S0648 Clinically Adjusted vs Therapeutic Drug Monitoring Dosing Regimens With Adalimumab in Patients With Moderately to Severely Active Crohn's Disease: Results From the SERENE-CD Maintenance Study

INTRODUCTION: Adalimumab (ADA) is well-tolerated and effective in patients (pts) with Crohn's disease (CD).1,2 The Serene-CD phase 3 study evaluated higher vs standard dosing regimens of ADA 12-week (Wk) induction and 44Wk maintenance therapy in adults with moderate to severe CD. Outcomes of ADA maintenance therapy using clinically adjusted (CA) dosing or therapeutic drug monitoring (TDM) were explored. METHODS: Safety and efficacy of CA and TDM maintenance regimens at Wk56 were assessed. Clinical responders (N = 184) completing Induction were re-randomized at Wk12 and assigned 1:1 to CA or TDM, both arms initially receiving 40 mg ADA every other wk (EOW). The CA arm could escalate to every wk (EW) based on CDAI (≥220) or high-sensitivity C reactive protein (hs-CRP, ≥10 mg/L). The TDM arm could escalate to EW at Wks 14, 28, or 42 if ADA serum concentration was < 5 µg/mL or 5–10 µg/mL with CDAI≥220 or hs-CRP≥10 mg/L. Once escalated, the pt remained at 40 mg EW. Key exploratory efficacy endpoints at Wk56 included clinical remission and endoscopic response and remission (Table 1). Safety was analyzed in pts receiving at least 1 dose of maintenance study drug. RESULTS: Of re-randomized pts, 76 (82.6%) CA and 79 (85.9%) TDM completed the study. BL characteristics/demographics were well-balanced between treatment arms. In CA and TDM arms, 26 (28.2%) and 36 (39.1%) pts escalated to EW dosing, respectively, with most in both groups escalating at Wk14 (13/26 CA, 21/36 TDM). No difference in proportion of pts achieving Wk56 clinical remission, steroid-free clinical remission among subjects taking corticosteroid at Induction BL, endoscopic response, endoscopic remission, or deep remission between CA vs TDM (Table 1) was found. No significant differences observed between the two groups for sustained clinical remission among Wk12 clinical remitters, or for maintenance of endoscopic response and remission among Wk12 responders and remitters respectively (Table 1). Dose escalation was driven by hs-CRP in CA arm and by serum drug levels in TDM arm. Observed safety profile was similar between groups; no new safety signals or unexpected trends were identified. CONCLUSION: Key efficacy endpoints indicate both CA and TDM maintenance regimens are similar as observed in the SERENE-CD maintenance study. Both dosing regimens were well-tolerated with a similar safety profile.3 TDM used for dose adjustment showed no clinical benefit over use of clinical symptoms and biomarkers alone.Table 1

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