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) 

In This Article

Methods

We conducted a prospective observational study in 23 hospitals with Rheumatology Services in Catalonia, north-eastern Spain, a region with seven million inhabitants. The study included a cohort of patients with active AS who had received infliximab as a first anti-TNF treatment. The study was authorized by the Ethics Committee of the participating hospitals, and all patients gave informed consent prior to taking part in the study.

Patients were included in the cohort and started infliximab treatment if they were aged 18 or over, had a diagnosis of AS according NY criteria, presented a disease duration longer than 1 year, and fulfilled criteria for anti-TNF treatment according to the Guidelines of the Spanish Society of Rheumatology (SER) (BASDAI ≥ 4, despite treatment with 2 nonsteroidal anti-inflammatory drugs (NSAID) for a minimum of 3 months at full dose) .[12] After the infliximab induction period, all patients who presented persistent clinical remission (BASDAI ≤ 2, normal CRP, and 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) were included in a prospective study of infliximab withdrawal. Patients with any other definitive diagnosis of spondyloarthritis (psoriatic arthritis, inflammatory bowel disease, or reactive arthritis) were excluded, as were those with any concomitant rheumatic disease that might modify the clinical evaluation of the disease activity.

During the study, in accordance with standard clinical practice, we prospectively recorded the following variables at baseline, and every 6–8 weeks over a follow-up period of 12 months: age, gender, disease duration, the presence and number of peripheral arthritis or enthesitis, the presence of HLA-B27, the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), CRP, erythrocyte sedimentation rate (ESR), Bath Ankylosing Spondylitis Functional Index (BASFI), and three visual analogue scales (VAS), spine global pain, spinal night time pain, and patient's global assessment. In the pre-study phase, as a secondary objective, we also retrospectively recorded the data from all the cohort of patients with active AS who had initiated treatment with infliximab.

Clinical relapse was defined in any time period as newly appearing BASDAI ≥ 4 and/or PCR ≥ 0.8 mg/dl. For patients with relapse after treatment withdrawal, infliximab treatment was reintroduced without an induction phase or any previous premedication. At the end, a final visit was performed in all patients included in the study.

Frequencies and percentages were given for subjects who achieved initial remission after infliximab treatment and for subjects who did not present a clinical flare after treatment withdrawal during follow-up. Other parameters including baseline and clinical data during follow-up were described by frequency and percentage, mean and standard deviation (SD), median and 25 and 75 percentiles, and 95% confidence intervals [95%CI], as appropriate. No inferential analysis was conducted.

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