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

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 efficacy 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.

Keywords: adalimumab, ankylosing spondylitis, efficacy, safety

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Claudiu Popescu, Violeta Bojinca, Daniela Opris and Ruxandra Ionescu

ABSTRACT

Aim. The study aims to assess the potential influences of rheumatoid arthritis (RA) and its specific disease measures on lean body composition phenotypes of female patients.

Methods. The study was cross-sectionally designed to include Caucasian postmenopausal female RA patients and age-matched postmenopausal female controls. All the subjects gave written informed consent and the study was approved by the local ethics committee. Each subject underwent in the same day a clinical examination, laboratory tests, whole body dual X-ray absorptiometry (DXA) composition and physical activity estimation using a self-administered questionnaire. Correlations, differences and predictive power were analyzed with appropriate statistical tests.

Results. The study included 107 RA patients and 104 controls. Compared to the normal subjects, who recorded higher levels of physical activity, the RA patients had significantly lower appendicular lean tissue absolute and relative indices and higher prevalence of sarcopenia. The whole body and appendicular lean tissue indices showed significant negative correlations with measures of disease severity (duration, inflammation, quality of life and radiographic progression), independent of age, levels of physical activity, body mass index and smoking.

Conclusions. The measures of disease activity and severity independently predict lean tissue phenotypes in RA patients, behaving as risk factors for sarcopenia and rheumatoid cachexia. The diagnosis of RA in itself is a significant predictive factor of sarcopenia.

Keywords: rheumatoid arthritis, dual X-ray absorptiometry, sarcopenia, cachexia

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