MAGIC Criteria for Acute Graft-Versus-Host Disease (GVHD)

Grading can help guide decisions on treatment initiation and when alternative treatment should be considered.^1,2

References

1. Nassereddine S, Rafei H, Elbahesh E, et al. Acute graft versus host disease: a comprehensive review. Anticancer Res. 2017;37(4):1547-1555.

2. Martin PJ, Rizzo JD, Wingard JR, et al. First- and second-line systemic treatment of acute graft-versus-host disease: recommendations of the American Society of Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2012;18(8):1150-1163.

3. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.

REACH2 Study Population

REACH2 enrolled a population with Grades II–IV acute graft-versus-host disease (GVHD) in all affected organs.

aGVHD, acute graft-versus-host disease.

^aAll patients in REACH2 were located outside the US.^1
bAn increase in the steroid dose to ≥2 mg/kg/d methylprednisolone or prednisone equivalent or inability to taper the dose to <0.5 mg/kg/d methylprednisolone or prednisone equivalent for a minimum of 7 days.^1
cSeven patients with Grade 0 or Grade I aGVHD were randomized in error and were flagged as having a protocol deviation.¹

References

1. Zeiser R, von Bubnoff N, Butler J, et al. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease. N Engl J Med. 2020;382(19):1800-1810.

2. Zeiser R, von Bubnoff N, Butler J, et al. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease [supplementary appendix]. N Engl J Med. 2020;382(19):1800-1810.

Duration of Response With Jakafi^® (ruxolitinib) Compared With Control Therapy

Estimated cumulative incidence of loss of response data were not statistically significant.

^aDuration of response was defined as time from first response to acute GVHD progression or the addition of new systemic therapy for acute GVHD.^1
bCompeting risks were death without previous observation of progression of acute GVHD and the onset of chronic GVHD.¹

Reference

1. Zeiser R, von Bubnoff N, Butler J, et al. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease. N Engl J Med. 2020;382(19):1800-1810.

Median Failure-Free Survival With Jakafi^® (ruxolitinib) Compared With Control Therapy

Median failure-free survival (FFS) with Jakafi was 5 months and was one month with control therapy.¹

• The cumulative incidence of cancer relapse or progression at 18 months was 13% with Jakafi and 19% with control therapy¹
• The cumulative incidence of non-relapse-related death at 18 months was 49% with Jakafi and 51% with control therapy¹

• Jakafi has not been demonstrated to improve survival outcomes in steroid-refractory aGVHD
• REACH2 was not designed to compare survival probabilities between Jakafi and control therapy

Failure-free survival data were not statistically significant.

FFS, failure-free survival; HR, hazard ratio.

^aDefined as time from randomization to relapse or progression of hematologic disease, non–relapse-related death, or addition of new systemic therapy for aGVHD. Competing risk was the onset of chronic GVHD.^1
bHazard ratio is for relapse or progression of hematologic disease, non–relapse-related death, or addition of new systemic therapy for acute GVHD.¹

Reference

1. Zeiser R, von Bubnoff N, Butler J, et al. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease. N Engl J Med. 2020;382(19):1800-1810.

Responses With Jakafi by Day 28 Across All Grades Studied

In a subgroup analysis of overall response rate at day 28, all 13 patients with Grade II acute GVHD (aGVHD) at baseline responded to treatment with Jakafi, and over 40% of patients responded in each of the grade III and grade IV aGVHD groups.¹

ORR, overall response rate.

Reference

1. Jakafi Prescribing Information. Wilmington, DE: Incyte Corporation.