Nursing Management of Patients Receiving Ibrutinib for Steroid-Dependent/Refractory
Chronic Graft Versus Host Disease
Melissa Logue, ANP-BC1; Susan Stephenson, RN, BMT CN2; Lori Styles, MD3; Vijay Reddy, MD, PhD3; Corey S. Cutler, MD, MPH, FRCPC2; Madan Jagasia, MD, MBBS, MS4
1Vanderbilt University Medical Center, Nashville, TN, USA; 2Dana Farber Cancer Institute, Boston, MA, USA; 3Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA; 4Vanderbilt Ingram Cancer Center, Nashville, TN, USA
• Chronic graft versus host disease (cGVHD) is a life-threatening
complication of allogeneic stem cell transplantation with no
approved therapies if patients fail corticosteroids.1
• Ibrutinib, a first-in-class, once-daily inhibitor of Bruton’s
tyrosine kinase (BTK),2-4 is approved by the US FDA for the
treatment of adult patients with cGVHD after failure of 1 or
more lines of systemic therapy.
• Oncology nurses guide patient care and education on managing
their cGVHD symptoms while on ibrutinib treatment.5,6
• Our objective was to evaluate nursing practice patterns in
managing symptom burden, treatment-emergent adverse
effects (TEAEs), and concomitant medications in patients
receiving ibrutinib for cGVHD after failing at least 1 prior
• Multicenter, phase 1b/2 open-label study assessing the
safety and efficacy of ibrutinib in steroid-dependent/steroidrefractory
cGVHD patients who failed ≤3 lines of systemic
therapy (PCYC-1129-CA, NCT02195869)1 (Figure 1)
• Eligible patients (N=42 evaluable) with ≤3 prior regimens
for cGVHD received 420 mg/day ibrutinib until progressive
disease or intolerable toxicity.
Oncology Nurses and Managing Adverse Events
• Managed AEs and concomitant medications via an online
messaging system and study visit forms
• Managed TEAEs based on institutional guidelines at Vanderbilt
University Medical Center (Nashville, TN) and the Dana Farber
Cancer Institute (Boston, MA)
Patient Baseline Characteristics
• Ibrutinib (median treatment duration, 4.4 months [range,
0.2–24.9 months]) was administered to 42 patients (median
age, 56 years [range, 19–74]; 22/42 [52%] males) who had
failed a median of 2 prior cGVHD regimens (range, 1–3).
• Most patients (37/42, 88%) had cGVHD with multiple organs
involved, including mouth (36/42, 86%), skin (34/42, 81%),
gastrointestinal system (14/42, 33%), and liver (7/42, 17%).
• Ibrutinib produced a high rate of response based on 2005
(with updates to align with 2014) NIH cGVHD response
criteria,7,8 with clinically meaningful improvement in Lee
Symptom Scale Scores across multiple organ domains
—— 9/28 (32%) of responders had a complete response; the
rate of sustained response for ≥20 weeks (5 months) was
71% (20/28 responders).
—— Overall, 26/42 patients (62%) achieved corticosteroid
doses <0.15 mg/kg/d by Week 52 while on ibrutinib;
5/28 responders (18%) were able to discontinue all
• Oncology nurses assessed cGVHD symptoms using a
scorecard based on NIH cGVHD consensus panel response
criteria for multiple organ domains.
• Oncology nurses managed common TEAEs that occurred
with ibrutinib treatment according to institution-specific
recommendations (Figure 3, Table 1); no patients experienced
major hemorrhagic TEAEs. Follow USPI recommendations
to manage hemorrhage risk.
• Nurses guided patient education on concomitant medications,
including cytochrome P450 (CYP) 3A inhibitors (Figure 4),
anticoagulants, and antiplatelet drugs.
• Patients were taking a median of 13 concomitant medications
within the first 10 days of study drug administration, including
prednisone (100%), Bactrim (79%), acyclovir (71%), and
—— 8/42 patients (19%) took anticoagulants, and 9/42 (21%)
took antiplatelet drugs.
—— 10/42 patients (24%) were taking strong CYP3A inhibitors
and 20/42 patients (48%) were taking moderate CYP3A
inhibitors during the study.
—— 22/42 patients (52%) were taking immunosuppressants at
baseline, including tacrolimus (33%) and mycophenolate
• Oncology nurses guided patients through their symptom
management during ibrutinib treatment for cGVHD
according to nursing best practice at individual institutions.
• In the study described here, ibrutinib therapy was tolerated
and resulted in clinically meaningful and sustained responses
in patients who had failed 1 to 3 prior treatment(s) for cGVHD.
—— AEs were consistent with those previously reported for
ibrutinib and those reported in patients with cGVHD on
—— ORR was 67%; 71% of responders had a sustained response
of ≥20 weeks.
—— Patients experienced reductions in corticosteroid doses
while on ibrutinib.
—— Patients with multiple organ involvement generally
showed responses in ≥2 organs.
• Managing TEAEs and concomitant medications by oncology
nurses requires ongoing communication between healthcare
providers and patients.
1. Miklos D, et al. Blood. 2017;130(21):2243-50.
2. Dubovsky JA, et al. J Clin Invest. 2014;124(11):4867-76.
3. Ryan CE, et al. Blood. 2016;128(25):2899-908.
4. Blazar BR, et al. Nat Rev Immunol. 2012;12(6):443-58.
5. Brown C. A Guide to Oncology Symptom Management. 2nd ed. Pittsburg, PA: ONS;
6. Lee S, et al. Biol Blood Marrow Transplant. 2002;8(8):444-52.
7. Pavletic SZ, et al. Biol Blood Marrow Transplant. 2006;12(3):252-66.
8. Lee SJ, et al. Biol Blood Marrow Transplant. 2015;21(6):984-99.
9. IMBRUVICA® (ibrutinib) prescribing information. Sunnyvale, CA: Pharmacyclics LLC;
ML and SS: no relevant disclosures; LS: is employed by Pharmacyclics LLC, an AbbVie
Company, and has stock ownership in AbbVie; VR: is employed by and serves a leadership
role with Pharmacyclics LLC, an AbbVie Company; has stock ownership in AbbVie, and
has received travel expenses from Pharmacyclics LLC, an AbbVie Company, and Janssen;
CSC: has served in a consulting or advisory role for Astellas, Bristol-Myers Squibb, Incyte,
Kite, Pfizer, and Pharmacyclics LLC, an AbbVie Company; MJ: has served in a consulting or
advisory role and has received research funding from Janssen and Therakos.
We thank the patients who participated in the study and their supportive
families, as well as the investigators and clinical research staff from the study
centers. This study was sponsored by Pharmacyclics LLC, an AbbVie Company.
The authors also thank Stephen Chang, PhD, from Pharmacyclics LLC, an
AbbVie Company, for statistical analysis. Medical writing support was provided
by Danielle L. Ippolito, PhD, and funded by Pharmacyclics LLC, an AbbVie
Poster presented at the Oncology Nursing Society (ONS) Annual Meeting, May 17-20, 2018, Washington, DC, USA.