Session Type: Abstract Submissions (ACR)
Background/Purpose: To evaluate drug survival, clinical response and predictors for drug survival for tocilizumab in patients with rheumatoid arthritis (RA) with inadequate response and/or adverse effects to previous treatment or contraindications to other medications in ordinary clinical practice, based on prospectively registered data from the Swedish biologics register, Anti-Rheumatic Therapies in Sweden (ARTIS).
Methods: All Swedish RA patients who had started treatment with tocilizumab from Sept, 2006 until March, 2012 were identified in ARTIS. Patients without DAS28 value at start and without known disease duration were excluded and were censored if the duration since the last follow-up extended 18 months. Clinical response was assessed by DAS28 and by EULAR response criteria. Kaplan Meier survival analyses with log-rank test and Cox Proportional Hazard Regression analyses were performed.
Results: 646 RA patients had started with tocilizumab of which 522, 81% were included in this report. 420 (80.5%) were females. The mean (SD) age, disease duration, HAQ, DAS28 and CRP at start was 57.8 (12.8) years, 14.2 (10.7) years, 1.4 (0.6) score, 5.4 (1.3) score and 27 (32) mg/L, respectively. 389 (75.5%) patients had seropositive RA. 185 (35.4%) were on monotherapy whereas 337 (64.6%) were treated with concomitant DMARDs of which 295 (56.5%) methotrexate (MTX). 325 (62.3%) were on corticosteroids. 63 (12%) patients were bionaïve, 278 (53.3%) were treated with ≥ 1 TNF-inhibitor, 126 (24.1%) ≥ 1 TNF-inhibitor and rituximab/abatacept and 49 (9.4%) with ≥ 1 TNF-inhibitor and rituximab and abatacept.
The overall 1 and 2-year estimated drug survival was 63% and 50%, respectively. 390 (74.7%) had ≥ 1 DAS28 value between 2.5 and 8 months follow-up, the first value was chosen. The percentages of EULAR Good/Moderate/No responders were 47.2/33.1/19.7%. 55% had DAS28 < 3.2 and 37% was in DAS28 remission. Univariate analyses revealed that men had significantly longer drug survival as compared to women (p=0.013). High CRP or ESR divided into quartiles were associated with longer drug survival, (p=0.0022 and p=0.013, respectively). Patients with HAQ <1.5 had longer drug survival compared to those with HAQ values ≥1.5 (p=0.014). Having been exposed to none or increasing number of biologics were associated with inverse drug survival (p=0.0002). Age, disease duration, seropositive RA, DAS28, being on MTX, on any DMARD or on steroids was not associated with drug survival. In the multivariate analysis with the above significant predictors as independent covariates, adjusted for age, the Hazard Ratios were: sex 0.79 (95% CI 0.52-1.19), HAQ 1.34 (95% CI 1.05-1.70), previous biologics 1.39 (95% CI 1.17-1.67) and CRP 0.80 (95% CI 0.69-0.91, per 1 SD change).
Conclusion: In this cohort of real-life patients with longstanding RA treated with tocilizumab the estimated 1-year drug survival was 63%, about 80% of the patients achieved a EULAR Good/Moderate response and drug survival was predicted by high CRP, low HAQ and no/low exposure of biologics. Treatment with concomitant MTX, DAS28, disease duration or age was not predictors for drug survival.
L. E. Kristensen,
L. T. Jacobsson,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/drug-survival-efficacy-and-predictors-for-survival-on-tocilizumab-in-real-life-patients-with-rheumatoid-arthritis-results-from-the-swedish-biologics-register/