Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: Self-injection of subcutaneous (SC) golimumab (GLM) using an autoinjector device may be useful for patients with rheumatoid arthritis (RA), especially if they have functional impairment in the joints of the hand and fingers. An autoinjector designed to account for RA patient disability may improve patient satisfaction. The purpose of this study was to measure the acceptability, ease of use, and preferences for use of an autoinjector for SC GLM administration; effects of patient age and functional impairment were evaluated.
Methods: GO-MORE was an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ≥3.2). Patients self-injected 50-mg SC GLM once monthly for 6 months. At months 4 and 6, patients reported their use preferences and opinions of the autoinjector device on a questionnaire. Responses were analyzed descriptively. Effects of patient age and functional impairment on responses were evaluated.
Results: Overall, the vast majority of patients found the autoinjector to be easy to use, to cause mild or no discomfort, and to cause mild or no pain (table). At month 6, most of the efficacy-evaluable patients reported they preferred to self-inject in the thigh (75.2%; 1563/2077), followed by the abdomen (17.5%; 363/2077) and the upper arm (7.3%; 151/2077). More than 85% of patients indicated that they used their right hand for self-injection. More than 95% of patients were sure or very sure that when they used the autoinjector, the treatment had been fully injected; and 92.1% were satisfied or very satisfied with the monthly autoinjection frequency. Responses did not differ by patient age group. Patients with minimal or no functional impairment (HAQ-DI ≤0.5) at baseline tended to have more favorable responses, including greater ease of injection and less pain with injection, than those with functional impairment. At month 6, the overall self-injection experience was considered extremely favorable by 53.7% and favorable by 39.5% of patients without impairment and extremely favorable by 42.5% and favorable by 49.1% of patients with impairment.
Table. Patient Assessments of Autoinjector Use for SC GLM Delivery at Month 6
|
Overall Impression |
n (%) |
|
Impressions of Pain |
n (%) |
|
Ease of autoinjector use Extremely easy/easy Neither easy nor difficult Difficult/extremely difficult |
N=2089 1744 (83.5) 274 (13.1) 71 (3.4) |
|
Overall injection discomfort None/mild Moderate Severe/prohibitive |
N=2090 1983 (94.9) 96 (4.6) 11 (0.5) |
|
Overall impression of self-injection Extremely favorable/favorable Neither favorable nor unfavorable Unfavorable/extremely unfavorable |
N=2094 1922 (91.8) 151 (7.2) 21 (1.0) |
|
Pain/stinging upon injection None/mild Moderate Severe/prohibitive |
N=2092 1977 (94.5) 107 (5.1) 8 (0.4) |
Conclusion: Most patients had very favorable evaluations of the autoinjector device for GLM, reporting it to be easy to use, with minimal pain or discomfort upon injection and satisfactory administration frequency.
Disclosure:
H. Schulze-Koops,
Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nycomed, Pfizer, Roche, UCB,
5,
Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nycomed, Pfizer, Roche, UCB,
2,
Abbott, Actelion, Biotest, BMS, Chugai, Essex, GSK, MSD, Medac, Merck, Mundai Pharma, Novartis, Nycomed, Pfizer, Roche, UCB,
8;
R. Giacomelli,
None;
W. Samborski,
None;
S. Rednic,
None;
M. Herold,
None;
R. Yao,
Merck Sharp & Dohme,
3;
M. Govoni,
Merck Sharp & Dohme,
3;
N. Vastesaeger,
Merck Sharp & Dohme,
3;
H. Weng,
Merck Sharp & Dohme,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/patient-evaluations-of-subcutaneous-golimumab-delivery-by-autoinjector-smartject-for-treatment-of-rheumatoid-arthritis/