analysed with SPSS ® v.21. Results Seventy-five patients were included, 46 (65.3%) males, mean age 49.8±13.5 years; 18 (24%) Chron’s disease, 18 (24%) psoriasis, 13 (17.3%) rheumatoid arthritis, 11 (14.7%) ankylosing spondylitis, six (8%) ulcerative colitis, five (6.7%) psoriatic arthritis and four (5.3%) uveitis; 49 (65.3%) were on treatment for more than 2 years with the old formulation, 11 (14.7%) between 1 and 2 years and 15 (20%) less than 1 year. Concerning drug administration: 56 (74.7%) auto-administration, 17 (22.7%) familiar support and two (2.7%) nurse support; 32 (42.7%) abdominal administration, 22 (29.3%) thighs’ administration, eight (10.7%) arms’ administration, 12 (16%) rotate between abdomen-thighs and one (1.3%) between abdomen-arms-thighs; 50 (66.7%) always warm up the drug before the administration, 11 (14.7%) sometimes and 14 (18.7%) never. About pain and satisfaction: 52 (69.3%) do not refer any ISRP (mean VAS=2±1.7), 65 (86.7%) refer less ISRP with the new formulation, seven (9.3%) refer the same ISRP and three (4%) more ISRP; 70 (93.3%) considered formulation improvement and 72 (96%) are totally satisfied with the new formulation. Chi-square test did not show statistically significant differences between ISRP absence and auto-administration (p=0.567), neither between warm up and ISRP absence (p=0.404), neither between satisfaction and ISRP absence (p=0.673). Conclusion The new adalimumab formulation was well tolerated and associated with less ISRP than the old formulation, therefore we expect that better adherence and persistence could also improve. We must develop new studies to evaluate these aspects. No conflict of interest