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
- J Sieper1,
- J Lenaerts2,
- J Wollenhaupt3,
- M Rudwaleit1,
- V I Mazurov4,
- L Myasoutova5,
- S Park6,
- Y Song7,
- R Yao8,
- D Chitkara8,
- N Vastesaeger9,
- on Behalf of All INFAST Investigators
- 1Medical Department I, Rheumatology, Charité Campus Benjamin Franklin, Berlin, Germany
- 2Department of Rheumatology, REUMA Instituut, Hasselt, Belgium
- 3Klinik für Rheumatologie und klinische Immunologie, Schön-Klinik, Hamburg, Germany
- 4St. Petersburg Medical Academy, St. Petersburg, Russia
- 5Kazan State Medical University, Kazan, Russia
- 6Division of Rheumatology, Department of Internal Medicine, Catholic University of Korea, Seoul, South Korea
- 7Department of Internal Medicine, Seoul National University, Seoul, South Korea
- 8Merck Sharp & Dohme Corp., Kenilworth, New Jersey, USA
- 9Merck Sharp & Dohme Corp., Brussels, Belgium
- Correspondence to Professor Joachim Sieper, Medical Department I, Rheumatology, Charité Campus Benjamin Franklin, Hindenburgdamm 30, Berlin 12200, Germany;
- Accepted 14 April 2013
- Published Online First 5 June 2013
Objective To 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.
Method Infliximab 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.
Results At 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).
Conclusions In 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.
This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/