Burden on patients

man looking to his right with a neutral expression
man looking to his right with a neutral expression

Patients with cGVHD have poor QOL, regardless of disease severity1

The clinically significant reductions in QOL that can occur with all severity grades (mild through severe) of cGVHD may be underestimated by physicians.1

The burden of cGVHD is multifaceted, with patients experiencing poor QOL and progressive disability1,2,a

circular icon with bar graph showing decreasing quality-of-life (QOL) value

QOL scores across all domains are lower in patients with greater cGVHD severity1

  • Even patients with mild cGVHD symptoms in the lungs, GI tract and joints/fascia
    have clinically meaningful deterioration in physical QOL

aIn a national cross-sectional questionnaire study conducted in Japan, VAS scores were evaluated using 1140 pairs of patient and physician questionnaires. The data were collected from recipients of alloHCT for hematologic disease between 1995 and 2009. The VAS was used to assess the physical, psychological and social QOL of long-term survivors of alloHCT (median time post alloHCT of 7 years) who had various degrees of cGVHD severity.1

Although disability can be progressive,
early intervention can lessen the severity2,3

The potential for progressive disability with cGVHD was demonstrated in an analysis of data from 2 prospective, multicenter, observational studies from the Chronic GVHD Consortium.2

Development/progression of disabilityb following initiation of systemic therapy in patients with mostly moderate or severe cGVHD2

had no disability
at baseline
(n=197)

Of these patients,

50

%

developed a disability.

had disability
at baseline
(n=174)

Of these patients,

50

%

experienced progression of their disability.

bDisability was based on the Flowers criteria at enrollment vs month 18.2

Changes in disability correlated with decreases in human activity profile score—a self-reported measure of physical activity in adult patients—and Karnofsky performance status.2

Progressive disability was associated with2

  • Low ORRs, with 28% of patients achieving CR or PR (P <.0001)
  • The need for additional systemic therapy in 66% of patients (P <.0001)

The 2014 NIH cGVHD Consensus Criteria recommend vigilance in recognizing cGVHD progression and early intervention, which can prevent progression to more severe cGVHD.3

Risk factors for more severe manifestations of cGVHD include4

  • Older age, prior aGVHD, RIC and female donor to male recipient
  • In a retrospective single-center cohort study of patients who were diagnosed with AML and/or MDS and consecutively received a peripheral blood T-cell–depleted NMA alloHCT, moderate to severe cGVHD was associated with5
  • CD19+ cell count ≥82 x 106/kg in graft
  • CD3+ cell count ≥325 x 106/kg in graft
  • HLA antibodies in serum before transplant

A diverse range of patients

benefited from REZUROCK,

an effective and innovative dual inhibitor for the treatment of cGVHD.6

Explore the
rockstar study

aGVHD, acute graft-versus-host disease; alloHCT, allogeneic hematopoietic cell transplant; AML, acute myeloid leukemia; cGVHD, chronic graft-versus-host disease; CR, complete response; GI, gastrointestinal; HLA, human leukocyte antigen; MDS, myelodysplastic syndrome; MOA, mechanism of action; NIH, National Institutes of Health; NMA, nonmyeloablative; ORR, overall response rate; PR, partial response; QOL, quality of life; RIC, reduced-intensity conditioning; VAS, visual analog scale.

References: 1. Kurosawa S, Oshima K, Yamaguchi T, et al. Quality of life after allogeneic hematopoietic cell transplantation according to affected organ and severity of chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2017;23(10):1749-1758. doi:10.1016/j.bbmt.2017.06.011 2. Hamilton BK, Storer BE, Wood WA, et al. Disability related to chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2020;26(4):772-777. doi:10.1016/j.bbmt.2019.10.019 3. Jagasia MH, Greinix HT, Arora M, et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host-Disease:I. The 2014 Diagnosis and Staging Working Group report. Biol Blood Marrow Transplant. 2015;21(3):389-401.e1. doi:10.1016/j.bbmt.2014.12.001 4. Afram G, Pérez Simón JA, Remberger M, et al. Reduced intensity conditioning increases risk of severe cGVHD: identification of risk factors for cGVHD in a multicenter setting. Med Oncol. 2018;35(6):79. doi:10.1007/s12032-018-1127-2 5. Kok LMC, Bungener L, de Bock GH, et al. Risk factors associated with the development of moderate to severe chronic graft-versus-host disease after non-myeloablative conditioning allogeneic stem cell transplantation in patients with AML or MDS. Hum Cell. 2020;33(1):243-251. doi:10.1007/s13577-019-00297-7 6. REZUROCK. Package insert. Kadmon Pharmaceuticals, LLC; 2021.

Indication

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose

Adverse Reactions

The most common (≥ 20%) adverse reactions, including laboratory abnormalities, were infections, asthenia, nausea, diarrhea, dyspnea, cough, edema, hemorrhage, abdominal pain, musculoskeletal pain, headache, phosphate decreased, gamma glutamyl transferase increased, lymphocytes decreased, and hypertension

Permanent discontinuation of REZUROCK due to adverse reactions occurred in 18% of patients. The adverse reactions which resulted in permanent discontinuation of REZUROCK in > 3% of patients included nausea (4%). Adverse reactions leading to dose interruption occurred in 29% of patients. The adverse reactions leading to dose interruption in ≥ 2% were infections (11%), diarrhea (4%), and asthenia, dyspnea, hemorrhage, hypotension, liver function test abnormal, nausea, pyrexia, edema, and renal failure with (2% each)

Monitor total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at least monthly

Drug Interactions

Strong CYP3A Inducers: Coadministration of REZUROCK with strong CYP3A inducers decreases belumosudil exposure, which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with strong CYP3A inducers

Proton Pump Inhibitors: Coadministration of REZUROCK with proton pump inhibitors decreases belumosudil exposure, which may reduce the efficacy of REZUROCK. Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with proton pump inhibitors

Use in Specific Populations

Pregnancy: Based on findings from animal studies and the mechanism of action, REZUROCK can cause fetal harm when administered to pregnant women. There are no available human data on REZUROCK use in pregnant women to evaluate for a drug-associated risk. Advise pregnant women and females of reproductive potential of the potential risk to the fetus

Lactation: There are no data available on the presence of belumosudil or its metabolites in human milk or the effects on the breastfed child, or milk production. Because of the potential for serious adverse reactions from belumosudil in the breastfed child, advise lactating women not to breastfeed during treatment with REZUROCK and for at least one week after the last dose

Pediatric Use: The safety and effectiveness of REZUROCK have been established in pediatric patients 12 years and older. The safety and effectiveness of REZUROCK in pediatric patients less than 12 years old have not been established

Geriatric Use: Of the 186 patients with chronic GVHD in clinical studies of REZUROCK, 26% were 65 years and older. No clinically meaningful differences in safety or effectiveness of REZUROCK were observed in comparison to younger patients

Renal and Hepatic Impairment: Treatment with REZUROCK has not been studied in patients with pre-existing severe renal or hepatic impairment. For patients with pre-existing severe renal or hepatic impairment, consider the risks and potential benefits before initiating treatment with REZUROCK

Please see full Prescribing Information for additional Important Safety Information.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. You may also contact Kadmon Pharmaceuticals, LLC, at 1-877-377-7862 to report side effects.

Indication

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.

Important safety information Warnings and Precautions

Embryo-Fetal Toxicity: Based on findings in animals and its mechanism of action, REZUROCK can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with REZUROCK and for at least one week after the last dose

Indication & Important safety information

REZUROCKTM (belumosudil) is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.