P458. Long-term efficacy and safety of adalumumab in patients with Crohn's disease naïve to prior anti-TNFa therapy compared to prior infliximab failures
K. Papamichael1, E. Archavlis1, P. Konstantopoulos1, N. Kyriakos1, D. Tsironikos1, I. Drougas1, X. Tzanetakou1, I. Internos1, S. Anastasiadis1, P. Karatzas1, G. Mantzaris1, 1Evangelismos Hospital, Athens Greece, A' Department of Gastroenterology, Athens, Greece
The aim of our study was to assess the efficacy and safety of adalimumab (ADA) in anti-TNFa naïve Crohn's disease (CD) patients and IFX failures.
Observational, retrospective, single-centre study that included consecutive patients who received ADA (160/80 mg sc at weeks 0/2 and then 40 mg, eow) who were anti-TNF naïve (Group I) and IFX failures for primary non response (PnNR), adverse events (AE) or loss of response (LoR) (Group II). Using a fixed protocol, CD activity was assessed regularly by CDAI and CRP. Endoscopy was performed at week 28 and thereafter whenever new symptoms recurred. Primary outcomes were long-term efficacy and safety of ADA. Definitions: remission [CDAI <150, normal CRP and complete or near complete (few remaining aphthae) mucosal healing]; response [drop in CDAI >70/>150, CRP >50%, and no mucosal healing]; perianal CD remission (fistula closure); ADA LoR [CDAI >180, abnormal CRP, recurrence of ulcers].
36 patients were included in Group I and 39 in Group II and were followed for 20 (3–50) (median, range) months. Patient data are shown in Table 1. 2/36 patients in Group I vs. 6/39 in Group II were PNR to ADA. ADA dose was escalated in 14/34 (41%) and 26/33 (79%) responders (P = 0.003) in Groups I and II after 15 (6–36) months and 12 (3–60) months (P > 0.05), respectively; as a result 7/14 (50%) patients in Group I vs. 9/26 (34.6%) in Group II regained remission or clinical response (P > 0.05). AE (Table 1) led to ADA discontinuation in 1 patient in Group I and 2 in Group II. At the end of the follow up, 14/34 (41.2%) and 10/34 (29.4%) patients in Group I were in remission or clinical response vs. 5/33 (15.1%) (P = 0.029) and 16/33 (48.4%) (P > 0.05) in Group II. 6/9 (66.6%) and 13/18 (72.2%) patients in Groups I and II had prolonged remission of the perianal disease. 8/34 (23.5%) patients in Group I and 12/33 (36.4%) in Group II stopped therapy after 21 (18–40) months and 12 (9–38) months, respectively (p > 0.05) (Table 1). CD patients who failed ADA therapy were treated mainly with MTX or required surgery.
|Group I (N = 36)||Group II (N = 39)||P|
|Male, n (%)||20 (55.5)||26 (66.6)||NS|
|Age: median (range), (y)||30.5 (18–57)||29 (17–63)||NS|
|Disease location, n (%)|
|Ileitis||15 (41.6)||9 (23.1)||NS|
|Ileocolitis||16 (44.6)||26 (66.7)||NS|
|Colitis||5 (13.8)||4 (10.2)||NS|
|Perianal fistulising disease, n (%)||9 (25)||18 (46.1)||NS|
|Smokers, n (%)||19 (52.7)||16 (41)||NS|
|Extraintestinal manifestations, n (%)||16 (44.6)||20 (51.3)||NS|
|Previous surgery, n (%)||12 (33.3)||21 (53.8)||NS|
|Adverse events, n (%)||4 (11.7)||11 (33.3)||0.043|
|ADA discontinued, n (%)||8 (23.5)||12 (36.4)||NS|
This single center study shows that more anti-TNF naïve CD patients treated with ADA will achieve remission and fewer will need dose intensification or will develop AE compared to patients treated with ADA for IFX failure.