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Rheumatology (Oxford). 2016 Nov;55(11):1946-1953. Epub 2016 Jul 13.

Partial remission in ankylosing spondylitis and non-radiographic axial spondyloarthritis in treatment with infliximab plus naproxen or naproxen alone: associations between partial remission and baseline disease characteristics.

Author information

1
Department of Gastroenterology, Infectiology, and Rheumatology, Charité, University Medicine Berlin, Berlin, Germany joachim.sieper@charite.de.
2
Department of Gastroenterology, Infectiology, and Rheumatology, Charité, University Medicine Berlin, Berlin, Germany.
3
Department of Rheumatology, REUMA Instituut, Hasselt, Belgium.
4
Department Rheumatology and Clinical Immunology, Schön-Klinik, Hamburg, Germany.
5
Department of Rheumatology, Kazan State Medical University, Kazan, Russia.
6
Division of Rheumatology, Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University of Korea.
7
Division of Rheumatology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea.
8
Division of Rheumatology, Department of Internal Medicine.
9
Department of Biostatistics, Merck & Co, Kenilworth, NJ, USA.
10
Department of Immunology, MSD Italy, Global Medical Affairs, Rome, Italy.
11
Department of Clinical Research, Merck & Co, Kenilworth, NJ, USA.
12
Department of Medical Affairs, MSD Belgium, Brussels, Belgium.

Abstract

OBJECTIVES:

To evaluate partial remission during treatment with infliximab (IFX) + naproxen (NPX) vs NPX alone in patients from the two subgroups of SpA and explore baseline predictors of partial remission.

METHODS:

Infliximab as First Line Therapy in Patients with Early Active Axial Spondyloarthritis Trial was a double-blind, randomised controlled trial of IFX in biologic-naïve patients with early, active axial SpA. Patients were randomised (2:1) to receive 28 weeks of treatment with i.v. IFX 5 mg/kg (weeks 0, 2, 6, 12, 18 and 24) + NPX 1000 mg/day or i.v. placebo (PBO) + NPX 1000 mg/day. The current post hoc analysis evaluated outcomes in patients who did or did not meet modified New York radiographic criteria for AS.

RESULTS:

The analysis included 94 patients who met AS criteria and 56 with non-radiographic axial SpA (nr-axSpA). At week 28, Assessment of SpondyloArthritis international Society (ASAS) partial remission was greater with IFX + NPX than PBO + NPX for both the AS group (70.5 vs 33.3%, respectively) and the nr-axSpA group (50.0 vs 37.5%, respectively). A similar pattern occurred with several efficacy measures. Larger treatment effects occurred in the AS group than the nr-axSpA group, possibly due to baseline differences in disease characteristics. Multivariable analyses identified the type of treatment, age and HLA-B27 status as predictors of ASAS partial remission in the total study population. MRI sacroiliac joint scores were associated with partial remission during IFX + NPX treatment.

CONCLUSION:

Patients with AS had greater partial remission with IFX + NSAID than NSAID therapy alone; patients with nr-axSpA had a smaller treatment effect. Baseline disease characteristics and age were associated with partial remission with IFX therapy.

KEYWORDS:

ankylosing spondylitis; axial spondyloarthritis; biological products; early disease; infliximab; remission induction; treatment outcome; tumour necrosis factor α

PMID:
27411482
DOI:
10.1093/rheumatology/kew230
[Indexed for MEDLINE]

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