Rituximab in Patients With Rheumatoid Arthritis
Objective The objective of this study was to evaluate the long-term safety and efficacy of repeated rituximab (RTX) infusions in the treatment of rheumatoid arthritis in daily clinical practice in Finland.
Methods Data were collected from the medical records of a total of 151 patients with rheumatoid arthritis treated with RTX and followed up for at least 12 months after the treatment onset. Change in the 28-joint Disease Activity Score (DAS28), European League Against Rheumatism response criteria and proportions of patients reaching disease remission (DAS28 < 2.6) or low disease activity (DAS28 < 3.2) were used to assess the clinical response.
Results Of the 151 patients 128 received 2 courses, 76 received 3 courses, and 42 received 4 courses of RTX. The mean time to retreatment for the first 4 courses varied between 11 and 13 months. Median DAS28 decreased from 5.4 (0.5–8.6) to 3.3 (0.6–6.6) after the first course. After the second treatment course, the DAS28 was 3.1 (range, 0.1–6.5). The median precourse baseline DAS28 before the second and third courses were 4.6 (range, 1.7–7.8) and 4.24 (range, 1.7–7.2), respectively. The number of previously failed tumor necrosis factor inhibitors did not predict response to RTX in this patient cohort with extensive use of previous disease-modifying antirheumatic drugs (median = 6).
Conclusions The treatment as-needed regimen used in this study cohort led to delayed RTX retreatment and disease flare in a significant proportion of patients. A regular retreatment every 6 months, at least, after the first 2 treatment courses in patients who are not in remission could allow better control of disease activity.
Rituximab (RTX) in combination with methotrexate (MTX) is approved in Finland for the treatment of severe active rheumatoid arthritis (RA) in patients who have not responded to conventional disease-modifying antirheumatic drugs (DMARDs) and to at least 1 anti–tumor necrosis factor α (anti–TNF-α) therapy or are intolerant to anti–TNF-α's. The need for treatment beyond TNF-α inhibitors is evident because 25% of patients treated with TNF-α inhibitors either do not achieve adequate clinical response or are unable to tolerate them during the first year, and the 5-year cumulative drug survival for TNF-α inhibitors is approximately 50%.
Rituximab has a unique mode of action and long dosing interval. The standard course of RTX is two 1000-mg intravenous infusions with interval of 2 weeks between each dose. The optimal treatment paradigm for RTX has not been definitely determined. However, there is increasing evidence that retreatment after 24 weeks in RA patients with residual disease activity leads to improved efficacy and tighter control of disease activity compared with retreating patients after they have experienced an obvious disease flare. The aim of the present study was to evaluate the long-term safety and efficacy of repeated RTX treatments in daily clinical practice.
Abstract and Introduction
Abstract
Objective The objective of this study was to evaluate the long-term safety and efficacy of repeated rituximab (RTX) infusions in the treatment of rheumatoid arthritis in daily clinical practice in Finland.
Methods Data were collected from the medical records of a total of 151 patients with rheumatoid arthritis treated with RTX and followed up for at least 12 months after the treatment onset. Change in the 28-joint Disease Activity Score (DAS28), European League Against Rheumatism response criteria and proportions of patients reaching disease remission (DAS28 < 2.6) or low disease activity (DAS28 < 3.2) were used to assess the clinical response.
Results Of the 151 patients 128 received 2 courses, 76 received 3 courses, and 42 received 4 courses of RTX. The mean time to retreatment for the first 4 courses varied between 11 and 13 months. Median DAS28 decreased from 5.4 (0.5–8.6) to 3.3 (0.6–6.6) after the first course. After the second treatment course, the DAS28 was 3.1 (range, 0.1–6.5). The median precourse baseline DAS28 before the second and third courses were 4.6 (range, 1.7–7.8) and 4.24 (range, 1.7–7.2), respectively. The number of previously failed tumor necrosis factor inhibitors did not predict response to RTX in this patient cohort with extensive use of previous disease-modifying antirheumatic drugs (median = 6).
Conclusions The treatment as-needed regimen used in this study cohort led to delayed RTX retreatment and disease flare in a significant proportion of patients. A regular retreatment every 6 months, at least, after the first 2 treatment courses in patients who are not in remission could allow better control of disease activity.
Introduction
Rituximab (RTX) in combination with methotrexate (MTX) is approved in Finland for the treatment of severe active rheumatoid arthritis (RA) in patients who have not responded to conventional disease-modifying antirheumatic drugs (DMARDs) and to at least 1 anti–tumor necrosis factor α (anti–TNF-α) therapy or are intolerant to anti–TNF-α's. The need for treatment beyond TNF-α inhibitors is evident because 25% of patients treated with TNF-α inhibitors either do not achieve adequate clinical response or are unable to tolerate them during the first year, and the 5-year cumulative drug survival for TNF-α inhibitors is approximately 50%.
Rituximab has a unique mode of action and long dosing interval. The standard course of RTX is two 1000-mg intravenous infusions with interval of 2 weeks between each dose. The optimal treatment paradigm for RTX has not been definitely determined. However, there is increasing evidence that retreatment after 24 weeks in RA patients with residual disease activity leads to improved efficacy and tighter control of disease activity compared with retreating patients after they have experienced an obvious disease flare. The aim of the present study was to evaluate the long-term safety and efficacy of repeated RTX treatments in daily clinical practice.