Session Information
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Patients with rheumatoid arthritis (RA) often receive methotrexate (MTX) in combination with biologics; however, MTX may be discontinued due to intolerance or to reduce the medication burden once disease control is achieved. Whereas previous studies have established the efficacy of tocilizumab (TCZ) initiated as monotherapy (MONO) for the treatment of RA,1,2 patient-reported outcomes (PROs) after MTX withdrawal in patients achieving good clinical response to TCZ + MTX have not been evaluated. PROs are important measures when determining response to therapy in patients with RA with respect to health-related quality of life (HRQOL).3,4 This study evaluated PROs between patients with RA who achieved low disease activity with TCZ + MTX and then continued or discontinued MTX in the COMP-ACT trial (NCT01855789).
Methods: US patients with RA who were inadequate responders to MTX were enrolled; initial combination therapy included MTX (≥ 15 mg/week orally) plus TCZ 162 mg subcutaneous either weekly (qw) or every 2 weeks (q2w). Patients who achieved DAS28-ESR ≤ 3.2 at Week 24 were randomized 1:1 to receive TCZ-MONO or continue TCZ + MTX until week 52 (double-blind). Changes in PRO scores were measured between Week 24 and Weeks 40 and 52, and included patient global assessment of disease activity (PtGA; visual analog score [VAS], 0-100 mm), pain (VAS), Health Assessment Questionnaire Disability Index (HAQ-DI, 0-3) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue.
Results: Of the 296 randomized patients (TCZ + MTX, n = 148; TCZ-MONO, n = 148), 74.8% were women, mean age was 55.5 years, mean RA duration was 6.8 years and mean DAS28-ESR was 6.3 at baseline. At Week 24 (randomization), PRO scores were similar between the randomized treatment groups. The mean changes in PtGA, pain, HAQ-DI and FACIT-fatigue scores from Week 24 to Weeks 40 were similar between the TCZ + MTX and TCZ-MONO groups (Table). The proportion of patients with HAQ-DI < 0.5 was similar between the groups at Week 24 (randomization), and remained similar at Weeks 40 and 52.
Conclusion: Patients receiving TCZ who discontinue MTX appear to have similar PROs across multiple measures compared with patients continuing TCZ + MTX. Differences observed in clinical parameters between TCZ-MONO and TCZ + MTX did not appear to achieve a threshold that would be considered clinically meaningful. Similarities in PROs on both treatments were consistent with the clinical efficacy measures previously reported from COMP-ACT.
References:
1. Jones G et al. J Rheumatol. 2017;44(2):142-6.
2. Dougados M et al. Ann Rheum Dis. 2013;72(1):43-50.
3. Deshpande PR et al. Perspect Clin Res. 2011;2(4):137-44.
4. Her M, Kavanaugh A. Curr Opin Rheumatol. 2012;24(3):327-34.
|
Table. Changes in Patient-Reported Outcomes from Week 24 (Randomization) to Week 40 and Week 52
|
|||
|
PRO Measure* |
TCZ + MTX n = 147 |
TCZ-MONO n = 147 |
Difference (95% CI) (TCZ-MONO minus TCZ + MTX)† |
|
Δ PtGA, mean (SEM) |
|
|
|
|
Week 24 to week 40 |
1.72 (1.79) |
5.95 (1.75) |
4.78 (-0.00, 9.56) |
|
Week 24 to week 52 |
-0.33 (1.77) |
3.58 (1.83) |
4.14 (-0.56, 8.84) |
|
Δ Pain, mean (SEM) |
|
|
|
|
Week 24 to week 40 |
1.64 (1.74) |
5.32 (1.61) |
4.19 (-0.23, 8.61) |
|
Week 24 to week 52 |
-0.05 (1.84) |
4.26 (1.68) |
4.69 (0.14, 9.24) |
|
Δ HAQ-DI, mean (SEM) |
|
|
|
|
Week 24 to week 40 |
0.01 (0.030) |
0.04 (0.034) |
0.03 (-0.05, 0.12) |
|
Week 24 to week 52 |
0.01 (0.028) |
0.02 (0.038) |
0.01 (-0.08, 0.10) |
|
Δ FACIT-Fatigue, mean (SEM) |
|
|
|
|
Week 24 to week 40 |
1.57 (0.67) |
-0.68 (0.64) |
-1.68 (-3.39, 0.02) |
|
Week 24 to week 52 |
1.30 (0.67) |
-1.12 (0.75) |
-1.82 (-3.69, 0.06) |
|
HAQ-DI < 0.5, n (%) |
|
|
|
|
Week 24 |
64 (43.5) |
56 (38.1) |
-5.4 (-16.7, 5.8) |
|
Week 40 |
60 (43.8) |
54 (40.6) |
-3.2 (-15.0, 8.6) |
|
Week 52 |
60 (46.9) |
53 (41.7) |
-5.1 (-17.3, 7.0) |
|
FACIT, Functional Assessment of Chronic Illness Therapy; HAQ-DI, Health Assessment Questionnaire Disability Index; PtGA, patient global assessment. † Estimated means from ANCOVA model includes Week 24 value as a covariate, treatment group, and the randomization stratification factors: DAS28 remission status at Week 24 (< 2.6, ≥ 2.6 to ≤ 3.2), baseline weight-by-dosing group (< 80 kg q2w, < 80 kg qw, 80 to < 100 kg q2w, 80 to < 100 kg qw, ≥ 100 kg qw), patient anti-TNF exposure (Yes or No). |
|||
To cite this abstract in AMA style:
Kremer J, Rigby WFC, Singer N, Birchwood C, Gill D, Reiss W, Best J, Pei J, Michalska M. Patient-Reported Outcomes Following Discontinuation of Methotrexate in Patients with Rheumatoid Arthritis Treated with Subcutaneous Tocilizumab: Results from a Randomized Controlled Trial [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/patient-reported-outcomes-following-discontinuation-of-methotrexate-in-patients-with-rheumatoid-arthritis-treated-with-subcutaneous-tocilizumab-results-from-a-randomized-controlled-trial/. Accessed .« Back to 2017 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/patient-reported-outcomes-following-discontinuation-of-methotrexate-in-patients-with-rheumatoid-arthritis-treated-with-subcutaneous-tocilizumab-results-from-a-randomized-controlled-trial/