Effectiveness and Safety of Abatacept in Moderate to Severe Rheumatoid Arthritis

Abstract

Purpose: Abatacept was approved in our hospital by the Pharmacy and Therapeutics Committee for treatment of moderate to severe rheumatoid arthritis (RA) in adult patients with inadequate response or intolerance to disease modifying antirheumatic drugs (DMARDs), including at least one anti-tumour necrosis factor (anti-TNF). The objectives of this study were to analyze compliance with our protocol and to evaluate effectiveness and safety of abatacept in our patients. Methods: We performed a descriptive longitudinal study of patients with RA treated with abatacept between August 2008 and May 2010 in our day care unit. We reviewed clinical records and recorded the following data: sex, age, weight, year of diagnosis, previous antirheumatic treatments and reasons for withdrawal of anti-TNFs, indication for abatacept, dose and date of administration, Disease Activity Score (DAS28) and adverse events. Effectiveness was evaluated using the European League Against Rheumatism (EULAR) criteria. Results: We recruited 16 patients. Mean follow-up time was 10.4 (SD: 6.1) months. All patients had been previously treated with DMARDs, including at least one anti-TNF, and the mean dose of abatacept was 9.4 (SD: 1.4) mg/kg. During the first 6 months of treatment, 11/16 of patients experienced a decrease in their DAS28 value, but only 5/16 achieved a satisfactory response. Dyspnea was the most frequent adverse event (7/16), followed by fatigue and asthenia (6/16) and dry skin (5/16). Conclusions: The indication for abatacept in our hospital complied with the protocol approved by the Pharmacy and Therapeutics Committee. Only 5/16 of patients achieved a satisfactory response; however, it should be noted that these patients had moderate to severe RA that was refractory to other treatments. Adverse reactions were consistent with those described in the summary of product characteristics. Further studies with larger cohorts are needed to analyze the long-term safety and effectiveness profile in clinical practice.
 
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Orofacial adverse effects of biological agents

“…Oral ulceration is among the possible adverse effects of the IL‐2R antibodies basiliximab and daclizumab; rituximab; and alemtuzumab, which are used for rheumatoid arthritis . Oral ulceration has been reported to be a common adverse effect of abatacept …”

Efficacy, safety and tolerability of using abatacept for the treatment of rheumatoid arthritis

“…The disease leads to joint inflammation and destruction and generates a decrease in the health-related quality of life, functional limitations and work disability, mainly due to pain and fatigue (Bagust et al, 2009;Singh et al, 2009;Cortejoso-Fernandez et al, 2012).…”

“…Although RTC have shown the effectiveness of ABT in treating the signs and symptoms of AR, indiscriminate use must be avoided and continued evaluations must be conducted due to the lack of information about the longterm safety (Cortejoso-Fernández et al, 2012). According to a review by Cochrane, ABT presents a better safety profile than most other biologics (Malaviya, Östör, 2012).…”