Adalimumab, Etanercept, Infliximab and Golimumab for the Treatment of Ankylosing Spondylitis and Reactive Arthritis

PICHON RIVIERE, A.; AUGUSTOVSKI, F.; GARCIA MARTI, S.; GLUJOVSKY, D.; ALCARAZ, A.; LOPEZ, A; BARDACH, A.; CIAPPONI, A; MENGARELLI C

Documento de Evaluación de Tecnologías Sanitarias

IECS

Año: 2013 p. 1 - 30

1668-2793

Ankylosing Spondylitis (AS) is the most common and characteristic disease of the spondyloarthropathy class. Its etiology is unknown and it affects the axial skeleton (sacroiliac joints and spine) and ligaments. Up to 30 % of the patients may progress to ankylosis. The published incidence varies between 0.3 and 7.3 cases/100,000 people/year. Reactive arthritis (RA) is a non septic arthritis associated with an extraarticular infection whose most common cause is a Chlamydia Trachomatis infection in 4-15% of the cases. The treatment goal for both conditions is to decrease the extent of inflammation to preserve the performance status using NSAIDs and, in non responders, disease modifying drugs (DMDs) such as sulfasalazine and methotrexate. The use of anti-TNF-alpha drugs for patients refractory to prior regimens has been proposed for AS and RA. Technology The tumor necrosis factor-alpha (TNF-alpha) has inflammatory activity and is exacerbated in spondyloarthropathies. The anti-TNF-alpha is a recombinant human immunoglobulin which inhibits its performance status, therefore the inflammatory activity and tissue damage decrease. Etarnercept is administered twice weekly; Adalimumab, weekly and Golimumab, monthly; the three of them are subcutaneously administered. Infliximab is administered intravenously with additional doses on the second and sixth week and then every eight weeks. Purpose To assess the available evidence on the efficacy, safety and coverage related issues on the use of Etarnercept, Adalimumab, Infliximab and Golimumab in patients with ankylosing spondylitis and reactive arthritis. Methods A bibliographic search was carried out on the main databases: DARE, NHS EED, on Internet general search engines, in health technology evaluation agencies and health sponsors. Priority was given to the inclusion of systematic reviews; controlled, randomized clinical trials (RCTs); health technology assessments and economic evaluations; clinical practice guidelines and coverage policies of other health systems. Results Ankylosing Spondylitis: Two systematic reviews and four RCTs were included. One RCT compared Etanercept (n=379) with Sulfasalazine (n=187), and showed a 76% improvement for Etanercept vs. 53% for Sulfasalazine (p=0.0001) at Week 16 in the joint motion assessment and overall physical activity using ASAS 20 criteria. At one year follow-up, no structural radiological changes were observed in the joints. One RCT including 279 patients showed that 61.2% of the Infliximab-treated patients responded with ASAS 20 criteria at 24 weeks vs. 19.2% in the placebo group (p