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CLINICAL NEWS ibrutinib; the other five deaths occurred after the patients discontinued ibrutinib. In an accompanying exploratory biomarker analysis, the researchers found that pro-inflammatory, chemotactic, and fibrotic factors (including the cGVHD- associated biomarkers IFNγ, TNFα, IP-10, and CXCL9) decreased following ibrutinib therapy, “suggesting that ibrutinib could be impacting resolution of allogeneic inflam- mation at the cellular level,” the authors Two patients had a relapse of their underlying malignancy (one with acute lymphocytic leukemia and one with prolymphocytic leukemia). AEs led to dose reductions in 13 patients (31%) and treatment discontinuation in 14 patients (33%). Seven patients died during the study. Two deaths were related to AEs (multilobu- lar pneumonia and bronchopulmonary aspergillosis) while the patients were on The authors report financial support from Pharmacyclics LLC. explained. The study was limited by its single-arm design and small patient population. The authors added that a randomized, controlled trial comparing upfront treatment with ibrutinib or high-dose steroids in patients with cGVHD is underway. The study was supported by Pharma- cyclics LLC, a subsidiary of AbbVie (the manufacturers of ibrutinib). REFERENCE Miklos D, Cutler CS, Arora M, et al. Ibrutinib for chronic graft-versus-host disease after failure of prior therapy. Blood. 2017 September 18. [Epub ahead of print] T:7” REVLIMID ® [lenalidomide] capsules, for oral use Table 5: All Adverse Reactions in ≥5.0% and Grade 3/4 Adverse Reactions in ≥ 1.0% of Patients in the REVLIMID Vs Placebo Arms* Maintenance Study 1 All Adverse Reactions [a] Body System Adverse Reaction REVLIMID (N=224) n (%) Maintenance Study 2 Grade 3/4 Adverse Reactions [b] Placebo (N=221) n (%) REVLIMID (N=224) n (%) All Adverse Reactions [a] Grade 3/4 Adverse Reactions [b] Placebo (N=221) n (%) REVLIMID (N=293) n (%) Placebo (N=280) n (%) REVLIMID (N=293) n (%) Placebo (N=280) n (%) Blood and lymphatic system disorders Neutropenia c % 177 ( 79.0) 94 ( 42.5) 133 ( 59.4) 73 ( 33.0) 178 ( 60.8) 33 ( 11.8) 158 ( 53.9) 21 ( 7.5) Thrombocytopenia c % 162 ( 72.3) 101 ( 45.7) 84 ( 37.5) 67 ( 30.3) 69 ( 23.5) 29 ( 10.4) 38 ( 13.0) 8 ( 2.9) Leukopenia c 51 ( 22.8) 25 ( 11.3) 45 ( 20.1) 22 ( 10.0) 93 ( 31.7) 21 ( 7.5) 71 ( 24.2) 5 ( 1.8) Anemia 47 ( 21.0) 27 ( 12.2) 23 ( 10.3) 18 ( 8.1) 26 ( 8.9) 15 ( 5.4) 11 ( 3.8) 3 ( 1.1) Lymphopenia 40 ( 17.9) 29 ( 13.1) 37 ( 16.5) 26 ( 11.8) 13 ( 4.4) 3 ( 1.1) 11 ( 3.8) 2 ( 0.7) 1 ( 0.4) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 12 ( 4.1) 1 ( 0.4) 7 ( 2.4) 1 ( 0.4) 39 ( 17.4) 34 ( 15.4) 39 ( 17.4) 34 ( 15.4) 7 ( 2.4) 1 ( 0.4) 5 ( 1.7) 1 ( 0.4) Upper respiratory tract infection e 60 ( 26.8) 35 ( 15.8) 7 ( 3.1) 9 ( 4.1) 32 ( 10.9) 18 ( 6.4) 1 ( 0.3) 0 ( 0.0) Neutropenic infection 40 ( 17.9) 19 ( 8.6) 27 ( 12.1) 14 ( 6.3) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) Pancytopenia c d % Febrile neutropenia c Infections and Pneumonias* infestations # c % Bronchitis c Nasopharyngitis e 31 ( 13.8) 15 ( 6.8) 23 ( 10.3) 7 ( 3.2) 50 ( 17.1) 13 ( 4.6) 27 ( 9.2) 5 ( 1.8) 10 ( 4.5) 9 ( 4.1) 1 ( 0.4) 5 ( 2.3) 139 ( 47.4) 104 ( 37.1) 4 ( 1.4) 1 ( 0.4) 5 ( 2.2) 2 ( 0.9) 0 ( 0.0) 0 ( 0.0) 102 ( 34.8) 84 ( 30.0) 1 ( 0.3) 0 ( 0.0) Gastroenteritis c 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 66 ( 22.5) 55 ( 19.6) 6 ( 2.0) 0 ( 0.0) Rhinitis e 2 ( 0.9) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 44 ( 15.0) 19 ( 6.8) 0 ( 0.0) 0 ( 0.0) e 8 ( 3.6) 3 ( 1.4) 0 ( 0.0) 0 ( 0.0) 41 ( 14.0) 26 ( 9.3) 0 ( 0.0) 1 ( 0.4) Influenza c 8 ( 3.6) 5 ( 2.3) 2 ( 0.9) 1 ( 0.5) 39 ( 13.3) 19 ( 6.8) 3 ( 1.0) 0 ( 0.0) Sinusitis 21 ( 9.4) 2 ( 0.9) 19 ( 8.5) 2 ( 0.9) 9 ( 3.1) 4 ( 1.4) 1 ( 0.3) 0 ( 0.0) Lower respiratory tract infection e 13 ( 5.8) 5 ( 2.3) 6 ( 2.7) 4 ( 1.8) 4 ( 1.4) 4 ( 1.4) 0 ( 0.0) 2 ( 0.7) Infection c 12 ( 5.4) 6 ( 2.7) 9 ( 4.0) 5 ( 2.3) 17 ( 5.8) 5 ( 1.8) 0 ( 0.0) 0 ( 0.0) Urinary tract infection c d e 9 ( 4.0) 5 ( 2.3) 4 ( 1.8) 4 ( 1.8) 22 ( 7.5) 17 ( 6.1) 1 ( 0.3) 0 ( 0.0) Lower respiratory tract infection bacterial d 6 ( 2.7) 1 ( 0.5) 4 ( 1.8) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) Bacteremia d 5 ( 2.2) 0 ( 0.0) 4 ( 1.8) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 11 ( 4.9) 10 ( 4.5) 3 ( 1.3) 2 ( 0.9) 29 ( 9.9) 25 ( 8.9) 6 ( 2.0) 2 ( 0.7) 2 ( 0.9) 1 ( 0.5) 0 ( 0.0) 0 ( 0.0) 6 ( 2.0) 1 ( 0.4) 4 ( 1.4) 1 ( 0.4) Herpes zoster c d Sepsis* c d @ Gastrointestinal disorders Diarrhea 122 ( 54.5) 83 ( 37.6) 22 ( 9.8) 17 ( 7.7) 114 ( 38.9) 34 ( 12.1) 7 ( 2.4) 0 ( 0.0) Nausea e 33 ( 14.7) 22 ( 10.0) 16 ( 7.1) 10 ( 4.5) 31 ( 10.6) 28 ( 10.0) 0 ( 0.0) 0 ( 0.0) Vomiting 17 ( 7.6) 12 ( 5.4) 8 ( 3.6) 5 ( 2.3) 16 ( 5.5) 15 ( 5.4) 1 ( 0.3) 0 ( 0.0) Constipation e 12 ( 5.4) 8 ( 3.6) 0 ( 0.0) 0 ( 0.0) 37 ( 12.6) 25 ( 8.9) 2 ( 0.7) 0 ( 0.0) Abdominal pain e 8 ( 3.6) 7 ( 3.2) 1 ( 0.4) 4 ( 1.8) 31 ( 10.6) 15 ( 5.4) 1 ( 0.3) 1 ( 0.4) Abdominal pain upper e 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 0 ( 0.0) 20 ( 6.8) 12 ( 4.3) 1 ( 0.3) 0 ( 0.0) General disorders and administration site conditions Asthenia 0 ( 0.0) 1 ( 0.5) 0 ( 0.0) 0 ( 0.0) 87 ( 29.7) 53 ( 18.9) 10 ( 3.4) 2 ( 0.7) Fatigue 51 ( 22.8) 30 ( 13.6) 21 ( 9.4) 9 ( 4.1) 31 ( 10.6) 15 ( 5.4) 3 ( 1.0) 0 ( 0.0) Pyrexia e