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

Background

Axial spondyloarthritis (axSpA) comprises a group of chronic, immune-mediated inflammatory diseases characterized by the predominance of inflammation in the sacroiliac joints and spine. Involvement of peripheral skeletal sites and extra-articular manifestations, such as uveitis, psoriasis, or inflammatory bowel disease (IBD), may develop during the course of the disease .[1] Ankylosing spondylitis (AS) is the most representative disease in this group; its burden has recently been recognized as severe, frequently leading to invalidity, work loss, and social impairment .[1,2]

The introduction of biological therapy has undoubtedly been an important step forward in improving the quality of life, activity, functionality, metrology, and most extra-articular manifestations in patients with AS and other forms of spondyloarthropathy .[1] Around 60% of patients treated with an anti-TNF achieve a good clinical response; however, according to the Assessment of Spondyloarthritis International Society (ASAS), only 20–30% achieve criteria of clinical partial remission in which the patient is apparently asymptomatic .[3,4]

Data from uncontrolled studies and from clinical practice support the possibility of reducing anti-TNF doses below the normal levels licensed in AS patients with good clinical response, and especially in patients in clinical remission .[5–7] In this sense, a recent consensus paper from the Spanish Society of Rheumatology and the Spanish Society of Hospital Pharmacy [8] stressed the possibility of withdrawing anti-TNF treatment in some patients who maintain good clinical response after intensive reduction of anti-TNF treatment ,[8] but the evidence supporting this recommendation is lacking.

In this sense, previous classic studies have suggested the need to maintain anti-TNF therapy indefinitely, as the withdrawal of this treatment is associated with disease reactivation in around 90% of patients within 12 months, independently of the anti-TNF used or the previous duration of treatment .[9] The factors associated with these reactivations include the high clinical activity at the time of treatment suspension, especially when measured through C-reactive protein (CRP), as well as age and disease duration .[9] However, the heterogeneity of the clinical symptoms of the AS patients included the different drugs and doses of anti-TNF prescribed prior to the withdrawal of the treatment and especially the lack of homogeneous criteria of clinical remission in the different studies published all mean that the issue remains highly controversial.

More recently, data from a multicenter, randomized, double-blind study in patients with non-radiographic axSpA, who initially achieved sustained remission, showed that continued therapy with adalimumab was associated with a significant maintenance of remission compared with treatment withdrawal .[10]

Since anti-TNF treatment also presents drawbacks, such as its high cost and the possibility of long-term side effects, it seems reasonable to plan a time-limited treatment for some patients. The aim of our study was to analyze the consequences of the clinical decision to withdraw anti-TNF treatment in a very homogeneous group of AS patients. In this study, we included only data from AS patients who received infliximab as a first anti-TNF treatment and who presented persistent clinical remission (at least 6 months) in accordance with our pre-established definition .[11] The focus of the study was to assess how long patients maintained a good clinical response defined as the absence of flare after anti-TNF withdrawal, and to define the characteristics of patients who did not present clinical relapse.

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