Table 1. Baseline characteristics Group C: with IS N=32 Group C: Without IS N=85 P Value Male gender, n (%) 12 (38) 27 (32) 0.6606 Age, years, mean (SD) [min-max] BMI, kg/m2, mean (SD) [min-max] 40 (12) [22-63] 25 (6) [18–41] 37 (11) [19–64] 24 (5) [17–47] 0.3736 Active smoking, n (%) 14 (44) 52 (62)* 0.0949 Crohn’s disease, n (%) 21 (66) 71 (84) 0.0446 Duration of IBD, years, mean (SD) [min-max] Age at IBD, years, mean (SD) [min-max] Harvey-Bradshaw score (Crohn’s disease), mean (SD) [min-max] Mayo score (ulcerative colitis), mean (SD) [min-max] 11 (9) [1–32] 28 (10) [12–58] 3.0 (2.6) [0-8] 1.0 (1.7) [0-5] 10 (7) [0–33} 27 (9) [9–51] 4.9 (4.6) [0-22] 2.9 (2.7) [0-8] 0.7923 At least one 11 (34) 15 (18) 0.0789 2008-2009 8 (26) 11 (13)* 0.1534 2007-2008 8 (26) 12 (14)* 0.1676 2006-2007 4 (13) 11 (13)* 0.9999 All 3 years 3 (10) 8 (9)* 0.9999 0.7902 0.6114 0.1691 0.0546 Influenza vaccination within past 3 years, n (%) Pneumococcal vaccination within past 3 years, n (%) 5 (16) 4 (5) 0.0618 Table 2. Immune response to first-year (2009–2010) influenza vaccine A/H1N1 2007 A/H3N2 B Group A: no IS N=31 Group B: IS without anti-TNF N=77 Group C: anti-TNF with or without IS N=117 Group C: anti-TNF with IS N=32 Group C: anti-TNF without IS N=85 P-value (4 groups) PValue** (C with vs. C without) 3/31 (10) 23/30 (77) 16/29 (55) 10/26 (38) 9/73 (12) 55/73 (75) 38/69 (55) 25/54 (46) 11/116 (9) 75/113 (66) 31/102 (30) 18/89 (20) 4/32 (13) 19/32 (59) 12/30 (40) 7/25 (28) 7/84 (8) 56/81 (69) 19/72 (26) 11/64 (17) 0.8327 0.3555 0.0024 0.0056 0.4926 0.3788 0.2372 0.2572 20/30 (67) 46/72 (64) 60/112 (54) 13/32 (41) 47/80 (59) 0.1216 0.0963 9.2 (31, 6.3–13) 74 (30, 46–119) 7.9 (30, 4.8–13) 9.4 (73, 7.3–12) 73 (73, 52–101) 7.7 (72, 5.5–11) 8.3 (116, 7.1–9.6) 57 (113, 44–73) 6.8 (112, 5.3–8.6) 9.7 (32, 6.9–14) 51 (32, 32–82) 5.3 (32, 3.4–8.1) 7.8 (84, 6.6–9.2) 59 (81, 43–80) 7.5 (80, 3.3–10.1) 0.5939 0.5427 0.5927 0.2183 0.6679 0.2236 5/31 (16) 23/30 (77) 15/29 (52) 12/26 (46) 13/73 (18) 50/73 (68) 31/69 (45) 21/53 (40) 10/115 (9) 59/113 (52) 18/103 (17) 11/88 (13) 6/32 (19) 16/32 (50) 4/30 (13) 3/25 (12) 4/83 (5) 43/81 (53) 14/73 (19) 8/63 (13) 0.0293 0.0350 <0.0001 <0.0001 0.0270 0.8358 0.5773 0.9999 19/30 (63) 36/72 (50) 45/111 (41) 13/32 (41) 32/79 (41) 0.1534 0.9999 GMT (N, 95% CI) D0 D21 Fold increase D21/D0 11 (31, 8–16) 77 (30, 46–127) 6.5 (30, 4.0–11) 13 (73, 10–15) 53 (73, 39–71) 4.1 (72, 3.1–5.4) 10 (115, 9–12) 31 (113, 25–39) 3.2 (111,2.6–3.9) 12 (32, 8–17) 31 (32, 20–47) 2.6 (32,1.7–3.8) 9 (83, 8–11) 32 (81, 25–40) 3.5 (79,2.8–4.3) 0.1822 0.0014 0.0427 0.2386 0.9146 0.2127 Seroprotection, n/N (%) D0 D21 M6 11/31 (35) 29/30 (97) 25/29 (86) 36/73 (49) 69/72 (96) 57/69 (83) 46/115 (40) 108/114 (95) 75/100 (75) 21/32 (66) 31/32 (97) 25/29 (86) 25/83 (30) 77/82 (94) 50/71 (70) 0.0026 0.9650 0.1661 0.0068 0.9999 0.1288 Seroprotection, n/N (%) D0 D21 M6 M12 Seroconversion, n/N (%) D21–D0 GMT (N, 95% CI) D0 D21 Fold increase D21/D0 Seroprotection, n/N (%) D0 D21 M6 M12 Seroconversion, n/N (%) D21–D0 M12 21/26 (81) 43/53 (81) 56/88 (64) 20/24 (83) 36/64 (56) Seroconversion, n/N (%) D21–D0 19/30 (63) 54/71 (76) 68/113 (60) 15/32 (47) 53/81 (65) GMT (N, 95% CI) D0 22 (31, 16–30) 23 (73, 18–29) 24 (115, 20–28) 37 (32, 27–49) 20 (83, 16–25) D21 162 (30, 106–249) 149 (72, 124–178) 115 (114, 99–134) 118 (32, 87–161) 114 (82, 95–137) Fold increase D21/D0 7.0 (30, 4.1–12) 6.5 (71, 5.2–8.1) 5.0 (113, 4.0–6.2) 3.2 (32, 2.3–4.5) 5.9 (81, 4.5–7.8) * In vaccine recipients only (N = 49: 8, 14 and 27 for the three groups, respectively); 12 patients received one dose, 37 received two doses. 0.0076 0.0247 0.0382 0.0887 0.0120 0.1325 0.0290 0.0008 0.8733 0.0216