The first FDA-approved treatment that studied efficacy and safety in previously treated adult cGVHD1,2*

An open-label, multicenter, single-arm, Phase 1b/2 trial1,3

The 1129 study was designed to allow for the tapering of systemic steroids as clinically indicated.3,4†

Nearly 90% of patients had ≥2 organs involved1,3

Select patient characteristics1,3

Responses were assessed by investigators using the 2005 NIH Consensus Panel Response Criteria with two modifications (added “not evaluable” for organs with non-cGVHD abnormalities, and organ score change from 0 to 1 was not considered disease progression) to align with the updated 2014 NIH Consensus Panel Response Criteria.1

One of the secondary objectives evaluated was corticosteroid changes over time, which also allowed for an increase of dose if necessary.3,4

Prednisone or prednisone equivalent.1

§52% of patients were receiving immunosuppressants including tacrolimus (n=14; 33.3%), mycophenolate mofetil (n=4; 9.5%), cyclosporin (n=3; 7.1%), sirolimus (n=3; 7.1%), and extracorporeal photopheresis (n=1; 2.4%).3

cGVHD=chronic graft versus host disease, FDA=US Food and Drug Administration, NIH=National Institutes of Health.

References: 1IMBRUVICA® (ibrutinib) Prescribing Information. 2US Food and Drug Administration. FDA approves treatment for chronic graft versus host disease. Published August 2, 2017. Accessed May 23, 2019. 3Data on file. 4Miklos D, Cutler CS, Arora M, et al. Ibrutinib for chronic graft-versus-host disease after failure of prior therapy. Blood. 2017;130(21):2243-2250.