In which patient profiles is the use of maintenance Adacolumn® recommended?

Dr. Iago Rodríguez Lago

Once a patient has received induction therapy with apheresis, we reconsider if the patient is going to receive maintenance therapy with apheresis or not. When we are considering during this option, at least in our experience, we usually consider the benefits of the therapy and the safety. And sometimes we see patients with an age over 60 or 65 years and we consider that this is going to be safer than other therapies and we want to avoid new immunosuppressive therapy or a biological therapy. So, we prefer to maintain the patient on the apheresis, but also those patients with a prior history of malignancy, we also keep the patient of maintenance therapy. But there are different also scenarios, but probably some patient that has relapsing course with recurrent steroid treatments, they are considered of high risk of relapse. So sometimes we keep the patient for six months for example on maintenance therapy. So, the aim is to prevent the relapse. Sometimes the main objective is to keep this patient safe from other therapies and where the risk is higher of some adverse event and in other patients the risk of relapse is higher, so we are aiming of reducing the relapse and reducing the need of other therapies. So, depending on the context, we can consider these options.

References:

• Maiden L et al. Selective white cell apheresis reduces relapse rates in patients with IBD at significant risk of clinical relapse. Inflamm Bowel Dis. 2008 Oct;14(10):1413-8.
• Domènech, E., et al Use of granulocyte/monocytapheresis in ulcerative colitis: A practical review from a European perspective. World journal of gastroenterology, 2021 27(10), 908–918.
• Naganuma M et al; CAPTAIN study Group. Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial. J Gastroenterol. 2020 Apr;55(4):390-400.
• Ito A, T Omori , N Hanafusa et al. Efficacy and safety of granulocyte adsorption apheresis in elderly patients with ulcerative colitis. J Clin Apher. 2018 Aug;33(4):514- 520.
• S. Motoya , H. Tanaka, T. Shibuya et al. Safety and effectiveness of granulocyte and monocyte adsorptive apheresis in patients with inflammatory bowel disease in special situations: a multicentre cohort study.  BMC Gastroenterol 2019 Nov 21;19(1):196.

Dr. Daniel Ginard

I indicate maintenance treatment with Adacolumn® in patients who have a good response to the treatment but who after finishing the induction, quickly lose its effects and have symptoms again. We can sometimes recover the response in these patients by starting a maintenance treatment. In other words, if we can recover it, either with several consecutive doses of Adacolumn®, or one dose per week for three or four weeks, and we manage to recover the response in these patients, who we have already seen respond to the therapy but who lose this response when the treatment ends, we can recover this response and we can maintain it with a maintenance treatment. And I would offer these patients a monthly maintenance apheresis session for as long as it’s necessary.

References:

• Maiden L et al. Selective white cell apheresis reduces relapse rates in patients with IBD at significant risk of clinical relapse. Inflamm Bowel Dis. 2008 Oct;14(10):1413-8.
• Naganuma M et al; CAPTAIN study Group. Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial. J Gastroenterol. 2020 Apr;55(4):390-400.

Dra. Pilar Nós

I think Adacolumn is useful for maintenance, so in patients who have had a response, particularly if they are patients who have a prior heavy disease burden, who have had a low quality of life, frequent flare-ups, who have required hospitalisations or who have had an opportunistic infection. So, in all these situations, it is very difficult to suggest withdrawing the Adacolumn when they respond to it. Almost certainly you’re going to leave them with a maintenance treatment, which is usually one session per month, so you risk less with sporadic cycles or something like that. If the patient is a responder, a clear responder, who often comes from rocky ground, then it’s easy for them to stay on maintenance treatment.

References:

• Maiden L et al. Selective white cell apheresis reduces relapse rates in patients with IBD at significant risk of clinical relapse. Inflamm Bowel Dis. 2008 Oct;14(10):1413-8.
• Domènech, E., et al Use of granulocyte/monocytapheresis in ulcerative colitis: A practical review from a European perspective. World journal of gastroenterology, 2021 27(10), 908–918.
• Naganuma M et al; CAPTAIN study Group. Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial. J Gastroenterol. 2020 Apr;55(4):390-400.

Dra. Natalia Borruel

In patients in whom we have induced remission with Adacolumn® – fundamentally patients who are using it in combination with other drugs, frequently biologics – maintenance with Adacolumn® can be useful and, in fact, is useful in the first few months. We generally induce remission with more intensive regimens. Subsequently, gradually, depending on the patient’s course, we move on to a more spread out schedule, every two weeks, monthly or even every two months. The time at which we can stop the treatment with Adacolumn® depends very much on the patient’s evolution. Many times, even though they are already undergoing combination treatment, you stop the treatment with Adacolumn®, for example, one year after having started the induction, and you decide whether the patient’s evolution allows you to do so or not, or you need to restart the treatment and carry out maintenance. In clinical practice, as it is a very individualised treatment, there are patients who we keep on maintenance treatment for a long time, for months or even years.

References:

• Domènech, E., et al Use of granulocyte/monocytapheresis in ulcerative colitis: A practical review from a European perspective. World journal of gastroenterology, 2021 27(10), 908–918. 
• Cabriada, J.L., Rodríguez-Lago, I. Granulocitoaféresis en 2017. Puesta al día. Enfermedad Inflamatoria Intestinal 2017 (16) 2, 62-69.
• Naganuma M et al; CAPTAIN study Group. Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial. J Gastroenterol. 2020 Apr;55(4):390-400. 
• PRODIGGEST CLINICAL PRACTICE PROTOCOLS: Rational use of granulocytopheresis in inflammatory bowel disease 2019.
• Sakuraba A et al. An open-label prospective randomized multicenter study shows very rapid remission of ulcerative colitis by intensive granulocyte and monocyte adsorptive apheresis as compared with routine weekly treatment. Am J Gastroenterol. 2009 Dec;104(12):2990-5. 19724269.
• Fukuchi T, Kawashima K, Koga H, Utsunomiya R, Sugiyama K, Shimazu K, Eguchi T, Ishihara S. Induction of mucosal healing by intensive granulocyte/monocyte adsorptive apheresis (GMA) without use of corticosteroids in patients with ulcerative colitis: long-term remission maintenance after induction by GMA and efficacy of GMA re-treatment upon relapse. J Clin Biochem Nutr. 2022 Mar;70(2):197-204.

Dr. Eugeni Domènech

Maintenance therapy with GMA is still a controversial issue. There is scarce data dealing with maintenance therapy with GMA, but it has been recently published a randomized control trial that was performed in Japan in which GMA twice monthly was proved to be efficient in maintaining clinical remission in patients who had achieved clinical remission with leukocyte therapies. So, we have some evidence that we can use it. However, to date, in clinical practice, maintenance therapy with GMA is mainly restricted to those patients in whom other immunosuppressants are contraindicated or who have presented severe adverse effects to immunosuppressants.

References:

• Domènech, E., et al Use of granulocyte/monocytapheresis in ulcerative colitis: A practical review from a European perspective. World journal of gastroenterology, 2021 27(10), 908–918. 
• Cabriada, J.L., Rodríguez-Lago, I. Granulocitoaféresis en 2017. Puesta al día. Enfermedad Inflamatoria Intestinal 2017 (16) 2, 62-69.
• Naganuma M et al; CAPTAIN study Group. Efficacy of apheresis as maintenance therapy for patients with ulcerative colitis in an open-label prospective multicenter randomised controlled trial. J Gastroenterol. 2020 Apr;55(4):390-400. 
• PRODIGGEST CLINICAL PRACTICE PROTOCOLS: Rational use of granulocytopheresis in inflammatory bowel disease 2019.