Name: Jansen Giesen Falcão
Type: MSc dissertation
Publication date: 21/08/2017
Advisor:
Name |
Role |
|---|---|
| Valéria Valim Cristo | Advisor * |
Examining board:
| Name |
Role |
|---|---|
| David Jamil Hadad | Internal Alternate * |
| Eliana Zandonade | External Examiner * |
| Maria Bernadete Renoldi de Oliveira Gavi | Internal Examiner * |
| Valéria Valim Cristo | Advisor * |
Summary: OBJECTIVE: To compare different strategies of switching to a second biological therapy in Rheumatoid Arthritis (RA) in patients from BIOBADABRASIL register.
METHODS: Data from a population-based cohort including 1,109 patients with RA according to American College Rheumatology / European League Against Rheumatism (ACR/EULAR) 2010. Patients were followed from beginning of the first biologic therapy up to 7 years (2009-2015). Sex, age, disease duration, DAS 28 and concomitant treatments at baseline were considered. Kaplan-Meier estimates, Chi-square, Kruskal-Wallis and Wilcoxon-Mann-Whitney tests, Cox regression analysis were applied when appropriate. Results were expressed as mean ± SD and %(n). Small sample size precluded the inclusion of Golimumab (GOLI) and Certolizumab (CERTO) in the survival analysis.
RESULTS: From all, 85% were women, mean age of 50 years and disease duration of 11 years. Rheumatoid Factor (RF) was positive in 87%, DAS 28 5.36 ±1.35, 76% using corticoid and 71% taking Methotrexate (MTX). Ninety one percent started Anti- Tumor Necrosis Factor (Anti-TNF), as followed: Adalimumab (ADA) 33% (370), Infliximab (INF) 32 % (356), Etanercept (ETA) 23% (258), Tocilizumab (TOCI) 3% (35), Golimumab (GOLI) 2% (19), Certolizumabe (CERTO) 1% (9), Abatacept (ABA), 1% (14) e Rituximab (RTX) 4% (48).
Considering first treatment, survival of non anti-TNF (58.50 ± 3.46; 95%CI 51.71 65.28) was higher than anti-TNF (53.43 ± 1.21; 95%CI 51.05 55.77), p=0.042. Tocilimumab (TOCI) showed higher survival (57.22 ± 4.57; 95%CI 48.27 66.17) when compared to anti TNF (53.41±1.21; 95%CI 51.05 55.77); p=0.023. Only 32.28% (358) switched to a second biological therapy. 65.92% (236) switched from anti-TNF to anti-TNF (ETA=105, ADA=83, INF=33, others anti-TNF=15); 27,93% (100) switched from anti-TNF to non anti-TNF (RTX=38, TOCI=32, ABA=30) and few 6,13% (22), from non anti-TNF to any class. 336 patients who started using anti-TNF (INF= 140, ADA=120, ETA=69) and switched to a second biological therapy were included for survival analysis. The best switching strategy was from anti-TNF to non anti-TNF: 50.72 ± 3 months (CI95% 44.84-56.60) versus 44.67±2.46 months (CI95% 39.85-49.49), p=0.010. Even using less corticoid and showing higher DAS 28 in the beginning of treatment, patients who changed from anti TNF to TOCI achieved better survival (55.80 ± 4.74; CI95% 46.51-65.09 months, p=0.029) compared to ETA (50.06 ±3.61; IC 95% 42.99-57.14), RTX (47.75 ± 4.93; CI95% 38.10-57.40), ABA (44.89±5.94; CI95% 33.25-56.53), ADA (39.45±3.89; CI95% 31.83-47.08) and INF (34.43±4.65; CI95% 25.31-43.55). The reasons for switching were inefficacy or loss of efficacy (64%, n = 216), adverse effects (26%, n=87), and others (10%, n = 33). When the reason for switching was adverse effects, the best option was a non anti- TNF with 50.29 ± 4.93 months (95%IC=40.62 59.95) versus 43.23 ± 4.22 months (95%IC= 34.96 51.51), p=0.038.
CONCLUSION: The anti-TNF is the most prescribed drugs at BIOBADABRASIL register as first and second biological therapy. The option for a non anti TNF as first biological therapy showed better survival. Switching from anti-TNF to non anti-TNF was better too. TOCI was the drug with better survival as second biological therapy. The main reason for switching was inefficacy or loss of efficacy. When the reason was adverse effect the best option was switching to non anti TNF.
Keywords: Rheumatoid arthritis. Biological therapy. Survival. Anti-TNF. Non anti-TNF. Tocilizumab.
