Abstract
Consistent with previous studies in patients (pts) with inflammatory bowel disease (IBD) and the general population, analyses from the tofacitinib OCTAVE UC clinical program demonstrated that older age was associated with poorer health outcomes in pts with UC.1 To further understand the relationship between age and risk/benefit of tofacitinib, this post hoc analysis assessed HRQoL and pt-reported outcomes (PROs) stratified by age among pts enrolled in the tofacitinib OCTAVE UC clinical program. In OCTAVE Sustain and OCTAVE Open, there was no consistent trend for change from baseline in SFS among age and treatment groups, and similar changes from baseline in RBS were observed across age groups among tofacitinib-treated pts (Table). Change from induction study baseline in Mayo stool frequency and rectal bleeding subscores among patients in the OCTAVE UC clinical program, stratified by age (full analysis set, observed) OCTAVE Induction 1&2a OCTAVE Sustainb OCTAVE Openc Placebo (N=234) Tofacitinib 10 mg BID (N=905) Placebo (N=198) Tofacitinib 5 mg BID (N=198) Tofacitinib 10 mg BID (N=197) Tofacitinib 5 mg BID (N=175) Tofacitinib 10 mg BID (N=769) Change from baseline in Mayo stool frequency subscore, mean (SD) Age category (years) 18 to < 30 –0.5 (0.8) –0.9 (1.1) –2.2 (1.0) –1.8 (1.0) –2.2 (0.7) –2.0 (1.0) –1.9 (1.0) 30 to < 40 –0.5 (0.8) –1.0 (1.0) –1.4 (1.2) –1.4 (1.0) –1.6 (0.8) –1.9 (1.2) –2.2 (0.9) 40 to < 50 –0.7 (0.9) –1.1 (1.1) –1.6 (0.7) –1.7 (0.9) –1.6 (1.0) –1.9 (0.9) –2.4 (0.6) 50 to < 60 –0.6 (1.0) –1.3 (1.0) –1.8 (0.9) –1.9 (1.0) –1.9 (0.7) –2.0 (1.2) –2.0 (0.8) ≥ 60 –0.6 (0.8) –1.1 (1.0) –0.7 (1.1) –2.1 (1.0) –1.5 (1.0) –1.8 (0.8) –2.3 (0.7) Change from baseline in Mayo rectal bleeding subscore, mean (SD) Age category (years) 18 to < 30 –0.8 (0.8) –1.0 (0.9) –1.7 (0.5) –1.5 (0.8) –1.7 (0.6) –1.6 (0.5) –1.6 (0.7) 30 to < 40 –0.6 (0.8) –1.1 (0.9) –1.4 (0.7) –1.3 (0.7) –1.5 (0.7) –1.5 (0.9) –1.7 (0.7) 40 to < 50 –0.7 (0.8) –1.1 (0.9) –1.6 (0.9) –1.4 (0.8) –1.5 (0.7) –1.6 (0.7) –1.7 (0.6) 50 to < 60 –0.7 (0.8) –1.2 (0.8) –1.4 (0.5) –1.6 (0.6) –1.5 (0.5) –1.6 (0.6) –1.5 (0.6) ≥ 60 –0.8 (1.0) –1.2 (0.8) –0.7 (1.1) –1.6 (0.6) –1.4 (0.7) –1.6 (0.6) –1.6 (0.5) a Data are taken from Week 8 of OCTAVE Induction 1&2 bData are taken from Week 52 of OCTAVE Sustain cData are taken from Month 48 of OCTAVE Open BID, twice daily; N, number of patients; OLE, open-label, long-term extension; SD, standard deviation; UC, ulcerative colitis [Figure omitted.