Discontinuation of Immunosuppressants Safe in Patients with Lupus

VBCR - April 2014, Volume 3, No 2 - Lupus
Rosemary Frei, MSc

Whistler, BC—A Toronto team has succeeded in completely tapering three-quarters of the patients with whom they attempted this discontinuation of immunosuppressants. Their analysis suggests immunosuppressant tapering is most likely to succeed in patients who are in clinical remission, who are on a low dose of corticosteroids, and who are tapered slowly.

“You want to make sure the patient is clinically inactive—in remission—for at least a year and on no more than 7.5 mg per day of corticosteroids before you start tapering the im­muno­suppressants,” explained lead investigator Zahi Touma, MD, PhD, after his team presented the results at the 2014 Canadian Rheumatology Association Annual Meeting (Touma Z, et al. Canadian Rheumatology Association's 2014 annual meeting, Whistler, BC, Feb 28-Mar 1, 2014. Poster #214). “And if you plan the immunosuppressant taper, it’s better to proceed slowly, because we found that patients who were tapered rapidly were 61% more likely to flare.”

He also noted it is important to assess patients’ clinical status, lupus serological markers, and anti-DNA antibodies and complement levels at least every 3 months, to ensure they remain in remission. However, Dr Touma also said that some patients’ serological markers are not concordant with their lupus clinical status, somewhat complicating the process. “The main thing is you want to be sure that during the tapering of immunosuppressants, the patients’ serology isn’t getting worse,” he told Value-Based Care in Rheumatology. “More importantly, that clinically there aren’t any signs of flare.”

Immunosuppressants are used in patients with lupus to reduce disease activity and induce and maintain remission. In addition, they are used as steroid-sparing agents. However, they also have several drawbacks, pointed out Dr Touma, Assistant Professor of Medicine, Division of Rheumatology, University of Toronto Centre for Prognosis Studies in the Rheumatic Diseases. These include possible adverse events such as infections, gastrointestinal upset, cytopenias, amenorrhea, and alopecia, as well as an increased risk for hematologic malignancies. Therefore, Dr Touma’s team sought to determine whether immunosuppressant therapy can be stopped in patients who have achieved low disease activity or remission.

They focused on the outcomes of the 179 patients in the Toronto lupus cohort who had immunosuppressant-tapering attempts. These patients were treated between 1970 and 2012, and had no activity in the Systemic Lupus Erythematosus Disease Activity Index 2000 clinical parameters, no proteinuria, thrombocytopenia, or leukopenia. They also were not taking >7.5 mg of prednisone daily.

Ninety-one percent of the 179 patients were women with a total of 204 tapering attempts. Attempts were defined as at least a 25% reduction in immunosuppressant dose, with tapering not being done because of side effects. The patients’ mean age at the start of the attempts was 39 years and their average lupus duration was 11.2 years. Most (123) had been prescribed azathioprine, 42 were taking methotrexate, and 39 were on mycophenolate mofetil.

There were 101 complete-tapering attempts and 76 (75%) were successful. These patients had a mean time to immunosuppressant discontinuation of 1.7 years and none experienced flares during a mean follow-up time of 1.6 years. The other 25 patients had a mean time to attempted discontinuation of 0.9 years. A clinical flare was defined as the start of, or any increase in, either an immunosuppressant or prednisone.

The team calculated that there was an odds ratio of 1.61 for having a lupus flare among the patients tapered quickly versus those tapered more slowly.

Furthermore, 47% of the 103 partial-tapering attempts succeeded, and these patients had no flares during a mean follow-up time of 2.1 years after the successful partial taper. The investigators defined partial tapering of immunosuppressants as a dose reduction but not complete discontinuation, due to either a flare during tapering or the patient still being tapered at their last clinic visit.

Dr Touma told Value-Based Care in Rheumatology that he and his coinvestigators are now analyzing the characteristics of the patients who completely discontinued immunosuppressants, to further guide clinicians in selecting individuals who are the best candidates for successful tapering.

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