Maintenance of biologic-free remission with naproxen or no treatment in patients with early, active axial spondyloarthritis: results from a 6-month, randomised, open-label follow-up study, INFAST Part 2

Abstract

ObjectiveTo investigate whether biologic-free remission can be achieved in patients with early, active axial spondyloarthritis (SpA) who were in partial remission after 28 weeks of infliximab (IFX)+naproxen (NPX) or placebo (PBO)+NPX treatment and whether treatment with NPX was superior to no treatment to maintain disease control.MethodInfliximab as First-Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial (INFAST) Part 1 was a double-blind, randomised, controlled trial in biologic-naïve patients with early, active, moderate-to-severe axial SpA treated with either IFX 5 mg/kg+NPX 1000 mg/d or PBO+NPX 1000 mg/d for 28 weeks. Patients achieving Assessment of SpondyloArthritis international Society (ASAS) partial remission at week 28 continued to Part 2 and were randomised (1:1) to NPX or no treatment until week 52. Treatment group differences in ASAS partial remission and other efficacy variables were assessed through week 52 with Fisher exact tests.ResultsAt week 52, similar percentages of patients in the NPX group (47.5%, 19/40) and the no-treatment group (40.0%, 16/40) maintained partial remission, p=0.65. Median duration of partial remission was 23 weeks in the NPX group and 12.6 weeks in the no-treatment group (p=0.38). Mean Bath Ankylosing Spondylitis Disease Activity Index scores were low at week 28, the start of follow-up treatment (NPX, 0.7; no treatment, 0.6), and remained low at week 52 (NPX, 1.2; no treatment, 1.7).ConclusionsIn axial SpA patients who reached partial remission after treatment with either IFX+NPX or NPX alone, disease activity remained low, and about half of patients remained in remission during 6 months in which NPX was continued or all treatments were stopped.

Cytokines as Therapeutic Targets in Rheumatoid Arthritis and Other Inflammatory Diseases

“…Discontinuation of the anti-TNF therapy in AS generally results in rapid relapse of active disease (reviewed in Baraliakos et al, 2013b, andSong et al, 2013a). This was also the case in early disease, although a recent study in patients with very early disease (mean 1.8 years) reported biologic-free remission/LDA rate of 94% during the 24-week follow up after induction therapy with infliximab and naproxen (Sieper et al, 2014b). It should, however, be noted that the percentage of patients in partial remission decreased steadily over the 6 months of follow up.…”

Efficiency and safety of different etoricoxib regimens in patients with axial spondyloarthritis, including ankylosing spondylitis

“…показали, что длительность болезни менее 3 лет -это прогностически благоприятный при-знак для лечения аксСпА [2,6,7]. Важно, что частичная ремиссия у пациентов без НПВП сохранялась в течение 12 нед (медиана), у пациентов, принимавших НПВП, -до 26 нед [36]. Это представляет несомненный интерес, так как в ходе настоящего исследования осталось неясным, как долго следует продолжать лечение ЭТ пациентам с ча-стичной ремиссией.…”

Unanswered questions in the management of axial spondyloarthritis: an opinion piece

“…However, in patients with early, active axSpA, the INFAST study showed the encouraging result that partial remission could be maintained in almost half of the patients at 6 months after stopping the treatment (infliximab/ placebo+naproxen); improvements in several less-stringent measures of disease activity were generally maintained with very few patients experiencing disease flares [36]. Whether this low level of disease activity could be maintained beyond 6 months has not been studied.…”