TNF tapering can be successful for patients with RA

ROME – Many patients with rheumatoid arthritis can reduce – or even discontinue – their

maintenance therapy with tumor necrosis factor inhibitors after they achieve clinical stability.

Half who reduced their medication did not have a disease flare over 12 months, Dr. James Galloway reported at the annual meeting of the European League Against Rheumatism. And those who did flare quickly became stable again after their medications were restarted.

The implications are not only clinical, but economic, said Dr. Galloway of Kings College, London.

“First of all, why would we want our patients to take more medicine than they need to control symptoms?” he said in an interview. “And cost is another consideration. Maintenance with tumor necrosis factor inhibitors is expensive. By tapering the dose we can try to achieve a balance between symptoms control and cost.”

Dr. Galloway reported results of the OPTTIRA study a 12-month randomized trial that investigated whether tapering TNF inhibitors would cause patients to lose their response.

The trial recruited 103 patients who were taking etanercept or adalimumab plus a disease-modifying antirheumatic drug. Patients had to be stable with a Disease Activity Score (DAS28) of less than 3.2 for at least 3 months. They were excluded if they had serious concomitant illness or were taking high-dose steroids.

For the first 6 months, there were three treatment arms: controls, who received constant TNF inhibition; a 33% taper group; and a 66% taper group. If patients who tapered experienced a flare (a DAS28 increase of at least 0.6 plus one or more swollen joints), their baseline dosage was restarted.

From 6-12 months, both the tapering groups stopped their TNF inhibitors altogether, and the control group tapered in the two schedules. Outcomes were flare rates and DAS28 scores after 6 months of constant or tapered TNF inhibition.

Flares occurred in 14% of the control group and 13% of the 1/3 tapering group. Both of these rates were significantly less than the 37% flare rate in the 2/3 dose tapering group. Decreasing TNF inhibition by 66% quadrupled the risk of a flare compared to the other treatment arms (OR 4.1).

However, Dr. Galloway said, all of the flares subsided quickly when patients resumed their baseline dose.

Of the patients who tapered and then stopped TNF inhibitors altogether, 45% had not flared by the end of the study; their final DAS28 score was 2.2. There were no adverse events related to medication tapering. At the end of the study, there were no significant differences in the Health Assessment Questionnaire with either tapering strategy.

Although describing the outcome as positive, Dr. Galloway admitted that TNF tapering could be a tough sell to patients who have struggled to get control of their disease and abhor the thought of losing it.

“In fact,” he said, “about 40% of those we initially screened declined to go through with the study because they feared a relapse,” he said. “But I think many patients would consider this if we explain both the potential clinical and economic benefits, and reassure them that if they do flare, they can regain control rapidly on the same regimen that has been working for them.”

Dr. Galloway had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @Alz_Gal

ROME – Many patients with rheumatoid arthritis can reduce – or even discontinue – their

maintenance therapy with tumor necrosis factor inhibitors after they achieve clinical stability.

Half who reduced their medication did not have a disease flare over 12 months, Dr. James Galloway reported at the annual meeting of the European League Against Rheumatism. And those who did flare quickly became stable again after their medications were restarted.

The implications are not only clinical, but economic, said Dr. Galloway of Kings College, London.

“First of all, why would we want our patients to take more medicine than they need to control symptoms?” he said in an interview. “And cost is another consideration. Maintenance with tumor necrosis factor inhibitors is expensive. By tapering the dose we can try to achieve a balance between symptoms control and cost.”

Dr. Galloway reported results of the OPTTIRA study a 12-month randomized trial that investigated whether tapering TNF inhibitors would cause patients to lose their response.

The trial recruited 103 patients who were taking etanercept or adalimumab plus a disease-modifying antirheumatic drug. Patients had to be stable with a Disease Activity Score (DAS28) of less than 3.2 for at least 3 months. They were excluded if they had serious concomitant illness or were taking high-dose steroids.

For the first 6 months, there were three treatment arms: controls, who received constant TNF inhibition; a 33% taper group; and a 66% taper group. If patients who tapered experienced a flare (a DAS28 increase of at least 0.6 plus one or more swollen joints), their baseline dosage was restarted.

From 6-12 months, both the tapering groups stopped their TNF inhibitors altogether, and the control group tapered in the two schedules. Outcomes were flare rates and DAS28 scores after 6 months of constant or tapered TNF inhibition.

Flares occurred in 14% of the control group and 13% of the 1/3 tapering group. Both of these rates were significantly less than the 37% flare rate in the 2/3 dose tapering group. Decreasing TNF inhibition by 66% quadrupled the risk of a flare compared to the other treatment arms (OR 4.1).

However, Dr. Galloway said, all of the flares subsided quickly when patients resumed their baseline dose.

Of the patients who tapered and then stopped TNF inhibitors altogether, 45% had not flared by the end of the study; their final DAS28 score was 2.2. There were no adverse events related to medication tapering. At the end of the study, there were no significant differences in the Health Assessment Questionnaire with either tapering strategy.

Although describing the outcome as positive, Dr. Galloway admitted that TNF tapering could be a tough sell to patients who have struggled to get control of their disease and abhor the thought of losing it.

“In fact,” he said, “about 40% of those we initially screened declined to go through with the study because they feared a relapse,” he said. “But I think many patients would consider this if we explain both the potential clinical and economic benefits, and reassure them that if they do flare, they can regain control rapidly on the same regimen that has been working for them.”

Dr. Galloway had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @Alz_Gal

ROME – Many patients with rheumatoid arthritis can reduce – or even discontinue – their

maintenance therapy with tumor necrosis factor inhibitors after they achieve clinical stability.

Half who reduced their medication did not have a disease flare over 12 months, Dr. James Galloway reported at the annual meeting of the European League Against Rheumatism. And those who did flare quickly became stable again after their medications were restarted.

The implications are not only clinical, but economic, said Dr. Galloway of Kings College, London.

“First of all, why would we want our patients to take more medicine than they need to control symptoms?” he said in an interview. “And cost is another consideration. Maintenance with tumor necrosis factor inhibitors is expensive. By tapering the dose we can try to achieve a balance between symptoms control and cost.”

Dr. Galloway reported results of the OPTTIRA study a 12-month randomized trial that investigated whether tapering TNF inhibitors would cause patients to lose their response.

The trial recruited 103 patients who were taking etanercept or adalimumab plus a disease-modifying antirheumatic drug. Patients had to be stable with a Disease Activity Score (DAS28) of less than 3.2 for at least 3 months. They were excluded if they had serious concomitant illness or were taking high-dose steroids.

For the first 6 months, there were three treatment arms: controls, who received constant TNF inhibition; a 33% taper group; and a 66% taper group. If patients who tapered experienced a flare (a DAS28 increase of at least 0.6 plus one or more swollen joints), their baseline dosage was restarted.

From 6-12 months, both the tapering groups stopped their TNF inhibitors altogether, and the control group tapered in the two schedules. Outcomes were flare rates and DAS28 scores after 6 months of constant or tapered TNF inhibition.

Flares occurred in 14% of the control group and 13% of the 1/3 tapering group. Both of these rates were significantly less than the 37% flare rate in the 2/3 dose tapering group. Decreasing TNF inhibition by 66% quadrupled the risk of a flare compared to the other treatment arms (OR 4.1).

However, Dr. Galloway said, all of the flares subsided quickly when patients resumed their baseline dose.

Of the patients who tapered and then stopped TNF inhibitors altogether, 45% had not flared by the end of the study; their final DAS28 score was 2.2. There were no adverse events related to medication tapering. At the end of the study, there were no significant differences in the Health Assessment Questionnaire with either tapering strategy.

Although describing the outcome as positive, Dr. Galloway admitted that TNF tapering could be a tough sell to patients who have struggled to get control of their disease and abhor the thought of losing it.

“In fact,” he said, “about 40% of those we initially screened declined to go through with the study because they feared a relapse,” he said. “But I think many patients would consider this if we explain both the potential clinical and economic benefits, and reassure them that if they do flare, they can regain control rapidly on the same regimen that has been working for them.”

Dr. Galloway had no financial disclosures.

msullivan@frontlinemedcom.com

On Twitter @Alz_Gal