Pain, acceptability, and local tolerability after i.d. and s.c. adalimumab administration
To quantify pain, visual analogue scores (VAS) using both a 10 cm visual analogue score (VAS) and the Dutch Faces Pain Scales Revised (FPSR) (15) for pain were completed by the volunteers at screening for the Mantoux, or saline if no Mantoux was given, at the time of drug administration, and after drug administration. Pain scores were obtained separately for insertion of the needle (insertion pain) and infusion of the formulation (infusion pain). A standardized injection site examination was performed to evaluate injection sites. Pain was graded as (0) Absent; (1) Present; no limitations in Activity of Daily Living (ADL); (2) Present; Limitations in age-appropriate instrumental ADL or requires repeated non-narcotic pain reliever (3) Present; Limitations in self-care ADL or interferes with sleep or requires repeated narcotic pain reliever. Induration was scored similarly as injection site pain, but with grade (3) instead being Limitations in self-care ADL or requires systemic treatment. Tenderness was graded as (0) Absent; (1) Mild discomfort with pressure; (2) Discomfort with touch; (3) Discomfort elicited by clothing or bed sheets. Pruritus was graded as (0) Absent; (1) Present, but minimally distracting; (2) Present, distracting during routine activities; (3) Interferes with sleep. Erythema, blister, ulceration, necrosis, and ecchymosis were measured if present.
Subject preference for injection was examined using multiple choice questions. Subjects were asked how they experienced the injections, how they would like to receive a potential future injection, and if they feared the injection(s), using the following options: Do you prefer the first injection, the second injection or do you not have a preference? Subjects were additionally asked whether they had fear or no fear. These questions were asked directly after injection, i.e., before subjects were able to see the injection, and one day after the injections.