For US Healthcare Professionals Only
For US Healthcare Professionals Only
When managing our patients, we do not delay treatment. We take an aggressive approach and intervene with Jakafi at the first signs of initial treatment failure to not let cGVHD smolder over time.
Preet M. Chaudhary, MD, PhD
GVHD Expert
of patients with moderate cGVHD at baseline had an overall response with Jakafi at week 24 vs 32.5% with BAT1
aORR was defined as the proportion of patients with CR or PR at week 24, according to 2014 NIH consensus criteria.1
bOne-sided P value, OR, and 95% CI were calculated using stratified Cochran-Mantel-Haenszel test, stratifying for moderate and severe cGVHD.1
cDefined as the proportion of patients who achieved CR or PR through week 24 (cycle 7, day 1), according to 2014 NIH consensus criteria.3
more likely to achieve an overall response at week 24 vs BAT (OR, 2.99)1
weeks (range: 2-24) with Jakafi and 4 weeks (range: 2-25) with BAT2
*The 74% value is based on the number of patients treated with BAT (n=158). ORRs for the remaining BATs were 20% (1/5) for everolimus, 25% (2/8) for imatinib, 20% (1/5) for infliximab, 30% (3/10) for low-dose MTX, 16.7% (1/6) for rituximab, and 28.6% (2/7) for sirolimus.1,4
†REACH3 was not powered to compare ORR for Jakafi to individual BATs.
BAT=best available therapy; cGVHD=chronic graft-versus-host disease; CI=confidence interval; CR=complete response; ECP=extracorporeal photopheresis; MMF=mycophenolate mofetil; MTX=methotrexate; NIH=National Institutes of Health; OR=odds ratio; ORR=overall response rate; PR=partial response; REACH=Ruxolitinib in patiEnts with refrACtory graft-versus-Host disease after allogeneic stem cell transplantation.
*Organ involvement at baseline for all patients (N=329): skin (71.1%), mouth (60.8%), eyes (57.4%), lungs (42.9%), joints and fascia (27.4%), liver (24.9%), GI tract (22.8%), genital tract (9.4%), missing (0.3%). Organ involvement was based on NIH consensus staging criteria at screening. A score of ≥1 was counted as organ involvement. Patients with missing assessments of single organs were counted as having no organ involvement for the organ assessed.1
aCrossover from BAT to Jakafi was permitted on or after week 24 if patients progressed, had a mixed or unchanged response, developed toxicity to BAT, or experienced a cGVHD flare. 61 patients crossed over to Jakafi after week 24. 72% of those who crossed over remained on Jakafi longer than 24 weeks.1,2
bBAT was chosen by the investigator prior to randomization: Options included ibrutinib, ECP, low-dose MTX, MMF, rituximab, everolimus, sirolimus, imatinib, infliximab, and pentostatin.3
cDefined as the proportion of patients with CR or PR at week 24.1
dDefined as the earliest time from date of randomization to relapse or recurrence of underlying disease or death due to underlying disease, nonrelapse mortality, or addition or initiation of another systemic therapy for cGVHD.1
eDefined as a ≥7-point reduction from baseline in total symptom score on the mLSS, which measures the symptoms of cGVHD on a scale of 0 to 100, with higher scores indicating worse symptoms.1
BAT=best available therapy; BID=twice daily; cGVHD=chronic graft-versus-host disease; CNI=calcineurin inhibitor; CR=complete response; ECP=extracorporeal photopheresis; FFS=failure-free survival; GI=gastrointestinal; mLSS=modified Lee Symptom Scale; MMF=mycophenolate mofetil; MTX=methotrexate; NIH=National Institutes of Health; ORR=overall response rate; PR=partial response; REACH=Ruxolitinib in patiEnts with refrACtory graft-versus-Host disease after allogeneic stem cell transplantation; SD=steroid-dependent; SR=steroid-refractory.
BAT=best available therapy; cGVHD=chronic graft-versus-host disease; CI=confidence interval; CR=complete response; FFS=failure-free survival; OR=odds ratio; ORR=overall response rate; PR=partial response; REACH=Ruxolitinib in patiEnts with refrACtory graft-versus-Host disease after allogeneic stem cell transplantation.
References: 1. Zeiser R, Polverelli N, Ram R, et al; for the REACH3 Investigators. Ruxolitinib for glucocorticoid-refractory chronic graft-versus-host disease. N Engl J Med. 2021;385(3):228-238. Supplementary appendix available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2033122. 2. Data on file. Incyte Corporation. Wilmington, DE. 3. Jakafi [package insert]. Wilmington, DE: lncyte Corporation. 4. Locatelli F; for the REACH3 Study Group. Ruxolitinib vs best available therapy in patients with steroid-refractory/dependent chronic graft-vs-host disease: subgroup analyses of overall response rate in the phase 3 REACH3 trial. Presented at: 47th Annual Meeting of the EBMT; March 14-17. 2021; Rome, Italy.
Indications and Usage
Jakafi® (ruxolitinib) is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF in adults.
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.
Indications and Usage
Jakafi® (ruxolitinib) is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea.
Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF in adults.
Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older.
Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.
Important Safety Information
Please see Full Prescribing Information for Jakafi.