Tocilizumab Real-Life Human Factors (RLHFs) Validation Study

Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the first unassisted use (Day 14) was reported.

Time frame: Day 14

Population: Safety Population; only those who performed the administration task(s) on Day 14 were included because the endpoint was not applicable to non-injecting participants. Here, n refers to number evaluable for the specified assessment, respectively.

Safety-critical tasks included those tasks where errors would have a reasonably foreseeable potential for clinical impact/harm, potentially resulting in direct physical injury to the user and/or conditions that require medical intervention. Safety-critical tasks included the following: release activation button; check the expiry date; inspect device prior to use; and inspect medication prior to use. Essential tasks included those essential to the execution of the injection. Essential tasks included the following: open the carton, remove the device and associated documents; remove cap; start an injection by depressing the needle-shield at the injection site and pressing the activation button; and hold the autoinjector until the complete dose has been delivered. The percentage of participants who successfully performed safety-critical and essential tasks during the second unassisted use (Day 28) was reported.

Time frame: Day 28

Population: Safety Population; only those who performed the administration task(s) on Day 28 were included because the endpoint was not applicable to non-injecting participants.

Ability to perform daily living activities was assessed across eight component sets including dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common activities. Twenty questions were scored on a 4-point Likert scale from 0 meaning without any difficulty to 3 meaning unable to do. The overall score was computed as the sum of domain scores divided by the number of domains answered. Therefore, the score range for HAQ-DI was the same as that of the individual questions, that is, from 0 to 3, where 0 indicates least difficulty and 3 indicates extreme difficulty. The mean change from baseline in HAQ-DI at each assessment was reported among participants with RA.

Time frame: Days 0, 14, 28

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, n refers to number evaluable for the specified assessment, respectively.

Injection pain was assessed on a categorical 6-point Likert scale, ranging from no pain to severe and intolerable. The percentage of participants was reported by response at each assessment timepoint among participants with RA.

Time frame: 0 and 15 minutes after injection on Days 0, 14, 28

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, n refers to number evaluable for the specified assessment, respectively.

Device satisfaction was assessed using twelve questions on a categorical 5-point Likert scale, ranging from strongly agree to strongly disagree. Question (Q) 1 (felt the autoinjection was easy to use), Q2 (felt comfortable while using the autoinjector), Q3 (felt the autoinjector was easy to hold), Q4 (able to tell when injection had completed), Q5 (felt he/she can inject properly with the autoinjector), Q6 (felt he/she had control over the injection process), Q7 (felt confident that he/she injected successfully), Q8 (felt it is easy to dispose of the autoinjector), Q9 (autoinjector would help to manage his/her injection schedule), Q10 (liked the look/feel of the autoinjector), Q11 (would recommend the autoinjector to someone else who needed to inject), Q12 (would continue having injections with the autoinjector). The percentage of participants was reported by response at each assessment among participants with RA, CGs, and HCPs.

Time frame: Days 0, 14, 28

Population: Safety Population. Here, n refers to number evaluable for the specified assessment, respectively.

Ancillary tasks included those tasks where the potential harm resulting from use error would be minor in severity, or the resultant harms were estimated to occur at sufficiently low levels. Ancillary tasks included the following: wash hands; clean the injection site with alcohol swab; wait for the alcohol to dry; dispose of the autoinjector cap; inspect full dose delivered after use; dispose of the autoinjector; and treatment of injection site after injection. The percentage of participants who succesffully performed ancillary tasks during the first (Day 14) and second unassisted use (Day 28) was reported.

Time frame: Days 14, 28

Population: Safety Population; only those who performed the administration task(s) were included because the endpoint was not applicable to non-injecting participants. Here, n refers to number evaluable for the specified assessment, respectively.

Sixty-six joints were assessed for swelling among participants with RA. The number of swollen joints at Baseline was reported.

Time frame: Baseline (Day 0)

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs.

Sixty-eight joints were assessed for tenderness among participants with RA. The number of tender joints at Baseline was reported.

Time frame: Baseline (Day 0)

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs.

Injection pain was assessed on a continuous 100-millimeter (mm) VAS, where 0 mm represents no pain and 100 mm represents unbearable pain. The mean VAS response at each assessment timepoint was reported among participants with RA.

Time frame: 0 and 15 minutes after injection on Days 0, 14, 28

Population: Safety Population; only participants with RA were included because the endpoint was not applicable to CGs and HCPs. Here, n refers to number evaluable for the specified assessment, respectively.