Index Measures Partial Improvement in SLE

Major Finding: The SRI-50 tool signaled 50% improvement in 13 of the 24 SLEDAI-2K descriptors and in six of the nine assessed organ systems, findings that were undetected by the less-sensitive SLEDAI-2K.

Data Source: Results of SRI-50 in 100 patients.

Disclosures: Dr. Touma said he had no relevant financial conflicts to disclose.

MONTREAL — A proposed new tool that is sensitive enough to measure partial improvement in systemic lupus erythematosus could open the door to more precise monitoring of therapeutic response in both research and clinical practice, reported Dr. Zahi Touma at the annual meeting of the Canadian Rheumatology Association.

Currently, improvement in disease activity, or response to treatment, can be measured only as absent or present, using the SLEDAI-2K (Systemic Lupus Erythematosus Activity Index–2K), explained Dr. Touma, a clinical research fellow in rheumatology at the center for prognosis studies in the rheumatic diseases at the University of Toronto. However, this index is not designed to detect small but clinically meaningful improvements, he noted.

So his group developed a modified version, the SRI-50 (SLEDAI-2K Responder Index–50), which has been designed to capture at least a 50% response on the SLEDAI-2K. “We aimed to show a 50% improvement, because this was felt by clinicians to reflect a significant improvement,” he said in an interview.

The SRI-50 covers the same nine organ systems and uses the same 24 descriptors as does the SLEDAI-2K, said Dr. Touma. Scoring for each descriptor of SLEDAI-2K is halved to generate a new weighted score for each descriptor of the SRI-50.

For example, in a case of lupus nephritis that involves proteinuria at a level of serum protein in urine of 4 g/day, the SLEDAI-2K score would be 4.

At follow-up, a decrease in proteinuria to 2 g/day would generate the same SLEDAI-2K score of 4 (which is generated by any proteinuria above 0.5 g/day), but on the SRI-50, it would represent a 50% improvement and thus a score of 2.

To test the new measure, Dr. Touma's group performed a cross-sectional study of 100 patients who had experienced lupus flares or had persistently active disease.

The SLEDAI-2K was administered at the initial visit and then again after 1-3 months of treatment with prednisone and an immunosuppressant (hydroxychloroquine, azathioprine, methotrexate, or mycophenolate mofetil). The SRI-50 was also administered at the second visit.

Scores were calculated using a data retrieval form, with a range of scores from 1 (best) to 10 (worst) for each of the 24 descriptors. “It's very important to have a data retrieval form because if you are dealing with rash or arthritis you need a very accurate, standardized method of documentation,” he said.

For 72 patients, the SLEDAI-2K provided a satisfactory assessment at the second visit because their disease had either resolved completely or remained unchanged. However, for the remaining 28 patients, the SRI-50 signaled partial improvement that was undetected by the less-sensitive SLEDAI-2K. Among these patients, a 50% improvement was detected in 13 of the 24 descriptors and in six of the nine organ systems, said Dr. Touma.

Among these 28 patients, 90% were female, 53% were white, 16% were black, 10% were Chinese, and 21% were “other.” Their mean age at diagnosis was 32 years, and their mean duration of disease at first study visit was 13 years. Varying levels of disease activity were recorded at the first visit.

Three subjects had a SLEDAI-2K score of 2; three had a score of 4; six had a score of 6; six had a score of 8; three had a score of 10; two had a score of 12; one had a score of 16; one had a score of 18; two had a score of 20; and one had a score of 21.

Dr. Touma said the goal of the study was primarily to develop a more sensitive tool to measure outcomes in clinical trials. However, he believes the SRI-50 will also play an important role in clinical practice, where “it is always crucial to be able to show that a patient is responding to medical treatment.”

Major Finding: The SRI-50 tool signaled 50% improvement in 13 of the 24 SLEDAI-2K descriptors and in six of the nine assessed organ systems, findings that were undetected by the less-sensitive SLEDAI-2K.

Data Source: Results of SRI-50 in 100 patients.

Disclosures: Dr. Touma said he had no relevant financial conflicts to disclose.

MONTREAL — A proposed new tool that is sensitive enough to measure partial improvement in systemic lupus erythematosus could open the door to more precise monitoring of therapeutic response in both research and clinical practice, reported Dr. Zahi Touma at the annual meeting of the Canadian Rheumatology Association.

Currently, improvement in disease activity, or response to treatment, can be measured only as absent or present, using the SLEDAI-2K (Systemic Lupus Erythematosus Activity Index–2K), explained Dr. Touma, a clinical research fellow in rheumatology at the center for prognosis studies in the rheumatic diseases at the University of Toronto. However, this index is not designed to detect small but clinically meaningful improvements, he noted.

So his group developed a modified version, the SRI-50 (SLEDAI-2K Responder Index–50), which has been designed to capture at least a 50% response on the SLEDAI-2K. “We aimed to show a 50% improvement, because this was felt by clinicians to reflect a significant improvement,” he said in an interview.

The SRI-50 covers the same nine organ systems and uses the same 24 descriptors as does the SLEDAI-2K, said Dr. Touma. Scoring for each descriptor of SLEDAI-2K is halved to generate a new weighted score for each descriptor of the SRI-50.

For example, in a case of lupus nephritis that involves proteinuria at a level of serum protein in urine of 4 g/day, the SLEDAI-2K score would be 4.

At follow-up, a decrease in proteinuria to 2 g/day would generate the same SLEDAI-2K score of 4 (which is generated by any proteinuria above 0.5 g/day), but on the SRI-50, it would represent a 50% improvement and thus a score of 2.

To test the new measure, Dr. Touma's group performed a cross-sectional study of 100 patients who had experienced lupus flares or had persistently active disease.

The SLEDAI-2K was administered at the initial visit and then again after 1-3 months of treatment with prednisone and an immunosuppressant (hydroxychloroquine, azathioprine, methotrexate, or mycophenolate mofetil). The SRI-50 was also administered at the second visit.

Scores were calculated using a data retrieval form, with a range of scores from 1 (best) to 10 (worst) for each of the 24 descriptors. “It's very important to have a data retrieval form because if you are dealing with rash or arthritis you need a very accurate, standardized method of documentation,” he said.

For 72 patients, the SLEDAI-2K provided a satisfactory assessment at the second visit because their disease had either resolved completely or remained unchanged. However, for the remaining 28 patients, the SRI-50 signaled partial improvement that was undetected by the less-sensitive SLEDAI-2K. Among these patients, a 50% improvement was detected in 13 of the 24 descriptors and in six of the nine organ systems, said Dr. Touma.

Among these 28 patients, 90% were female, 53% were white, 16% were black, 10% were Chinese, and 21% were “other.” Their mean age at diagnosis was 32 years, and their mean duration of disease at first study visit was 13 years. Varying levels of disease activity were recorded at the first visit.

Three subjects had a SLEDAI-2K score of 2; three had a score of 4; six had a score of 6; six had a score of 8; three had a score of 10; two had a score of 12; one had a score of 16; one had a score of 18; two had a score of 20; and one had a score of 21.

Dr. Touma said the goal of the study was primarily to develop a more sensitive tool to measure outcomes in clinical trials. However, he believes the SRI-50 will also play an important role in clinical practice, where “it is always crucial to be able to show that a patient is responding to medical treatment.”

Major Finding: The SRI-50 tool signaled 50% improvement in 13 of the 24 SLEDAI-2K descriptors and in six of the nine assessed organ systems, findings that were undetected by the less-sensitive SLEDAI-2K.

Data Source: Results of SRI-50 in 100 patients.

Disclosures: Dr. Touma said he had no relevant financial conflicts to disclose.

MONTREAL — A proposed new tool that is sensitive enough to measure partial improvement in systemic lupus erythematosus could open the door to more precise monitoring of therapeutic response in both research and clinical practice, reported Dr. Zahi Touma at the annual meeting of the Canadian Rheumatology Association.

Currently, improvement in disease activity, or response to treatment, can be measured only as absent or present, using the SLEDAI-2K (Systemic Lupus Erythematosus Activity Index–2K), explained Dr. Touma, a clinical research fellow in rheumatology at the center for prognosis studies in the rheumatic diseases at the University of Toronto. However, this index is not designed to detect small but clinically meaningful improvements, he noted.

So his group developed a modified version, the SRI-50 (SLEDAI-2K Responder Index–50), which has been designed to capture at least a 50% response on the SLEDAI-2K. “We aimed to show a 50% improvement, because this was felt by clinicians to reflect a significant improvement,” he said in an interview.

The SRI-50 covers the same nine organ systems and uses the same 24 descriptors as does the SLEDAI-2K, said Dr. Touma. Scoring for each descriptor of SLEDAI-2K is halved to generate a new weighted score for each descriptor of the SRI-50.

For example, in a case of lupus nephritis that involves proteinuria at a level of serum protein in urine of 4 g/day, the SLEDAI-2K score would be 4.

At follow-up, a decrease in proteinuria to 2 g/day would generate the same SLEDAI-2K score of 4 (which is generated by any proteinuria above 0.5 g/day), but on the SRI-50, it would represent a 50% improvement and thus a score of 2.

To test the new measure, Dr. Touma's group performed a cross-sectional study of 100 patients who had experienced lupus flares or had persistently active disease.

The SLEDAI-2K was administered at the initial visit and then again after 1-3 months of treatment with prednisone and an immunosuppressant (hydroxychloroquine, azathioprine, methotrexate, or mycophenolate mofetil). The SRI-50 was also administered at the second visit.

Scores were calculated using a data retrieval form, with a range of scores from 1 (best) to 10 (worst) for each of the 24 descriptors. “It's very important to have a data retrieval form because if you are dealing with rash or arthritis you need a very accurate, standardized method of documentation,” he said.

For 72 patients, the SLEDAI-2K provided a satisfactory assessment at the second visit because their disease had either resolved completely or remained unchanged. However, for the remaining 28 patients, the SRI-50 signaled partial improvement that was undetected by the less-sensitive SLEDAI-2K. Among these patients, a 50% improvement was detected in 13 of the 24 descriptors and in six of the nine organ systems, said Dr. Touma.

Among these 28 patients, 90% were female, 53% were white, 16% were black, 10% were Chinese, and 21% were “other.” Their mean age at diagnosis was 32 years, and their mean duration of disease at first study visit was 13 years. Varying levels of disease activity were recorded at the first visit.

Three subjects had a SLEDAI-2K score of 2; three had a score of 4; six had a score of 6; six had a score of 8; three had a score of 10; two had a score of 12; one had a score of 16; one had a score of 18; two had a score of 20; and one had a score of 21.

Dr. Touma said the goal of the study was primarily to develop a more sensitive tool to measure outcomes in clinical trials. However, he believes the SRI-50 will also play an important role in clinical practice, where “it is always crucial to be able to show that a patient is responding to medical treatment.”