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Dose de‐escalation to adalimumab 40 mg every 3 weeks in patients with Crohn's disease – a nested case–control study
Author(s) -
Van Steenbergen S.,
Bian S.,
Vermeire S.,
Van Assche G.,
Gils A.,
Ferrante M.
Publication year - 2017
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/apt.13964
Subject(s) - medicine , adalimumab , adverse effect , crohn's disease , gastroenterology , odds ratio , surgery , disease
Summary Background Data on dose de‐escalation in patients with Crohn's disease (CD) are limited. Aim To evaluate outcomes of dose de‐escalation from adalimumab (ADM) every other week (EOW) to every three weeks (ETW). Methods We selected patients with CD receiving maintenance therapy with ADM 40 mg ETW with serum levels (SL) available before and after dose de‐escalation. Sex‐ and age‐matched controls continuing ADM 40 mg EOW were identified. Patient reported outcome, C‐reactive protein (CRP) and serum albumin were collected. Results Out of 898 patients, we identified 40 (11 male, median 37 years) who de‐escalated to ADM 40 mg ETW for ADM‐related adverse events (AE, n = 1), ADM SL >7 μg/mL ( n = 8), or both ( n = 31). Compared to controls, ADM SL dropped significantly within 4 months, without associated clinical or biochemical changes. In 53% of patients, dose de‐escalation was associated with disappearance of AE (8/16 skin manifestation, 3/6 arthralgia, 5/7 frequent infectious episodes). During a median follow‐up of 24 months, 65% of patients maintained clinical response, but 35% needed dose escalation back to ADM 40 mg EOW because of clinical relapse ( n = 8), ADM SL <4 μg/mL ( n = 2), or both ( n = 4). CRP <3.5 mg/L at dose de‐escalation was independently associated with dose escalation‐free survival [odds ratio 6.28 (95% CI 1.83–21.59), P = 0.004]. We could not define a minimal ADM SL to consider or maintain dose de‐escalation. Conclusions Overall, 65% of patients who de‐escalated to adalimumab 40 mg every 3 weeks remained in clinical remission for a median of 24 months. In 53% of patients, adalimumab‐related adverse events disappeared after dose de‐escalation. Regardless of adalimumab SL, disease remission should be assessed objectively prior to dose de‐escalation.