Low disease activity for up to 3 years after adalimumab discontinuation in patients with early rheumatoid arthritis: 2-year results of the HOPEFUL-3 StudyReport as inadecuate

Low disease activity for up to 3 years after adalimumab discontinuation in patients with early rheumatoid arthritis: 2-year results of the HOPEFUL-3 Study - Download this document for free, or read online. Document in PDF available to download.

Arthritis Research and Therapy

, 19:56

First Online: 14 March 2017Received: 16 October 2016Accepted: 15 February 2017


BackgroundThis study was conducted to evaluate the feasibility of long-term adalimumab ADA discontinuation after achievement of low disease activity LDA in Japanese patients with early rheumatoid arthritis RA and to identify predictors of LDA maintenance.

MethodsIn the HOPEFUL-1 study, patients received initial therapy with either ADA plus methotrexate MTX; intensive therapy or MTX alone standard therapy for 26 weeks, followed by ADA + MTX for 26 weeks. In the HOPEFUL-2 study, patients received ADA + MTX ADA continuation or MTX alone ADA discontinuation for 52 weeks. HOPEFUL-3 was an observational study that enrolled patients who had completed HOPEFUL-2; these patients were followed for an additional 104 weeks.

ResultsOf the 172 patients enrolled in the HOPEFUL-3 study, 135 ADA continuation, n = 61; ADA discontinuation, n = 74 with 28-joint Disease Activity Score using C-reactive protein DAS28-CRP values at both week 52 start of HOPEFUL-2 and week 208 end of HOPEFUL-3 were included in the effectiveness analysis. At week 208, 58 95.1% of 61 patients and 59 79.7% of 74 patients who continued or discontinued ADA, respectively, had LDA DAS28-CRP <3.2. Initial intensive therapy was associated with a better outcome than standard therapy in terms of change in modified total Sharp score from week 0 to week 208, which was ≤0.5 64% vs. 30%. The incidence of adverse events was significantly lower in the ADA discontinuation group than in the ADA continuation group 9.7% vs. 32.9%; p < 0.001.

ConclusionsApproximately 80% of patients who discontinued ADA for 3 years after achieving LDA with ADA + MTX were still in LDA, with a lower incidence of adverse events than patients who continued ADA.

Trial registrationClinicalTrials.gov identifier: NCT01346501. Registered 29 April 2011.

KeywordsAdalimumab Biological agent Observational study Remission induction Rheumatoid arthritis AbbreviationsACPAAnti-cyclic citrullinated peptide antibody


CRPC-reactive protein

DAS2828-joint Disease Activity Score

EGAEvaluator global assessment

ESRErythrocyte sedimentation rate

HAQ-DIHealth Assessment Questionnaire Disability Index

JSNJoint space narrowing

LDALow disease activity

LOCFLast observation carried forward

MMP-3Matrix metalloproteinase 3

mTSSModified total Sharp score


PGAPatient global assessment

RARheumatoid arthritis

RFRheumatoid factor

SJCSwollen joint count

TNFTumor necrosis factor

VASVisual analogue scale

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Author: Yoshiya Tanaka - Hisashi Yamanaka - Naoki Ishiguro - Nobuyuki Miyasaka - Katsuyoshi Kawana - Junko Kimura - Naoki Agata - T

Source: https://link.springer.com/


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