Session Information
Session Type: Abstract Submissions (ARHP)
Background/Purpose:
Methotrexate (MTX) is the cornerstone of rheumatoid arthritis (RA) treatment. Limitations of systemic exposure of oral MTX can affect its efficacy. Subcutaneous (SC) MTX improves bioavailability, which may result in better efficacy, and tolerability. Self-administration of SC MTX via conventional vial, needle, syringe (VNS) is challenging for some patients due to functional limitations, injection-site adverse events (AEs), and especially anxiety associated with pain. Use of SC MTX is limited to <5% of patients in the U.S. An analysis of literature from 1982-2012 on patient perception and experiences with self-administered medication for multiple diseases (RA, diabetes, hepatitis, multiple sclerosis) also suggests that anxiety associated with pain when using conventional VNS is often a barrier to use. Improvements in the delivery of SC MTX may alleviate anxiety associated with pain. In this study, the prototype of an investigational, first-in-class auto-injector (AI) for MTX is evaluated.
Methods:
This study compares administration-related pain and bleeding in healthy volunteers using conventional VNS and AI. 21 volunteers received 12 injections (6 with AI; 6 with VNS) of 1.0 mL saline administered by study personnel according to a randomized schedule. Pain was measured on a 20-point scale ranging from 0 (no pain) to 19 (extremely intense pain). Injection site bleeding was also assessed.
Results:
Pain was rated as none or faint for 78.4% of 125 AI administrations and 59.7% for 129 injections with VNS (Fishers Exact Text, P=0.0017). In addition, no pain was reported for 56.0% of AI administrations vs. 34.9% with VNS (P=0.0010) (Table). No pain scores >10 were reported for either treatment. No bleeding was observed in 89.7% of AI administrations vs. 79.2% of those with VNS (P=0.0069).
Table. Pain scores
|
Pain Score |
Auto-injector |
VNS |
|
0 |
56.0 |
34.9 |
|
1 |
22.4 |
24.8 |
|
2 |
6.4 |
6.2 |
|
3 |
5.6 |
17.0 |
|
4 |
3.2 |
6.2 |
|
5 |
2.4 |
3.9 |
|
6 |
0.8 |
1.5 |
|
7 |
2.4 |
2.3 |
|
8 |
0 |
2.3 |
|
9 |
0 |
0.8 |
|
10 |
0.8 |
0 |
|
>10 |
0 |
0 |
Conclusion:
Pain-related patient anxiety often associated with SC administration of medications is a potential cause for underutilization of SC MTX in the treatment of RA. By decreasing pain associated with self-injection, an AI may address issues of needle phobia and improve rates of utilization of SC MTX in patients who may benefit from this method of delivery.
Disclosure:
V. L. Ruffing,
None;
K. J. Dave,
Antares Pharma,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/pain-related-anxiety-as-a-barrier-to-use-of-methotrexate-in-rheumatoid-arthritis-comparing-conventional-vial-needles-and-syringe-with-an-investigational-auto-injector-in-healthy-volunteers/