In steroid-refractory acute and chronic GvHD, only JAKAVI provides superior efficacy vs BAT¹

In the REACH2 trial JAKAVI delivered a significant and sustained overall response rate (ORR) for acute GvHD patients¹

BAT, best available therapy; ORR, overall response rate.

Results from a phase 3, multicenter, randomised, open-label trial. Eligible patients ≥12 years of age were randomised in a 1:1 ratio to treatment with JAKAVI 10 mg BID or commonly used options (at the investigators’ discretion). Crossover to JAKAVI was permitted of patients who had no response at day 28, or if they had a loss of response thereafter, received additional systemic therapy, and did not have signs of chronic GvHD. Thirty-two percent of patients crossed over to JAKAVI on or after Day 28.²

*BAT was selected by the investigator on a patient-by-patient basis and included anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), mesenchymal stromal cells (MSC), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, or infliximab.¹

JAKAVI extended failure-free survival (FFS)²

JAKAVI improved overall survival (OS)³

JAKAVI enhanced mean QoL scores for more aGvHD patients⁴

QoL, quality of life; EQ-5D-5L, EuroQol 5 Dimension 5 Level.

In the REACH3 trial JAKAVI significantly improved overall response rate (ORR) at week 24¹

Results from a Phase 3, open-label, multinational study in alloHSCT patients aged ≥12 years with moderate or severe cGvHD. Crossover was permitted on or after week 24 in patients who did not achieve or maintain complete or partial responses, developed toxicities, or had a cGvHD flare.⁵
*BAT was selected by the investigator on a patient-by-patient basis and included extracorporeal photopheresis (ECP), low dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, or ibrutinib.¹

JAKAVI delivered a higher best overall response (BOR) at any time⁵

*Best overall response is defined as best response at any point during treatment. Better adherence to NIH consensus response criteria in REACH3 than in previous studies may have resulted in lower overall responses with control therapy and JAKAVI than have been reported previously.⁵

JAKAVI provided higher overall response (OR) regardless of organ involvement⁶

JAKAVI extended patients’ failure-free survival (FFS)¹

JAKAVI reduced average steroid dose⁶

^aPatients who are completely tapered off steroids and are ongoing will be counted as having steroid dose=0 mg/kg/day until the end of the main treatment period or the restart of treatment with systemic steroids. Plot shows boxes (25th-75th percentiles) with median as horizontal line. The dots in the boxes and joint lines represent the mean values. Whiskers (vertical lines) extend to the 10th to 90th percentiles. Values outside this range are not displayed.^6
bDose of methylprednisolone was converted to prednisone equivalent.⁶
*Weight-normalised standardised glucocorticoid.

JAKAVI rapidly decreased symptom burden⁷

The modified LEE Symptom Score (mLSS) consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological) and assesses the QoL of cGvHD patients.⁶

Consistent benefits reported across multiple QoL scales⁷

According to the Patient Global Impression of Severity (PGIS) QoL scale:

References

1. JAKAVI^® (ruxolitinib) tablets: EU Summary of Product Characteristics. Novartis; January 2022.
2. Zeiser R, von Bubnoff N, Butler J, et al; REACH2 Trial Group. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease. N Engl J Med. 2020;382(19):1800-1810.
3. Zeiser R, von Bubnoff N, Butler J, et al; REACH2 Trial Group. Ruxolitinib for glucocorticoid-refractory acute graft-versus-host disease. Supplementary appendix. N Engl J Med. 2020;382(19):1-72.
4. Mohty M, on behalf of the REACH2 Study Group. Ruxolitinib vs Best Available Therapy in Patients With Steroid-Refractory Acute Graft-vs-Host Disease: 6-Month Follow-Up From the Randomized, Phase 3 REACH2 Study. Presentation given at: The 47th Annual Meeting of the European Society for Blood and Marrow Transplantation; March 14-17, 2021; Paris, France.
5. Zeiser R, Polverelli N, Ram R, et al; REACH3 Investigators. Ruxolitinib for glucocorticoid-refractory chronic graft-versus-host disease. N Engl J Med. 2021;385(3):228-238.
6. Zeiser R, Polverelli N, Ram R, et al; REACH3 Investigators. Ruxolitinib for glucocorticoid-refractory chronic graft-versus-host disease. Supplementary appendix. N Engl J Med. 2021;385(3):228-238.
7. Lee S, Locatelli F, Ayuk FA, et al. Patient-Reported Outcomes (PROs) Among Patients With Steroid-Refractory or -Dependent Chronic Graft-vs-Host Disease (cGVHD) Randomized to Ruxolitinib (RUX) vs Best Available Therapy (BAT). Presented at: 63rd ASH Annual Meeting and Exposition; Dec 11-14, 2021.