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A Second Course of Rituximab Increases Clinical Efficacy in Rheumatoid Arthritis

AMSTERDAM — The clinical response to repeat courses of rituximab equalled or surpassed the initial course in patients with rheumatoid arthritis who are participating in a long-term open-label study, Dr. Paul Emery said at the annual European Congress of Rheumatology.

Patients with rheumatoid arthritis (RA) unresponsive to traditional disease-modifying antirheumatic drugs but who achieved at least a 20% improvement in tender and swollen joint counts following a single course of rituximab were eligible to receive additional courses for residual disease.

To date, 145 patients have received at least two courses, and 24-week follow-up data are available for 99. Each treatment course consists of two separate infusions, 1,000 mg each, 2 weeks apart.

Baseline characteristics of the 99 patients were similar to those of the original larger study population, where the mean age was 54 years and disease duration was 10 years.

Mean tender and swollen joint counts at baseline were approximately 32 and 20, respectively, and mean disease activity score including a 28-joint count (DAS28) was 6.8 (N. Engl. J. Med. 2004; 350:2572–81).

A total of 58 (59%) of patients had achieved an ACR20 response 24 weeks after the first course of rituximab, while 72 (73%) reached this level of response 24 weeks after the second course, according to Dr. Emery, professor of rheumatology and clinical director of the Academic Unit of Musculoskeletal Disease at the Leeds (England) Teaching Hospitals Trust.

Maximal efficacy with rituximab generally is seen at 24 weeks.

Increased efficacy also was apparent on other measures. (See table.)

Repeat courses of the B-cell-depleting agent were well tolerated, and there was no evidence of increased overall incidence of adverse events, numbers of infections, or infusion reactions, he said.

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AMSTERDAM — The clinical response to repeat courses of rituximab equalled or surpassed the initial course in patients with rheumatoid arthritis who are participating in a long-term open-label study, Dr. Paul Emery said at the annual European Congress of Rheumatology.

Patients with rheumatoid arthritis (RA) unresponsive to traditional disease-modifying antirheumatic drugs but who achieved at least a 20% improvement in tender and swollen joint counts following a single course of rituximab were eligible to receive additional courses for residual disease.

To date, 145 patients have received at least two courses, and 24-week follow-up data are available for 99. Each treatment course consists of two separate infusions, 1,000 mg each, 2 weeks apart.

Baseline characteristics of the 99 patients were similar to those of the original larger study population, where the mean age was 54 years and disease duration was 10 years.

Mean tender and swollen joint counts at baseline were approximately 32 and 20, respectively, and mean disease activity score including a 28-joint count (DAS28) was 6.8 (N. Engl. J. Med. 2004; 350:2572–81).

A total of 58 (59%) of patients had achieved an ACR20 response 24 weeks after the first course of rituximab, while 72 (73%) reached this level of response 24 weeks after the second course, according to Dr. Emery, professor of rheumatology and clinical director of the Academic Unit of Musculoskeletal Disease at the Leeds (England) Teaching Hospitals Trust.

Maximal efficacy with rituximab generally is seen at 24 weeks.

Increased efficacy also was apparent on other measures. (See table.)

Repeat courses of the B-cell-depleting agent were well tolerated, and there was no evidence of increased overall incidence of adverse events, numbers of infections, or infusion reactions, he said.

ELSEVIER GLOBAL MEDICAL NEWS

AMSTERDAM — The clinical response to repeat courses of rituximab equalled or surpassed the initial course in patients with rheumatoid arthritis who are participating in a long-term open-label study, Dr. Paul Emery said at the annual European Congress of Rheumatology.

Patients with rheumatoid arthritis (RA) unresponsive to traditional disease-modifying antirheumatic drugs but who achieved at least a 20% improvement in tender and swollen joint counts following a single course of rituximab were eligible to receive additional courses for residual disease.

To date, 145 patients have received at least two courses, and 24-week follow-up data are available for 99. Each treatment course consists of two separate infusions, 1,000 mg each, 2 weeks apart.

Baseline characteristics of the 99 patients were similar to those of the original larger study population, where the mean age was 54 years and disease duration was 10 years.

Mean tender and swollen joint counts at baseline were approximately 32 and 20, respectively, and mean disease activity score including a 28-joint count (DAS28) was 6.8 (N. Engl. J. Med. 2004; 350:2572–81).

A total of 58 (59%) of patients had achieved an ACR20 response 24 weeks after the first course of rituximab, while 72 (73%) reached this level of response 24 weeks after the second course, according to Dr. Emery, professor of rheumatology and clinical director of the Academic Unit of Musculoskeletal Disease at the Leeds (England) Teaching Hospitals Trust.

Maximal efficacy with rituximab generally is seen at 24 weeks.

Increased efficacy also was apparent on other measures. (See table.)

Repeat courses of the B-cell-depleting agent were well tolerated, and there was no evidence of increased overall incidence of adverse events, numbers of infections, or infusion reactions, he said.

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A Second Course of Rituximab Increases Clinical Efficacy in Rheumatoid Arthritis
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