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


Arthritis Res Ther. 2019;21(88) 

In This Article


One hundred and seven patients, 72% male, with a first infliximab prescription, were retrospectively identified. The main characteristics of these patients are shown in (Table 1). Among these patients, 36 (34%) achieved persistent clinical remission and were included in the prospective study, so infliximab treatment was then discontinued. The period of clinical remission before treatment withdrawal ranged in all cases between 6 and 12 months. After treatment withdrawal, only 12 out of these 36 subjects (33.3%) remained free of clinical relapse during the follow-up. Overall, 21 of these 36 patients (58.3%) presented clinical relapse (three patients were lost during the follow-up study). Half of the relapses appeared within 6 months of infliximab withdrawal. In the 21 patients who presented clinical relapse, infliximab therapy was reintroduced and 11 (52%) again achieved clinical remission, but ten (48%) did not. Of these ten patients, in seven, the reintroduction of infliximab was associated with good clinical response (absence of flare, BASDAI < 4 and/or CRP < 0.8 mg/dl), but in three (14%), the treatment was ineffective, and we had to change to another anti-TNF treatment (Figure 1). The reintroduction of infliximab was safe, and no important side effects or infusion reactions were recorded.

Figure 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

Analyzing the retrospective data, we found that age (39 ± 12 vs 43 ± 14 years, p = 0.05), disease duration (9 ± 8 vs 14 ± 11 years, p = 0.02), and CRP at the start of infliximab treatment (3.41 ± 3.65 vs 1.63 ± 2.10, p = 0.02) were associated, in the pre-study period, with clinical remission under infliximab treatment. However, unfortunately, we did not find any statistical differences between any clinical or biological parameter in patients who remained free of clinical relapse during follow-up after treatment withdrawal compared with those who did not (Table 2).