Development of an ambulatory infusion protocol for Abatacept

The treatment strategies for patients with rheumatological disorders have changed over the past several years with the advent of biologics and the incorporation of treat to target strategies to improve disease outcomes (Consolaro et al. 2012). The increased use of biologics has created a need to develop streamlined order sets and nursing protocols for infusions. Abatacept is a CTLA4 immunoglobulin fusion protein that inhibits T cell responses by competing for co-stimulatory ligands (Bristol-Myers Squibb 2006) and is used in poly-articular juvenile rheumatoid arthritis (JIA). This drug has been approved for use in JIA patients who have had an inadequate response to disease modifying anti-rheumatic drugs and one other immunosuppressive biologic such as a tumor necrosis factor inhibitor or an anti-interleukin 6 agent (Vital and Emery 2006; Ministry of Health and Long-Term Care Exceptional Access Program (EAP) (2017).

Common Variable Immune Deficiency (CVID) is a heterogeneous primary immunodeficiency characterized by antibody deficiency, infections, autoimmunity, and lymphoproliferation (Resnick et al. 2012). Molecular diagnosis of the genetic causes of CVID have identified that mutations in the LRBA gene (encoding the lipopolysaccharide-responsive and beige-like anchor protein) and CTLA4 (cytotoxic T lymphocyte antigen-4) may cause the clinical syndrome of CVID with significant autoimmunity including: type 1 diabetes, severe interstitial lung disease, gastrointestinal disease, and autoimmune cytopenias (Lo et al. 2015).

Increasingly, there are reports that patients with a CVID phenotype and mutations in LRBA or CTLA4 have significant improvement of their autoimmune symptoms following treatment with Abatacept (Orencia) (Lo et al. 2015). Patients were shown to have improvement in their overall clinical well-being, inflammatory markers, and their CT scans and pulmonary function tests showed rapid and dramatic improvement. Patients were also shown to have had minimal infectious or autoimmune complications over 5 to 8 years of treatment (Lo et al. 2015).

We present the development of the Abatacept order set and nursing checklist (Appendix 1) that has been used for biologics in pediatric rheumatology patients and propose that this process for protocol development is one that may be applied to immunodeficient patients with autoimmunity, as biologically medications are added to their treatment regimes.

The infusion protocol was developed as a resource for the medical and nursing teams involved with the out-patient infusion clinic at the Hospital for Sick Children, Toronto, Ontario. The infusion orders are embedded within the protocol and were necessary to develop for the out-patient area since drug ordering, access, and funding are different from the in-patient areas. The out-patient infusion centre sees a variety of patients from different departments and relies on updated and accurate information in order to provide safe care. In terms of safety, consideration to work load and patient monitoring were priorities and needed to be vetted by the healthcare teams involved.

The methods used in the development of this protocol included a review of different established infusion protocols already in place and a review of the product monograph from the drug manufacturer. Extensive vetting within the Division of Rheumatology and a review by the hospital’s “forms committee” helped to finalize the protocol. Once the protocol was finalized, staff education programs were developed by partnering with representatives from the Abatacept Patient Support Program to provide in-service education opportunities for nurses, physicians and pharmacists prior to the implementation of the protocol (Appendix 1).

The careful review of established protocols for biologics and partnering with the drug manufacturer to provide protocol specific information contributed to a successful launch of the treatment protocol for Abatacept. This protocol is now the standard of care for use in the outpatient area. This protocol has been adopted for use as well by several community colleagues, hospitals and other departments within the hospital, which allows for patients to receive consistency of treatment in multiple settings. The process used for the development of this protocol may be applied to other biologics as they become increasingly recognized as treatment options for immunodeficient patients.