Highlights of the International B-Cell Expert Forum
Highlights of the International B-Cell Expert Forum
Treatment with the selective inhibitor of B-cell expression — rituximab (Mabthera) — may be more effective in patients with persistent rheumatoid arthritis (RA) regardless of treatment with a tumor necrosis factor (TNF)-alpha inhibitor than switching to an alternative anti-TNF agent, according to a study reported at the recent B-Cell Expert Forum.
The open-label, "real-life" study included 100 RA patients from the Swiss national registry for RA (the Clinical Quality Management and National Registry for Patients with Rheumatoid Arthritis) who had all failed on a median of 2 anti-TNF agents. One third (n = 34) were treated with rituximab (2 infusions of 1000 mg given 2 weeks apart) plus methotrexate. The remainder (n = 66) were treated with a further anti-TNF agent and concomitant conventional disease-modifying antirheumatic drugs (DMARDs).
Results showed that the Disease Activity Scale (DAS) 28 fell by 1.45 (95%, confidence interval [CI], -1.05 to -1.85) in the rituximab group, compared with 1.14 (95% CI, -0.81 to -1.47) in patients treated with an anti-TNF agent at 6 months (P = .02). The reduction in erythrocyte sedimentation rate (ESR) was significantly greater with rituximab (P = .004). There was also a trend to greater reduction in tender and swollen joints, although this did not reach statistical significance.
"Although this is an observational study with a small number of patients, these results suggest that rituximab might be more effective than switching to an alternative anti-TNF agent in RA patients who have persistent active disease despite prior anti-TNF therapy," suggested Cem Gabay, MD, Associate Professor of Medicine, University Hospital of Geneva, Geneva, Switzerland, and lead investigator of the study.
A second daily practice study demonstrated that rituximab achieved significant improvement in disease activity in 18 patients with severe and active RA regardless of anti-TNF therapy or who had a contraindication to this group of agents (2 had class II heart failure and 2 had previously untreated tuberculosis). They were treated with rituximab (1000 mg administered intravenously on days 1 and 15) with corticosteroid treatment before each infusion and concomitant methotrexate (12.5-20 mg/week).
Results, updating preliminary data reported at this year's European League Against Rheumatism (EULAR) meeting, showed that 13 of the 18 patients achieved a EULAR response at 12 weeks, with 3 showing a good EULAR response. There was a trend to better response in patients with a contraindication to anti-TNF therapy:
DAS 28 fell from a mean of 6 at baseline to 5.3 at week 12 in patients who had shown an inadequate response to anti-TNF (P < .05) and to 2.9 in those with a contraindication (P < .05). In terms of side effects, 1 infusion-related reaction and 1 pulmonary infection occurred.
Lead investigator Yannick Allanore, MD, Associate Professor in Rheumatology, Cochin Hospital, Paris, France, said, "A single course of rituximab, in combination with methotrexate, provided significant improvement in disease activity at week 12, with good tolerance, in patients with severe and active rheumatoid arthritis despite anti-TNF agents and in those with a contraindication to these drugs." The patients are being followed up to determine the long-term effects.
Expert Forum Extends Understanding of Use of Rituximab in Clinical Practice
Treatment with the selective inhibitor of B-cell expression — rituximab (Mabthera) — may be more effective in patients with persistent rheumatoid arthritis (RA) regardless of treatment with a tumor necrosis factor (TNF)-alpha inhibitor than switching to an alternative anti-TNF agent, according to a study reported at the recent B-Cell Expert Forum.
The open-label, "real-life" study included 100 RA patients from the Swiss national registry for RA (the Clinical Quality Management and National Registry for Patients with Rheumatoid Arthritis) who had all failed on a median of 2 anti-TNF agents. One third (n = 34) were treated with rituximab (2 infusions of 1000 mg given 2 weeks apart) plus methotrexate. The remainder (n = 66) were treated with a further anti-TNF agent and concomitant conventional disease-modifying antirheumatic drugs (DMARDs).
Results showed that the Disease Activity Scale (DAS) 28 fell by 1.45 (95%, confidence interval [CI], -1.05 to -1.85) in the rituximab group, compared with 1.14 (95% CI, -0.81 to -1.47) in patients treated with an anti-TNF agent at 6 months (P = .02). The reduction in erythrocyte sedimentation rate (ESR) was significantly greater with rituximab (P = .004). There was also a trend to greater reduction in tender and swollen joints, although this did not reach statistical significance.
"Although this is an observational study with a small number of patients, these results suggest that rituximab might be more effective than switching to an alternative anti-TNF agent in RA patients who have persistent active disease despite prior anti-TNF therapy," suggested Cem Gabay, MD, Associate Professor of Medicine, University Hospital of Geneva, Geneva, Switzerland, and lead investigator of the study.
A second daily practice study demonstrated that rituximab achieved significant improvement in disease activity in 18 patients with severe and active RA regardless of anti-TNF therapy or who had a contraindication to this group of agents (2 had class II heart failure and 2 had previously untreated tuberculosis). They were treated with rituximab (1000 mg administered intravenously on days 1 and 15) with corticosteroid treatment before each infusion and concomitant methotrexate (12.5-20 mg/week).
Results, updating preliminary data reported at this year's European League Against Rheumatism (EULAR) meeting, showed that 13 of the 18 patients achieved a EULAR response at 12 weeks, with 3 showing a good EULAR response. There was a trend to better response in patients with a contraindication to anti-TNF therapy:
Eight of 9 showed a EULAR response compared with 5 of 9 patients who had shown inadequate response to an anti-TNF agent; and
Three of 9 of the contraindication group showed a good EULAR response compared with 0 of 9 of the inadequate response group.
DAS 28 fell from a mean of 6 at baseline to 5.3 at week 12 in patients who had shown an inadequate response to anti-TNF (P < .05) and to 2.9 in those with a contraindication (P < .05). In terms of side effects, 1 infusion-related reaction and 1 pulmonary infection occurred.
Lead investigator Yannick Allanore, MD, Associate Professor in Rheumatology, Cochin Hospital, Paris, France, said, "A single course of rituximab, in combination with methotrexate, provided significant improvement in disease activity at week 12, with good tolerance, in patients with severe and active rheumatoid arthritis despite anti-TNF agents and in those with a contraindication to these drugs." The patients are being followed up to determine the long-term effects.
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