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Observational Study
. 2019 Apr 5;21(1):88.
doi: 10.1186/s13075-019-1873-3.

Withdrawal of infliximab therapy in ankylosing spondylitis in persistent clinical remission, results from the REMINEA study

Mireia Moreno  1 , Jordi Gratacós  2 , Vicenç Torrente-Segarra  3 , Raimon Sanmarti  4 , Rosa Morlà  5 , Caridad Pontes  6 , Maria Llop  1 , Xavier Juanola  7 ; REMINEA study Group
Collaborators, Affiliations
Observational Study

Withdrawal of infliximab therapy in ankylosing spondylitis in persistent clinical remission, results from the REMINEA study

Mireia Moreno et al. Arthritis Res Ther. .

Abstract

Background: Recent data suggest that anti-TNF doses can be reduced in ankylosing spondylitis (AS) patients. Some authors even propose withdrawing treatment in patients in clinical remission; however, at present there is no evidence to support this.

Objective: To assess how long AS patients with persistent clinical remission remained free of flares after anti-TNF withdrawal and to evaluate the effects of treatment reintroduction. We also analyze the characteristics of patients who did not present clinical relapse.

Methods: Multicenter, prospective, observational study of a cohort of patients with active AS who had received infliximab as a first anti-TNF treatment and who presented persistent remission (more than 6 months). We recorded at baseline and every 6-8 weeks over the 12-month period the age, gender, disease duration, peripheral arthritis or enthesitis, HLA-B27 status, BASDAI, CRP, ESR, BASFI, and three visual analogue scales, spine global pain, spinal night time pain, and patient's global assessment.

Results: Thirty-six out of 107 patients (34%) presented persistent remission and were included in our study. After treatment withdrawal, 21 of these 36 patients (58%) presented clinical relapse during follow-up. Infliximab therapy was reintroduced and only 52% achieved clinical remission, as they had before the discontinuation of infliximab; in an additional 10%, reintroduction of infliximab was ineffective, obliging us to change the anti-TNF therapy. No clinical or biological factors were associated with the occurrence of relapse during the follow-up.

Conclusions: Two thirds of patients in clinical remission presented clinical relapse shortly after infliximab withdrawal. Although the reintroduction of infliximab treatment was safe, half of the patients did not present the same clinical response that they had achieved prior to treatment withdrawal.

Keywords: Ankylosing spondylitis; Anti-TNF therapy; Disease activity; Treatment withdrawal.

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Conflict of interest statement

Ethics approval and consent to participate

All patients included signed an informed consent to participate in REMINEA and the project was approved by ethical committee of all participant hospitals.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the patient outcomes included in the REMINEA study. Clinical persistent remission: BASDAI ≤ 2 and normal C-protein reactive (CRP) and the absence of active arthritis and/or enthesitis and/or any other extra-articular manifestation during the last 6 months in the absence of any additional steroid and/or NSAID treatment. Relapse: any time period as newly appearing BASDAI ≥ 4 and/or CRP ≥ 0.8 mg/dl. Good clinical response: BASDAI< 4 and/or CRP < 0.8 mg/dl. Asterisk indicates 3 patients in the study phase of 12 months of follow-up were lost to follow-up
See this image and copyright information in PMC

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