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

Dra. Natalia Borruel

Adacolumn® is mainly used in ulcerative colitis, also in Crohn’s disease, although it is less widespread, and we could use it in any patient profile, but usually the situation where we use Adacolumn® is in those patients in which we want to spare steroids, essentially. Adacolumn® has demonstrated in several studies that it is a steroid-sparing treatment or technique. Generally we use it as a bridge to another treatment. With patients who either have a contraindication or an adverse effect related to steroids, you need time to find another treatment that responds, for example, a biological treatment, and you use Adacolumn® to spare the cycle of steroids that we know has a lot of adverse effects. On other occasions we also use it as a bridge during a biological treatment while we wait for the biological treatment to have a response or, if we have achieved a partial response, until we achieve a complete response. These are often the most common situations where we use Adacolumn® as a bridge to another treatment or as a steroid-sparing treatment, when we have a clinical situation in which we don’t want to use them (steroids). It is, for example, very common to use it in patients with absolute or relative contraindications against the use of steroids or the increase of immunosuppression, for example transplanted or oncology patients, pregnant women, elderly patients or patients who have already had an infection that makes it unwise to increase their immunosuppression and, with Adacolumn® we know that this isn’t going to happen and that we are going to have the patient treated without adding more adverse effects.

References:

• M. Shiraki, T. Yamamoto. Steroid-sparing strategies in the management of ulcerative colitis: Efficacy of leukocytapheresis, World J Gastroenterol. 2012 Nov 7;18(41):5833-8.
• 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. 
• Cabriada JL, et al. Leukocytapheresis for steroid-dependent ulcerative colitis in clinical practice: results of a nationwide Spanish registry. J Gastroenterol. 2012 Apr;47(4):359-65.
• K. Yanagisawa, M. Murakami, Y. Kondo Efficacy and Safety of Adsorptive Granulocyte and Monocyte Apheresis in Elderly and Pregnant Patients With Ulcerative Colitis, Ther Apher Dial 2019;23(3):217-223.
• Yoko Yokoyama, Koji Sawada, Nobuo Aoyama,  et al:  Efficacy of Granulocyte and Monocyte Adsorptive Apheresis in Patients With Inflammatory Bowel Disease Showing Lost Response to Infliximab, Journal of Crohn’s and Colitis 2020,1-10.
• Rodríguez-Lago I, et al.: . Granulocyte-monocyte apheresis: an alternative combination therapy after Loss of response to anti-TNF agents in ulcerative colitis? Scand J Gastro 2019 Apr;54(4):459-464.

Rodríguez-Lago I, Benítez JM, Sempere L, Sáez-González E, Barreiro-de Acosta M, de Zárate JO, Cabriada JL. The combination of granulocyte-monocyte apheresis and vedolizumab: A new treatment option for ulcerative colitis? J Clin Apher. 2019 Dec;34(6):680-685.

Dr. Daniel Ginard

The patient profile has also been changing.

It has been changing because new treatment alternatives have been appearing. The most common classic indication was possibly that of the steroid-dependent patient to avoid the use of immunosuppressants or biologics. I think this is still an indication in some patients where, for safety reasons, because it’s not a very severe case, we believe that an alternative such as Adacolumn®, with a high safety profile, is more appropriate for these patients than using drugs. And we can continue using it in these patients to correct or control the steroid-dependency.

Then there are other patient profiles. I think these profiles are the ones we are using the treatment for the most these days and would be patients where we are prioritizing safety. As we said previously, it’s a very safe treatment with a good safety profile, probably better than any other treatment. And, in patients where our priority is safety, either because the patient doesn’t want to take drugs, which may be an indication, or because the patient has a safety problem that prevents the use of certain drugs, example, patients with a history of recent neoplasm or comorbidities. And another good patient profile would be an elderly or very fragile patient in whom we have sufficient venous access to be able to do it and it’s a good alternative for avoiding drugs that have more side effects. And when I say this, I’m basically saying that it can be used both in Crohn’s disease and in ulcerative colitis, but the standard indication is ulcerative colitis, in the indications I’ve mentioned.

And in recent years, another appropriate indication has emerged, which is the patient who is being treated with biologics and has a partial response or loss of response to the drug, and adding Adacolumn® may allow a return to the objective of remission in these patients, while maintaining the biologic. In other words, it is used as an adjuvant, we are going to use it in combination to try to recover the effect that we’ve lost in these patients in relation to the biologic.

References:

• Cabriada JL, et al. Leukocytapheresis for steroid-dependent ulcerative colitis in clinical practice: results of a nationwide Spanish registry. J Gastroenterol. 2012 Apr;47(4):359-65.
• Hibi T, Sameshima Y, Sekiguchi Y, Hisatome Y et al.: Treating ulcerative colitis by Adacolumn therapeutic leucocytapheresis: clinical efficacy and safety based on surveillance of 656 patients in 53 centres in Japan Dig Liver Dis. 2009 Aug;41(8):570-7.
• Rodríguez-Lago I et al. Granulocyte-monocyte apheresis: an alternative combination therapy after loss of response to anti-TNF agents in ulcerative colitis. Scand J Gastroenterol. 2019 Apr;54(4):459-464.
• Dignass A, et al. Granulocyte/monocyte adsorptive apheresis for the treatment of therapy-refractory chronic active ulcerative colitis. Scand J Gastroenterol. 2018 Apr;53(4):442-448.
• Dignass A, et al. Safety and Efficacy of Granulocyte/Monocyte Apheresis in Steroid-Dependent Active Ulcerative Colitis with Insufficient Response or Intolerance to Immunosuppressants and/or Biologics [the ART Trial]: 12-week Interim Results. J Crohns Colitis. 2016 Jul;10(7):812-20.
• 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, 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.
• Tanaka T, Yamamoto T, Sawada K, Sacco R. Treatment options for children and adolescents with inflammatory bowel disease: is granulomonocytapheresis an effective alternative to drug therapy? Expert Rev Gastroenterol Hepatol. 2017 Aug;11(8):749-758.

Dra. Pilar Nós

The classic patient, let’s say the best profile for using Adacolumn®, is a steroid-dependent patient who also has an intolerance or a problem and, for safety reasons, you have to avoid the use of immunosuppressants or anti-TNF drugs. But today its use is also established in the paediatric population, where the aim is to avoid steroids at all costs. It is also used in fragile populations, in populations with a history of tumour, in comorbidities. These situations where you want to increase safety is where the use of this therapy has been profiled the most.

References:

• Cabriada JL, et al. Leukocytapheresis for steroid-dependent ulcerative colitis in clinical practice: results of a nationwide Spanish registry. J Gastroenterol. 2012 Apr;47(4):359-65.
• 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.
• Tarja Ruuska, Peter Küster, Lena Grahnquistet al. Efficacy and safety of granulocyte, monocyte/macrophage adsorptive in pediatric ulcerative colitis. World J Gastroenterol 2016 May 7; 22(17): 4389-4396.
• H. Rolandsdotter, M. Eberhardson, U.L Fagerberg, Y. Finkel Granulocyte and Monocyte Apheresis for Induction of Remission in Children With New Onset Inflammatory Bowel Colitis. J Pediatr Gastroenterol Nutr 2018 Jan;66(1):84-89.
• 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.
• T Tabuchi 1, H Ubukata, S Sato: Granulocytapheresis as a possible cancer treatment Anticancer Res. May-Jun 1995;15(3):985-90.

Dr. Eugeni Domènech

In addition to the use of GMA to those patients with loss of response or with a partial response to biological, therapies GMA can also be considered in those patients who are more fragile. So those patients with an increased risk of infections, like elderly people, malnourished people, or those patients with an increased risk of tumors, those with a recent history of tumors, can be safely treated with GMA without increasing the risk of infection and tumors that are associated with all immunosuppressant therapies.

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. 
• Yoko Yokoyama, Koji Sawada, Nobuo Aoyama,  et al:  Efficacy of Granulocyte and Monocyte Adsorptive Apheresis in Patients With Inflammatory Bowel Disease Showing Lost Response to Infliximab, Journal of Crohn’s and Colitis 2020,1-10.
• Rodríguez-Lago I, et al.: . Granulocyte-monocyte apheresis: an alternative combination therapy after Loss of response to anti-TNF agents in ulcerative colitis? Scand J Gastro 2019 Apr;54(4):459-464.
• 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. Iago Rodríguez Lago

The main indication of apheresis is usually steroid dependent, you see, but there are different situations and different patients with different ages or different histories of the disease. But we usually try to prioritize apheresis therapy in those patients with prior history of malignancy, especially in the first two, three to five years after malignancy, but also in elderly patients above 60 to 65 years old. There are those patients where we usually put before apheresis therapy, before another immunosuppressive or biological therapy, but also this depends obviously on the previous history of the patient and the experience with the other therapies. But we usually try to elderly patients or pressures patients with comorbidity. They’re usually more prone to the receiver apheresis therapy.

References:

• Cabriada JL, et al. Leukocytapheresis for steroid-dependent ulcerative colitis in clinical practice: results of a nationwide Spanish registry. J Gastroenterol. 2012 Apr;47(4):359-65.
• 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.
• 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.