Session Information
Date: Sunday, November 13, 2016
Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster I
Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: When a tumor necrosis factor inhibitor (TNFi) fails in a patient with moderate to severe rheumatoid arthritis (RA), new American College of Rheumatology (ACR) guidelines recommend a switch to either another TNFi or a non-TNFi biologic. The aim of this study was to evaluate disease activity and patient-reported outcomes (PROs) in RA patients who switched to etanercept after adalimumab failure.
Methods: Adults (age ≥ 18 years) with moderate to severe RA (disease activity score using 28-joint count and C-reactive protein ≥ 3.2) who failed to respond (1º failure) or lost a satisfactory response (2º failure) to adalimumab treatment, based on ACR20% improvement criteria (ACR20) or investigator judgment, were enrolled in an open-label, multicenter, single-arm study. After ≥ 2 weeks of washout for patients on adalimumab, etanercept 50 mg once weekly for 24 weeks was added to ongoing methotrexate treatment. Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire (HAQ) disability index (DI), and pain visual analog scale (VAS) were evaluated at weeks 0, 4, 8, 12, 18, and 24. Other PROs including Medical Outcomes Short Form 36 (SF‑36) and Work Productivity and Activity Impairment (WPAI) were assessed at weeks 0, 12, and 24. The primary efficacy endpoint (ACR20 at week 12) and safety data from this study were presented previously; this analysis focused on PROs at each visit.
Results: Of 85 patients studied (80% women; mean age 56.6 years), 84 were evaluable for efficacy. After being switched from adalimumab to etanercept, clinical outcomes and PROs improved from baseline at each study visit (Table). Improvement in mean HAQ DI (–0.31 points from baseline to week 24) exceeded the minimal clinically important difference of 0.22 points. Mean improvement in HAQ DI from baseline to week 24 by adalimumab failure and anti-adalimumab antibodies was –0.05 (1º failure, antibodies; n = 7), –0.65 (2º failure, antibodies; n = 17), –0.15 (1º failure, no antibodies; n = 22), and –0.37 (2º failure, no antibodies; n = 33). Improvements in other PROs (HAQ pain VAS, SF-36 physical function, and WPAI absenteeism/presenteeism) also were greatest for patients with 2º adalimumab failure and anti-adalimumab antibodies. Adverse events were consistent with the known safety profile of etanercept.
| Table. Clinical Outcomes and PROs by Study Visit After Switching to Etanercept (N = 84) | ||||||
| Outcome |
Baseline |
Week 4 |
Week 8 |
Week 12 |
Week 18 |
Week 24 |
| % with ACR20 response |
– |
19.0% |
29.8% |
35.7% |
31.0% |
34.5% |
| Mean CDAI |
43.7 |
33.0 |
30.5 |
28.7 |
28.6 |
26.1 |
| Mean HAQ DI |
1.52 |
1.25 |
1.24 |
1.25 |
1.24 |
1.21 |
| Mean HAQ pain VAS |
63.2 |
50.3 |
42.8 |
44.0 |
45.8 |
40.6 |
| Mean SF-36 physical function* |
31.4 |
– |
– |
35.9 |
– |
36.5 |
| WPAI, % work missed† |
15.3% |
– |
– |
9.5% |
– |
5.5% |
| WPAI, % impairment working† |
41.6% |
– |
– |
29.2% |
– |
25.8% |
| WPAI, % activity impairment |
57.9% |
– |
– |
43.2% |
– |
40.0% |
| * For SF-36 physical function, increased scores indicate improved health; for all other PROs, decreased scores indicate improved health † Among employed patients (n = 41) | ||||||
Conclusion: Clinical outcomes and PROs improved from baseline at every visit when RA patients switched to etanercept after adalimumab failure, particularly among those with anti-adalimumab antibodies and 2º loss of response to adalimumab. Limitations were small subgroup sample sizes, analysis of secondary endpoints, and lack of long-term outcomes after 24 weeks (6 months).
To cite this abstract in AMA style:
Bessette L, Khraishi M, Kivitz AJ, Kaliyaperumal A, Grantab R, Poulin-Costello M, Isaila M, Collier D. Patient-Reported Outcomes for Etanercept Therapy in Adult Patients with Moderate to Severe Rheumatoid Arthritis Who Failed Adalimumab Treatment [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/patient-reported-outcomes-for-etanercept-therapy-in-adult-patients-with-moderate-to-severe-rheumatoid-arthritis-who-failed-adalimumab-treatment/. Accessed December 5, 2020.« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/patient-reported-outcomes-for-etanercept-therapy-in-adult-patients-with-moderate-to-severe-rheumatoid-arthritis-who-failed-adalimumab-treatment/