Withdrawal of Infliximab Therapy in Ankylosing Spondylitis in Persistent Clinical Remission, Results From the REMINEA Study

Results From the REMINEA Study

Mireia Moreno; Jordi Gratacós; Vicenç Torrente-Segarra; Raimon Sanmarti; Rosa Morlà; Caridad Pontes; Maria Llop; Xavier Juanola; REMINEA study Group

Disclosures

Arthritis Res Ther. 2019;21(88)

Conclusion

In summary, this is the first prospective trial performed in a homogeneous cohort of AS patients to evaluate the effect of anti-TNF withdrawal in patients presenting persistent clinical remission. Our data of clinical relapse during the first 12 months in the majority of patients in AS patients are in agreement with the study in non-radiographic axSpA previously published. Moreover, although the reintroduction of infliximab treatment was safe, half of the patients did not achieve the same clinical response as prior to treatment withdrawal.

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Abbreviations
AS: Ankylosing spondylitis; ASAS: Assessment of Spondyloarthritis International Society; AxSpA: Axial spondyloarthritis; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASFI: Bath Ankylosing Spondylitis Functional Index; CRP: C-reactive protein; ESR: Erythrocyte sedimentation rate; IBD: Inflammatory bowel disease; NSAID: Nonsteroidal anti-inflammatory drugs; NY criteria: New York criteria; SD: Standard deviation; SER: Spanish Society of Rheumatology; VAS: Visual analogue scales

Funding
This work is conducted under the umbrella of the Rheumatology Society of Catalonia and supported by Merck Research Laboratories.

Availability of data and materials
For information of availability of data included in REMINEA database, contact Dr. Juanola.

Declarations
We confirm that the article has not been published before and is not under consideration for publication elsewhere, and that it is approved by all the authors mentioned.

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.

Publisher's Note
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Arthritis Res Ther. 2019;21(88) © 2019 BioMed Central, Ltd.
Copyright to this article is held by the author(s), licensee BioMed Central Ltd. This is an Open Access article: verbatim copying and redistribution of this article are permitted in all media for any purpose, provided this notice is preserved along with the article's original citation.

Table 1. Baseline characteristics of the cohort of 107 patients who started infliximab treatment
	Number of valid values	Baseline characteristics
Age (years), mean ± SD	104	41.8 ± 12.0
Disease duration (years)^†, mean ± SD male sex, n(%) HLA-B27 positive, n (%)	91,107 77	11.9 ± 10.4 75 (70.1%) 69 (89.6%)
Modified Schober test (cm), mean ± SD	87	3.7 ± 1.9
Fingertip to floor distance (cm), mean ± SD	101	19.6 ± 13.9
Number of swollen joints, mean ± SD	107	1.13 ± 2.2
CRP (mg/dl), mean ± SD	103	2.23 ± 2.82
ESR (mm/h), mean ± SD	105	35.3 ± 28.0
VAS nocturnal spinal pain (cm), mean ± SD	99	5.7 ± 2.8
VAS spinal pain(cm), mean ± SD	98	6.3 ± 2.4
VAS patient global (cm), mean ± SD	99	7.2 ± 1.8
BASDAI score (cm), mean ± SD	102	6.2 ± 1.9
BASFI score (cm), mean ± SD	100	4.9 ± 2.7

n number, SD standard deviation, CRP C-reactive protein, ESR erythrocyte sedimentation rate, VAS patient's rating of pain by visual analogue scale ranging from 0 (none) to 10 (worst), BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index
^†50% of patients had less than 10 years of disease duration

Table 2. Comparison of significant variables between patients on infliximab according to remission status and patients after infliximab withdrawal according to the absence of clinical relapse
	Infliximab treatment			Infliximab withdrawal
	Clinical persistent remission* (n = 36)	No remission (n = 71)	P value	Clinical relapse** (n = 21)	Free of clinical relapse (n = 12)	P value
Age (years), mean ± SD	38.52 ± 11.96	3.39 ± 11.81	0.05	40 ± 12	37 ± 12	ns
Disease duration (years)†, mean ± SD	8.94 ± 8.09	13.69 ± 11.29	0.02	9 ± 8.0	9 ± 9.0	ns
CRP (mg/dl), mean ± SD	3.41 ± 3.65	1.63 ± 2.10	0.01	3.9 ± 3.5	3.0 ± 3.1	ns
BASDAI score (cm), mean ± SD	5.95 ± 1.85	6.4 ± 1.82	ns	6 ± 2.0	6 ± 2.0	ns
BASFI score (cm), mean ± SD	4.35 ± 2.44	5.18 ± 2.81	ns	4 ± 3.0	5 ± 2.0	ns

SD standard deviation, CRP C-reactive protein, BASDAI Bath Ankylosing Spondylitis Disease Activity Index, BASFI Bath Ankylosing Spondylitis Functional Index
*Clinical persistent remission: BASDAI ≤ 2 and normal C-protein reactive (CRP) and the absence of active arthritis and/or enthesitis and/or any otherextra-articular manifestation during the last 6 months in the absence of any additional steroid and/or NSAID treatment, refers to patients under IFX treatment
**Relapse: any time period as newly appearing BASDAI ≥ 4 and/or CRP ≥ 0.8 mg/dl after treatment with IFX withdrawal
^†50% of patients had less than 10 years of disease duration