Session Information
Date: Tuesday, October 23, 2018
Session Title: Patient Outcomes, Preferences, and Attitudes Poster II: Patient Perspectives
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: The offer of injectable MTX worldwide expanded during past few years with different types of enhanced devices such as prefilled syringes and autoinjector pens. SELFi trial intended to compare historical MTX prefilled syringes vs a new MTX autoinjector in terms of treatment adherence, functional capacity, and patients’ preference at 6 months in RA patients.
Methods: SELFi was a phase III, randomized open-label trial, conducted in France between Sept. 2015 and March 2017. It included RA patients, treated by oral or injectable MTX for ≥3 months in monotherapy or in association. Patients were randomized in two arms: MTX in prefilled syringes (PS) or MTX in autoinjectors (AI) at the dosage decided by the investigator. Primary co-criteria of the study were non-inferiority of AI vs PS in terms of patients’ compliance (measured by the investigator at each visit) and functional capacity (HAQ-DI) at 6 months. Secondary criteria included patients’ satisfaction and preference.
Results: Between Sept. 2015 and Sept. 2016, 50 rheumatologists, mostly with private practice, included 271 patients, 197 of which composed the per protocol population. Patients baseline characteristics were [mean (±SD)]: age: 59.2 (±12.3) yrs; BMI: 26.0 (±4.9) kg/m²; RA duration: 5.35 (±6.70) yrs; DAS28: 3.1 (±1.2); HAQ-DI: 0.6 (±0.6). All patients were treated by MTX (1/3 oral; 2/3 parenteral) at a mean dose of 15.4 (±4.1). There were no significant differences at baseline between PS and AI arms. Proportion of good compliers (>80%) was 89.9% vs 94.9% (AI vs PS): -5% [CI 95% -18.9%; 8.9%]. HAQ decreased by a mean of 0.06 in both groups. Percentage of change was 21.3% vs 22.4% (AI vs PS): -1.1% [-35.0%; 32.7%]. Due to the high data variability, the non-inferiority could not be proved in strict sense, but differences did not appear as relevant.
|
Patients’ reported satisfaction (Likert Scale) secondary criteria |
Easy to use |
Pleasant |
Satisfying |
Motivating for further utilization |
Reassuring |
Not constraining |
Not stressful |
Not painful |
|
AI / PS |
AI / PS |
AI / PS |
AI / PS |
AI / PS |
AI / PS |
AI / PS |
AI / PS |
|
|
Strongly agree |
60% / 21% |
7% / 0% |
63% / 21% |
61% / 35% |
30% / 14% |
51% / 36% |
55% / 41% |
51% / 38% |
|
Agree |
32% / 42% |
20% / 11% |
31% / 50% |
23% / 34% |
52% / 60% |
18% / 17% |
23% / 26% |
21% / 31% |
|
Neither agree nor disagree |
4% / 23% |
32% / 26% |
2% / 19% |
9% / 17% |
9% / 15% |
19% / 24% |
14% / 17% |
25% / 24% |
|
Disagree |
1% / 6% |
26% / 30% |
2% / 6% |
6% / 10% |
4% / 5% |
10% / 15% |
4% / 8% |
1% / 6% |
|
Strongly disagree |
4% / 8% |
14% / 33% |
1% / 4% |
1% / 4% |
5% / 6% |
2% / 8% |
8% / 9% |
1% / 1% |
|
Significance level |
p < 0.001 |
p < 0.001 |
p < 0.001 |
p = 0.001 |
p = 0.02 |
p = 0.02 |
p = 0.05 |
p = 0.15 |
Patients’ reported satisfaction was very significantly higher (p≤0.001) in AI arm vs PS for the following criteria: easy to use, pleasant, satisfying, willingness for further utilization and significantly higher (p<0,05) for reassuring and not constraining. Of the 132 patients who could try the both devices (during the study or in previous experiences), 127 (96%; p<0.001) preferred the autoinjector over the historical prefilled syringe. No unexpected safety issues were observed during this trial and injection point safety tolerance satisfaction was higher for AI vs PS.
Conclusion:
SELFi trial showed that although the non-inferiority of the new MTX autoinjector vs the historical prefilled-syringe was not proved in strict statistical sense, they seem comparable in terms of treatment compliance and functional capacity improvement. Besides the pen is significantly superior in terms of patients’ satisfaction and more than 95% of patients who have tried both devices declare preferring it over the syringe.
To cite this abstract in AMA style:
Saraux A, Hudry C, Zinovieva E, Courbeyrette A, Herman-Demars H. Patients Preference Goes to MTX Autoinjectors over Prefilled Syringes: Results from a Phase III Trial [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 10). https://acrabstracts.org/abstract/patients-preference-goes-to-mtx-autoinjectors-over-prefilled-syringes-results-from-a-phase-iii-trial/. Accessed January 15, 2021.« Back to 2018 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/patients-preference-goes-to-mtx-autoinjectors-over-prefilled-syringes-results-from-a-phase-iii-trial/