Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

Abstract

AIM:To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis. METHODS:In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption.RESULTS: N i n e p a t i e n t s w e r e r a n d o m i z e d t o 5 granulocyteaphaeresis sessions (group 1) and 11 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year followup. One serious adverse event, not related to the study therapy, was reported. CONCLUSION:Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect.

Leukocytapheresis for steroid-dependent ulcerative colitis in clinical practice: results of a nationwide Spanish registry

“…2 Long-term remission rates during follow-up regarding the use of periodical apheresis as maintenance therapy among initial responders median of 30 mg/day) in inducing clinical remission at week 12. Our results regarding effectiveness are in agreement with previous data showing that more than one third of patients achieved sustained clinical remission [11][12][13][14]25]. In that setting, apheresis was found to be superior to increasing the steroid dose in inducing clinical remission.…”

“…There is controversy on the impact of the number and/or the frequency of apheresis sessions on clinical efficacy. Whereas some studies suggest that these issues may be relevant [29,30], some others point to a little or minimal impact, as in our study [13,14]. In this sense, the concomitant use of steroids might be a critical issue.…”

“…In fact, the outcomes of some large European case series have already been reported, reflecting the confidence of some gastroenterologists with apheresis [24]. Noteworthily, European efforts have been particularly focused on steroid-dependent UC [11][12][13][14]25], a scenario where apheresis seems to be more efficient compared to severe or refractory flare-ups of the disease [26]. The present study, also focused on steroid-dependent UC, adds valuable information from a large cohort treated in clinical practice.…”

“…In steroid-dependent disease, the concomitant use of steroids may improve the initial clinical outcome as long as they act as a bridge to the therapeutic effect of apheresis itself. This may explain why, in this clinical setting, reported remission rates have been similar despite the number of apheresis sessions [13,14]. From the initial apheresis experience in Spain in which a high steroid dose was used at the start of apheresis therapy [12], concomitant steroids are usually maintained and slowly tapered until the last apheresis session.…”

“…According to this point of view, removal of activated inflammatory cells from the bloodstream seems an appealing mechanism to reduce mucosal inflammation in UC patients. In fact, several mechanisms of action of leukocytapheresis in inflammatory bowel disease have been recently proposed and reviewed [10], and some open trials and prospective series suggest the usefulness of this therapy in patients with steroid-dependent UC [11][12][13][14]. Moreover, the excellent safety profile of leukocytapheresis presents an additional argument for its use in patients that have already been exposed to the severe side effects of corticosteroids.…”