EFFICACY AND SAFETY OF ADALIMUMAB IN ANKYLOSING SPONDYLITIS: DATA FROM REAL LIFE

Claudiu Popescu,Costin Mitulescu,Ruxandra Ionescu,Denisa Predeteanu,Cristina Coroama

doi:10.37897/rjr.2015.1.7

Abstract

Rationale. Data from controlled trials showed that adalimumab, a humanized anti-TNF monoclonal antibody, is effective and safe in the treatment of ankylosing spondylitis (AS). Objectives. The present study aimed to observe the effi cacy and safety of adalimumab in AS in a real life clinical setting. Methods. The study observed cross-sectionaly and retrospectively the efficacy and safety of adalimumab in all the patients admitted to the Rheumatology Department of “Sfânta Maria” Clinical Hospital between January 2008 and June 2013 who were classified as having AS according to the modified New York criteria. The diagnosis and follow-up of uveitic cases were done in the Ophthalmology Department of the Emergency University Hospital. Results. Within the study time-frame, 79 AS patients met the inclusion criteria: 71 (89.9%) had adalimumab for at least 24 months; 8 (10.1%) switched from adalimumab to another biological, as follows: 3 (3.8%) because of serious adverse events, 3 (3.8%) were primary non-responders and 2 (2.5%) were secondary non-responders. The clinical response was fast: after 3 months of treatment, 59 (83.1%) patients had BASDAI < 4 and 55 (77.5%) patients had BASFI < 4. Regarding safety, the serious adverse effects recorded were: infectious arthritis, pulmonary tuberculosis, pulmonary sarcoidosis. There were no cases of cancer or demyelinating disease during the study frame. Conclusions. Therapy with adalimumab in AS produces a prompt and lasting effect. The efficacy (remission) and safety (adverse events) of adalimumab can be monitored in the real-life clinical setting using BASDAI, BASFI, and routine clinical evaluations. Clinicians may need to expect a slightly higher rate of serious adverse events and rate of treatment discontinuation than those reported by controlled trials.

Highlights

Ankylosing spondylitis (AS) is a chronic inflammatory disease which can involve the axial skeleton, the large peripheral joint, the entheses and several extra-articular sites. [1] Typically ankylosing spondylitis (AS) patients are in their third decade of lifeand present inflammatory chronic back pain, sacroiliitis on imaging and human leukocyte antigen (HLA) B27
All the AS patients included in the study met the following criteria: age above 18 years; Caucasian race; classification of AS according to the modified New York criteria; [21] no overlapping chronic inflammatory disease; anti-tumor necrosis factor α (TNFα) naïve before initiation of adalimumab; active disease, defined as BASDAI > 4 and/ or BASFI > 4, which needed biological therapy according to the physician’s opinion and to the Romanian guide to AS treatment, [22] which is in accordance with the ASAS/EULAR recommendations
(23) The informed consent was presumed from the written informed consent each patient gave for being admitted to a university clinic.The data were collected anonymously and it included for each record: demographics, inflammation (C-reactive protein – C reactive protein (CRP); erythrocyte sedimentation rate – ESR), disease measures (disease duration; peripheral and non-articular involvement; HLA B27 status; BASDAI; [24] (BASFI), [25] treatment variables

Summary

Introduction

Ankylosing spondylitis (AS) is a chronic inflammatory disease which can involve the axial skeleton, the large peripheral joint, the entheses and several extra-articular sites (e.g. uveitis, bowel disease, skin etc.). [1] Typically AS patients are in their third decade of lifeand present inflammatory chronic back pain, sacroiliitis on imaging and human leukocyte antigen (HLA) B27. There are four therapeutic measures which proved effective in AS: for the axial form, physical therapy, non-steroidal anti-inflammatory drugs (NSAIDs) and tumor necrosis factor α (TNFα) inhibitors; for the peripheral form sulfasalazine in addition to the afore mentioned drugs. While physical therapy is mandatory for good functional outcomes, irrespective of medical treatments regimes, [4] NSAIDs are effective for chronic pain and are shown to slow radiographic progression, [5] bearing in mind theirmajor cardiovascular and gastrointestinal side effects. All the approved anti-TNFα agents (adalimumab, etanercept, infliximab, golimumab) seem similar regarding efficacy and safety in AS patients. [6] Due to costs and the lack of long term safety data, anti-TNFα agents are given to selected AS patients, which should be monitored thoroughly. All the approved anti-TNFα agents (adalimumab, etanercept, infliximab, golimumab) seem similar regarding efficacy and safety in AS patients. [6] Due to costs and the lack of long term safety data, anti-TNFα agents are given to selected AS patients, which should be monitored thoroughly. [7] For this purpose, in the clinical setting physicians may use two simple disease indices, BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and BASFI (Bath Ankylosing Spondylitis Functional Index)

Methods

Results

Discussion

Conclusion