AB0275 TOFACITINIB EFFECTIVENESS IN PATIENTS WITH RHEUMATOID ARTHRITIS AFTER CONVENTIONAL OR BIOLOGICAL THERAPY - IT REAL ROLE IN DIFFERENT LINES OF TREATMENT
Authors: W. Rivero, L. Ibata, S. Martinez, A. Rojas-Villarraga, P. Santos-Moreno
Journal: Annals of the Rheumatic Diseases (2021)

Background: rheumatoid arthritis (RA) is a chronic and disabling autoimmune disease, with a high clinical and economic burden. This implies the need to investigate therapies that maximize clinical results. Tofacitinib is recommended as a different alternative to biologic therapy when a patient remains with moderate or high disease activity after conventional DMARDs use, or as an option after failure to biologic therapy. Objectives: to evaluate the effectiveness of Tofacitinib in RA as first-line (after conventional DMARDs failure) or second-line treatment (after biologic therapy failure) in a real-life cohort of RA patients and its differences. Methods: this is a descriptive retrospective cohort study conducted at a specialized center for RA in Bogota, Colombia; databases from 2017 to 2019 were used to select and study patients with indication of Tofacitinib, regardless of their previous treatment or disease status. The indication and initiation of Tofacitinib (5 mg BID or 11 mg once daily) was an independent medical decision made as part of the individualized management of every patient. Effectiveness was evaluated in those patients who met the high adherence criteria (at least three visits with a rheumatologist per year), with no change or addition of other conventional DMARDs. Frequencies and proportions in baseline characteristics, differences in disease activity were calculated between the first and second line tofacitinib treatment. Comparisons of continuous variables data between the two patient groups were made using the t-test; the chi-square test and Fisher’s exact test were used for statistical analysis of categorical variables. Logistic regressions were performed to analyze related factors with therapeutic response outcomes. Results: we included 152 RA patients who received tofacitinib: first-line (T1) (n= 85, 55.9%) or second-line (T2) (n= 67, 44.1%). T1 first-line group was younger than the T2 second-line patients (53±12.8 years and 59±11.4 years, p-value 0.01) and they had a shorter disease duration than T2 patients (11.8 vs. 12.8 years, p-value 0.01). Comparative analysis of response to treatment showed a reduction in DAS28 at 3, 6 and 12 months in both study groups. The response in disease activity at 3 months was a major factor related to 6-month response (OR 13.4, 95% CI 4.5-39.4, p value 0.000), while non-response at 3 months were associated with no response at 6 months of follow-up. Baseline DAS28 was significantly associated with response at 12 months (OR 1.9, 95% CI 1.11-3.25, p-value 0.028). At 12 months of treatment, both groups showed disease response and control according to the DAS28 from baseline, but a higher proportion of T1 patients achieved remission (45% vs 23%). A subgroup analysis to evaluate T2 second-line Tofacitinib therapy showed no statistically significant differences in any response criteria according to the number of previously received biologicals. Table 1. Regression analysis (risk of response of the disease at 6 and 12 months of treatment with Tofacitinib) Factor Response at Month 6 Response at Month 12* OR IC95% P value OR IC95% P value Age 1.00 0.97-1.03 0.788 1.02 0.98-1.06 0.211 Male 1.82 0.65-5.08 0.251 0.81 0.27-2.38 0.709 Duration of RA 0.99 0.94-1.04 0.908 1.02 0.96-1.08 0.444 Positive Rheumatoid Factor 0.81 026-2.56 0.730 0.63 0.17-2.26 0.485 Positive Anti-CCP 0.34 0.068-1.6 0.189 Initial DAS28 1.61 1.04-2.49 0.033 1.9 1.11-3.25 0.018 First line 0.44 0.19-1.01 0.054 1.47 0.56-3.83 0.423 Treatment period 1.12 0.80-1.55 0.492 1.1 0.75-1.61 0.607 Dose: 11 mg. 0.95 0.42-2.13 0.904 0.75 0.258-1.9 0.565 Response at Month 3 13.42 4.57-39.4 0.000 2.32 0.87-6.18 0.091 *Positive Anti-CCP at month 12 was omitted because of collinearity Conclusion: Tofacitinib is an effective treatment option for patients with RA after conventional DMARDs and in patients after biologic therapy failure, but maybe is better used it as a T1 first-line of treatment. Further studies are required to determine the real role of tofacitinib in different lines of RA treatment. Disclosure of Interests: Wilberto Rivero: None declared, Linda Ibata: None declared, Susan Martinez: None declared, Adriana Rojas-Villarraga: None declared, Pedro Santos-Moreno Speakers bureau: Pedro Santos-Moreno has received fees for conferences from: Abbvie, Biopas-UCB, Bristol, Janssen, Pfizer, Sanofi., Consultant of: Pedro Santos-Moreno has received fees for counseling and advisory boards from: Abbvie, Abbott, Biopas-UCB, Bristol, Janssen, Pfizer, Roche, Sanofi., Grant/research support from: Pedro Santos-Moreno has received research grants from: Abbvie, Abbott, Biopas-UCB, Bristol, Janssen, Pfizer, Roche, Sanofi.