Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose
Methotrexate is the anchor drug used for the treatment of rheumatoid arthritis (RA). Despite its prominent position in RA therapeutics, its real-world effectiveness may be influenced by a relative lack of tolerability or other side effects that physicians may not be aware of but that are bothersome to patients.
Methods
We conducted a prospective, compensated ($25), online survey among RA patients who were members of Creakyjoints, a large arthritis patient community. Eligible participants must have recently initiated a new biologic, SQ MTX, or oral MTX in the last 12 months and were uniquely assigned to one of these 3 exposure cohorts. Patients eligible for more than 1 cohort were assigned in the hierarchy above. Results were stratified by exposure cohort: SQ MTX, oral MTX, and biologic. Descriptive statistics were used to compare patient-reported side effects and tolerability related to MTX use, comparing SQ vs. oral formulations and referent to biologic initiation. Recruitment is still ongoing to an expected sample size of 550 pts and results are reported through June 5th, 2014.
Results
A total of 783 patients were screened for the survey, and 346 were eligible. Of these, 287 (83.0%) completed the survey, distributed to the biologic (n=175, including 85 initiating SQ biologics), SQ MTX (n=33), and oral MTX (n=79). Demographics were similar across treatment arms; overall, mean (SD) age was 47.91 (13.01) years, 90.2% women. Commonly-reported side effects were included in the table and showed differences between exposure groups in diarrhea, nausea, fatigue, and other adverse events. Pain initiating SQ biologics compared to SQ MTX reported greater pain, particularly with SQ etanercept and adalimumab compared to SQ MTX. The mean pain score (0-10 scale) for patients on SQ MTX was 2.18, lower than mean score for etanercept (4.21, p = 0.002) and adalimuamb (4.43, p < 0.0001). Patients reported a monthly co-payment of $0 with the following frequencies: oral MTX - 13%, SQ MTX – 0%, and biologic users - 23%; and monthly co-payments between $0 and $25: oral MTX – 61%, SQ MTX - 61%, and biologics - 30%.
Conclusion
Results from this real-world RA patient cohort suggest that oral MTX is accompanied by many patient-reported side effects and tolerability problems that may be under-recognized by physicians. These may impact both treatment satisfaction and medication adherence that adding or switching to biologics or SQ MTX may attenuate.
Table: Patient Reported Side Effects and Tolerability Associated with use of Biologics and MTX
|
|
Biologic N=175 |
SQ MTX N=33 |
Oral MTX N=79 |
P value for |
|
Diarrhea |
6 (3%) |
3 (9%) |
17 (22%) |
<0.0001 |
|
Vomiting |
7 (4%) |
1 (3%) |
5 (6%) |
0.64 |
|
Other stomach problems |
13 (7%) |
2 (6%) |
4 (5%) |
0.77 |
|
Fatigue |
42 (24%) |
27 (82%) |
42 (53%) |
<0.0001 |
|
Malaise |
26 (15%) |
16 (48%) |
26 (33%) |
<0.0001 |
|
Mental fog |
26 (15%) |
13 (39%) |
21 (27%) |
0.002 |
|
Infection |
22 (13%) |
3 (9%) |
4 (5%) |
0.18 |
|
Any pain with injections |
83/99* (84%) |
20 (71%) |
N/A |
0.008 |
* limited to the 99 patients using SQ biologics
Disclosure:
J. R. Curtis,
Roche, Genentech, UCB Pharma, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie,
2,
Roche, Genentech, UCB Pharma, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie,
5;
D. Mackey,
None;
N. Gerber,
None;
A. Bharat,
None;
L. Chen,
None;
F. Xie,
None;
B. Nowell,
None;
K. G. Saag,
None;
S. Ginsberg,
None.
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