AB0416B EFFICACY OF INFLIXIMAB IN RA PATIENTS BASED ON TOTAL COUNT OF INFUSIONS
Authors: Eugenia Aronova, Galina Lukina
Journal: Annals of the Rheumatic Diseases (2019)

<h3>Objectives</h3> To analyze the correlation between cumulative dose of infused infliximab and its' therapeutic and antidestructive effect in patients with rheumatoid arthritis (RA). <h3>Methods</h3> 135 patients with confirmed RA were included into a 1-year study. All patients were assigned to a recommended dosing regimen of 3 mg/kg infliximab as an intravenous induction at 0, 2 and 6 weeks followed by a maintenance 3 mg/kg dose every 8 weeks thereafter. Clinical (TJC and SJC), laboratory (CRP and ESR) parameters and quality of life assessments (HAQ) were performed during each visit. The score trends of DAS28 disease activity scale were used as the primary criterion for evaluation of infliximab therapeutic effect. Sharp Vander Heijde (SvH) modification scoring method was used for dynamic assessment of erosion and for joint space narrowing. All patients were assessed and examined according to the Protocol before each infusion of infliximab. Therapeutic results were evaluated in all ITT population at Week 54 from the initiation of treatment (including those who did not complete the envisaged course of infliximab). The patients were divided into three groups: those who received ≤ 4 infusions of infliximab (N=63); those who received 5–7 infusions of infliximab (N=31); those who received ≥ 8 infusions of infliximab (N=41). Patients from Group 1 received at average 2.5 infusion of infliximab, from Group 2 - 5.8 infusion, and from Group 3 – 8,8 infusion. <h3>Results</h3> High disease activity based on DAS 28 (&gt;5,1) score was documented in the majority of participants at baseline: in 69% - in Group 1, in 86,6% - in Group 2, and in 62.1% - in Group 3. Moderate RA activity (3.2 &lt; DAS 28 ≤ 5,1) was found in 31% in Group 1, in 13.4% - in Group 2, and in 37.9% - in Group 3. All patients demonstrated rapid (already by Week 14 on-treatment) and significant (p&lt;0.05) decrease of RA activity. This reduction remained significant by the end of the study at Week 54 as compared to baseline scores. Meanwhile, by the end of the study the mean DAS 28 score in Group 1 was significantly higher compared to Groups 2 and 3. No significant differences were found between Groups 2 and 3 during the FUP. Similar patterns in RA activity differentiation were identified within individual groups: the highest proportion of pts with high laboratory activity at Week 54 was found in Group 1, receiving ≤ 4 infliximab infusions. The Group 3 showed the highest proportion of patients with low laboratory RA activity at Week 54 (including patients in remission according to DAS 28 criteria) (53.9% compared to 27.3% and 50% in Groups 1 and 2, respectively). Percentages of remissions in Groups 3 and 2 were comparable (28.6% and 23.1%, respectively), while in Group 1 the remission rates were lower (18.2%). We analyzed the dynamics of total Sharpe score during 54 weeks FUP in all three groups, and found that patients receiving ≤ 4 infliximab infusions demonstrated more significant radiological progression as compared to patients from two other groups. <h3>Conclusion</h3> Low cumulative dose of infliximab can induce a long-lasting clinical effect, but does not significantly inhibit further destruction of joints. There were no significant differences between Groups 2 and 3 in the degree of radiological progression. <h3>Disclosure of Interests</h3> None declared