SLE patients in remission safely stop immunotherapy

PARIS – When patients with lupus who were in remission on an immunosuppressant drug and a low dosage of prednisone stopped their immunosuppressant, 70% remained flare free 2 years off immunosuppressant treatment, in a review of 99 patients treated at one Canadian center.

Half of the patients were able to remain flare free off immunosuppressant treatment for at least 3 years, and patients who reached 3 years off treatment without flaring tended to remain stable, with a very low flare rate during 2 additional years of follow-up, Dr. Zahi Touma reported at the annual European Congress of Rheumatology.

The results "confirm that stopping immunosuppressants is possible in a selected group of lupus patients," Dr. Touma said in an interview. "Patients in clinical remission for at least 1 year and off corticosteroids or on small doses of 7.5 mg/day or less are appropriate candidates" for attempting to taper down and eventually withdraw immunosuppressant treatment, said Dr. Touma of the division of rheumatology at the University of Toronto.

"There are no guidelines on how or when to taper and stop immunosuppressants in lupus patients. At present, it is all individual physician preference. In the Toronto Lupus Clinic, in patients with clinically inactive lupus, we first aim to stop corticosteroids or reach a dose of no more than 7.5 mg/day before tapering immunosuppressants.

"Both physician and patient should agree on immunosuppressant withdrawal and discuss the possible consequences of this approach. In our study, among the 99 patients studied, 25 flared within 2 years, and 17 patients experienced a flare after year 2."

When a flare occurs in these patients, they usually restart standard of care treatment, with a corticosteroid or an immunosuppressant or both. The new study did not follow outcomes in patients who flared and then restarted standard treatment, but Dr. Touma noted that "in our clinical practice, we have witnessed patients who achieved remission after flaring, although this has not been specifically addressed in this study." He also was not sure how often patients in routine community practice who meet these criteria attempt to taper down and withdraw immunosuppressant treatment because of the lack of evidence supporting this approach.

The results also showed that a more gradual tapering down of the immunosuppressant dosage linked with a more durable remission once patients were completely off the immunosuppressant. "We have shown that the rate of flare after stopping immunosuppressants was lower in the group of patients who tapered gradually versus faster," Dr. Touma said. "In our center, we aim to taper by 25% from the baseline dose of immunosuppressant in stages, reducing by 25% every 3-6 months so that complete withdrawal is accomplished over 1-2 years."

The review included 1,678 patients with lupus seen at the Toronto Lupus Clinic, of whom 973 ever received immunosuppressant-drug treatment, and 99 of whom reached remission while on a prednisone dosage of 7.5 mg/day or less and also had no proteinuria or lupus-related thrombocytopenia or leucopenia. More than half of these 99 patients had been maintained on azathioprine prior to stopping their immunosuppressant drug, with smaller numbers of patients maintained on either methotrexate or mycophenolate mofetil.

After 2 years, 25 of the 99 patients had flared, which worked out to a 30% flare rate in a Kaplan-Meier analysis. In the same analysis, 46% of patients flared after 3 years off treatment, and 51% by 5 years off treatment. Patients who were serologically active at the time they stopped immunosuppressant therapy were more likely to flare, but Dr. Touma did not suggest using this as a criterion to select patients to withdraw from treatment.

Dr. Touma said that he had no disclosures.

[email protected]

On Twitter @mitchelzoler

PARIS – When patients with lupus who were in remission on an immunosuppressant drug and a low dosage of prednisone stopped their immunosuppressant, 70% remained flare free 2 years off immunosuppressant treatment, in a review of 99 patients treated at one Canadian center.

Half of the patients were able to remain flare free off immunosuppressant treatment for at least 3 years, and patients who reached 3 years off treatment without flaring tended to remain stable, with a very low flare rate during 2 additional years of follow-up, Dr. Zahi Touma reported at the annual European Congress of Rheumatology.

The results "confirm that stopping immunosuppressants is possible in a selected group of lupus patients," Dr. Touma said in an interview. "Patients in clinical remission for at least 1 year and off corticosteroids or on small doses of 7.5 mg/day or less are appropriate candidates" for attempting to taper down and eventually withdraw immunosuppressant treatment, said Dr. Touma of the division of rheumatology at the University of Toronto.

"There are no guidelines on how or when to taper and stop immunosuppressants in lupus patients. At present, it is all individual physician preference. In the Toronto Lupus Clinic, in patients with clinically inactive lupus, we first aim to stop corticosteroids or reach a dose of no more than 7.5 mg/day before tapering immunosuppressants.

"Both physician and patient should agree on immunosuppressant withdrawal and discuss the possible consequences of this approach. In our study, among the 99 patients studied, 25 flared within 2 years, and 17 patients experienced a flare after year 2."

When a flare occurs in these patients, they usually restart standard of care treatment, with a corticosteroid or an immunosuppressant or both. The new study did not follow outcomes in patients who flared and then restarted standard treatment, but Dr. Touma noted that "in our clinical practice, we have witnessed patients who achieved remission after flaring, although this has not been specifically addressed in this study." He also was not sure how often patients in routine community practice who meet these criteria attempt to taper down and withdraw immunosuppressant treatment because of the lack of evidence supporting this approach.

The results also showed that a more gradual tapering down of the immunosuppressant dosage linked with a more durable remission once patients were completely off the immunosuppressant. "We have shown that the rate of flare after stopping immunosuppressants was lower in the group of patients who tapered gradually versus faster," Dr. Touma said. "In our center, we aim to taper by 25% from the baseline dose of immunosuppressant in stages, reducing by 25% every 3-6 months so that complete withdrawal is accomplished over 1-2 years."

The review included 1,678 patients with lupus seen at the Toronto Lupus Clinic, of whom 973 ever received immunosuppressant-drug treatment, and 99 of whom reached remission while on a prednisone dosage of 7.5 mg/day or less and also had no proteinuria or lupus-related thrombocytopenia or leucopenia. More than half of these 99 patients had been maintained on azathioprine prior to stopping their immunosuppressant drug, with smaller numbers of patients maintained on either methotrexate or mycophenolate mofetil.

After 2 years, 25 of the 99 patients had flared, which worked out to a 30% flare rate in a Kaplan-Meier analysis. In the same analysis, 46% of patients flared after 3 years off treatment, and 51% by 5 years off treatment. Patients who were serologically active at the time they stopped immunosuppressant therapy were more likely to flare, but Dr. Touma did not suggest using this as a criterion to select patients to withdraw from treatment.

Dr. Touma said that he had no disclosures.

[email protected]

On Twitter @mitchelzoler

PARIS – When patients with lupus who were in remission on an immunosuppressant drug and a low dosage of prednisone stopped their immunosuppressant, 70% remained flare free 2 years off immunosuppressant treatment, in a review of 99 patients treated at one Canadian center.

Half of the patients were able to remain flare free off immunosuppressant treatment for at least 3 years, and patients who reached 3 years off treatment without flaring tended to remain stable, with a very low flare rate during 2 additional years of follow-up, Dr. Zahi Touma reported at the annual European Congress of Rheumatology.

The results "confirm that stopping immunosuppressants is possible in a selected group of lupus patients," Dr. Touma said in an interview. "Patients in clinical remission for at least 1 year and off corticosteroids or on small doses of 7.5 mg/day or less are appropriate candidates" for attempting to taper down and eventually withdraw immunosuppressant treatment, said Dr. Touma of the division of rheumatology at the University of Toronto.

"There are no guidelines on how or when to taper and stop immunosuppressants in lupus patients. At present, it is all individual physician preference. In the Toronto Lupus Clinic, in patients with clinically inactive lupus, we first aim to stop corticosteroids or reach a dose of no more than 7.5 mg/day before tapering immunosuppressants.

"Both physician and patient should agree on immunosuppressant withdrawal and discuss the possible consequences of this approach. In our study, among the 99 patients studied, 25 flared within 2 years, and 17 patients experienced a flare after year 2."

When a flare occurs in these patients, they usually restart standard of care treatment, with a corticosteroid or an immunosuppressant or both. The new study did not follow outcomes in patients who flared and then restarted standard treatment, but Dr. Touma noted that "in our clinical practice, we have witnessed patients who achieved remission after flaring, although this has not been specifically addressed in this study." He also was not sure how often patients in routine community practice who meet these criteria attempt to taper down and withdraw immunosuppressant treatment because of the lack of evidence supporting this approach.

The results also showed that a more gradual tapering down of the immunosuppressant dosage linked with a more durable remission once patients were completely off the immunosuppressant. "We have shown that the rate of flare after stopping immunosuppressants was lower in the group of patients who tapered gradually versus faster," Dr. Touma said. "In our center, we aim to taper by 25% from the baseline dose of immunosuppressant in stages, reducing by 25% every 3-6 months so that complete withdrawal is accomplished over 1-2 years."

The review included 1,678 patients with lupus seen at the Toronto Lupus Clinic, of whom 973 ever received immunosuppressant-drug treatment, and 99 of whom reached remission while on a prednisone dosage of 7.5 mg/day or less and also had no proteinuria or lupus-related thrombocytopenia or leucopenia. More than half of these 99 patients had been maintained on azathioprine prior to stopping their immunosuppressant drug, with smaller numbers of patients maintained on either methotrexate or mycophenolate mofetil.

After 2 years, 25 of the 99 patients had flared, which worked out to a 30% flare rate in a Kaplan-Meier analysis. In the same analysis, 46% of patients flared after 3 years off treatment, and 51% by 5 years off treatment. Patients who were serologically active at the time they stopped immunosuppressant therapy were more likely to flare, but Dr. Touma did not suggest using this as a criterion to select patients to withdraw from treatment.

Dr. Touma said that he had no disclosures.

[email protected]

On Twitter @mitchelzoler