Lower residual RA activity after initial ETN-MTX, better remission chance

There are four factors at baseline in adults with moderately active rheumatoid arthritis that predict those who are most likely to achieve remission with full-dose combo etanercept-methotrexate (ETN-MTX) induction treatment, said Josef S. Smolen, MD, of the University of Vienna, and his associates.

The original PRESERVE study found that after 604 adults with moderately active rheumatoid arthritis achieved low disease activity after 36 weeks of full-dose etanercept (50 mg once weekly) plus methotrexate, subsequent full-dose or reduced-dose (25 mg once weekly) ETN-MTX combos were better at maintaining remission than was methotrexate alone. At the time of the original study, a Disease Activity Score in 28 joints (DAS28) less than 2.6 was considered to denote remission in practice and clinical trials; now that the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definition of remission has been published, a DAS28 less than 2.6 no longer indicates remission according to ACR/EULAR criteria, but rather indicates minimal disease activity, the investigators explained.

This study aimed to determine predictors of remission, the researchers said in their article published in Arthritis Research & Therapy.

Those predictors at baseline are young age; body mass index less than 30 kg/m^2; lower Health Assessment Questionnaire scores; and lower disease activity – as measured by DAS28, Simplified Disease Activity Index, and Clinical Disease Activity Index.

If the predictors are favorable and the patients have an “early, strong, and durable response to induction therapy, they are most likely to experience a sustained response after biologic tapering or withdrawal,” Dr. Smolen and his associates said.

In other words, the investigators found that, the lower the residual disease activity, the greater the chance of an enduring response.

“Our findings suggest that patients who did not achieve sustained remission in the open-label period and had higher DAS28 at week 36 were more likely to lose remission with maintenance therapy in the double-blind period. Not surprisingly, patients who achieved remission at only week 36, those who sustained remission at only weeks 28 and 36, and those who sustained remission at only weeks 20, 28, and 36, were at higher risk for loss of remission than patients who sustained remission from week 12 to week 36, indicating that depth of disease control is an important predictor of remission loss,” noted Dr. Smolen and his colleagues.

This study was sponsored by Pfizer. Dr. Smolen has received research grants and consulting fees from AbbVie, Pfizer, Roche, and other biopharmaceutical companies. Several of the investigators are employees of Pfizer and hold Pfizer stock. Another author is an employee of inVentiv Health and was contracted by Pfizer to provide statistical support.

SOURCE: Smolen JS et al. Arthritis Res Ther. doi: 10.1186/s13075-017-1484-9.

There are four factors at baseline in adults with moderately active rheumatoid arthritis that predict those who are most likely to achieve remission with full-dose combo etanercept-methotrexate (ETN-MTX) induction treatment, said Josef S. Smolen, MD, of the University of Vienna, and his associates.

The original PRESERVE study found that after 604 adults with moderately active rheumatoid arthritis achieved low disease activity after 36 weeks of full-dose etanercept (50 mg once weekly) plus methotrexate, subsequent full-dose or reduced-dose (25 mg once weekly) ETN-MTX combos were better at maintaining remission than was methotrexate alone. At the time of the original study, a Disease Activity Score in 28 joints (DAS28) less than 2.6 was considered to denote remission in practice and clinical trials; now that the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definition of remission has been published, a DAS28 less than 2.6 no longer indicates remission according to ACR/EULAR criteria, but rather indicates minimal disease activity, the investigators explained.

This study aimed to determine predictors of remission, the researchers said in their article published in Arthritis Research & Therapy.

Those predictors at baseline are young age; body mass index less than 30 kg/m^2; lower Health Assessment Questionnaire scores; and lower disease activity – as measured by DAS28, Simplified Disease Activity Index, and Clinical Disease Activity Index.

If the predictors are favorable and the patients have an “early, strong, and durable response to induction therapy, they are most likely to experience a sustained response after biologic tapering or withdrawal,” Dr. Smolen and his associates said.

In other words, the investigators found that, the lower the residual disease activity, the greater the chance of an enduring response.

“Our findings suggest that patients who did not achieve sustained remission in the open-label period and had higher DAS28 at week 36 were more likely to lose remission with maintenance therapy in the double-blind period. Not surprisingly, patients who achieved remission at only week 36, those who sustained remission at only weeks 28 and 36, and those who sustained remission at only weeks 20, 28, and 36, were at higher risk for loss of remission than patients who sustained remission from week 12 to week 36, indicating that depth of disease control is an important predictor of remission loss,” noted Dr. Smolen and his colleagues.

This study was sponsored by Pfizer. Dr. Smolen has received research grants and consulting fees from AbbVie, Pfizer, Roche, and other biopharmaceutical companies. Several of the investigators are employees of Pfizer and hold Pfizer stock. Another author is an employee of inVentiv Health and was contracted by Pfizer to provide statistical support.

SOURCE: Smolen JS et al. Arthritis Res Ther. doi: 10.1186/s13075-017-1484-9.

There are four factors at baseline in adults with moderately active rheumatoid arthritis that predict those who are most likely to achieve remission with full-dose combo etanercept-methotrexate (ETN-MTX) induction treatment, said Josef S. Smolen, MD, of the University of Vienna, and his associates.

The original PRESERVE study found that after 604 adults with moderately active rheumatoid arthritis achieved low disease activity after 36 weeks of full-dose etanercept (50 mg once weekly) plus methotrexate, subsequent full-dose or reduced-dose (25 mg once weekly) ETN-MTX combos were better at maintaining remission than was methotrexate alone. At the time of the original study, a Disease Activity Score in 28 joints (DAS28) less than 2.6 was considered to denote remission in practice and clinical trials; now that the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Boolean definition of remission has been published, a DAS28 less than 2.6 no longer indicates remission according to ACR/EULAR criteria, but rather indicates minimal disease activity, the investigators explained.

This study aimed to determine predictors of remission, the researchers said in their article published in Arthritis Research & Therapy.

Those predictors at baseline are young age; body mass index less than 30 kg/m^2; lower Health Assessment Questionnaire scores; and lower disease activity – as measured by DAS28, Simplified Disease Activity Index, and Clinical Disease Activity Index.

If the predictors are favorable and the patients have an “early, strong, and durable response to induction therapy, they are most likely to experience a sustained response after biologic tapering or withdrawal,” Dr. Smolen and his associates said.

In other words, the investigators found that, the lower the residual disease activity, the greater the chance of an enduring response.

“Our findings suggest that patients who did not achieve sustained remission in the open-label period and had higher DAS28 at week 36 were more likely to lose remission with maintenance therapy in the double-blind period. Not surprisingly, patients who achieved remission at only week 36, those who sustained remission at only weeks 28 and 36, and those who sustained remission at only weeks 20, 28, and 36, were at higher risk for loss of remission than patients who sustained remission from week 12 to week 36, indicating that depth of disease control is an important predictor of remission loss,” noted Dr. Smolen and his colleagues.

This study was sponsored by Pfizer. Dr. Smolen has received research grants and consulting fees from AbbVie, Pfizer, Roche, and other biopharmaceutical companies. Several of the investigators are employees of Pfizer and hold Pfizer stock. Another author is an employee of inVentiv Health and was contracted by Pfizer to provide statistical support.

SOURCE: Smolen JS et al. Arthritis Res Ther. doi: 10.1186/s13075-017-1484-9.