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AB0389 Evaluation of Serum Level of Golimumab and Antibodies Anti-Golimumab in Patients with Rheumatic Diseases: Results from A Local Registry
  1. J. Rosas1,
  2. F. Llinares-Tello2,
  3. S. Martín3,
  4. J.M. Senabre1,
  5. E. Salas1,
  6. S. Oliver3,
  7. G. Santos Soler1,
  8. C. Santos Ramírez4,
  9. X. Barber5,
  10. A. Pons1,
  11. C. Cano1,
  12. M. Lorente1
  13. on behalf of AIRE-MB Group
  1. 1Rheumatology Dept.
  2. 2Laboratory Department, Hospital Marina Baixa, Villajoyosa (Alicante)
  3. 3Proteomika, S.L., Derio (Vizcaya)
  4. 4Rheumatology Dept., Hospital Marina Alta, Denia (Alicante)
  5. 5CIO, Universidad Miguel Hernández, Elche (Alicante), Spain

Abstract

Objectives To assess the clinical relevance of serum levels of Golimumab (GLM) and the prevalence of antibodies anti-Golimumab (anti-GLM-Ab), in patients with rheumatic diseases.

Methods We included 49 test of serum level of GLM and anti-GLM-Ab in 27 consecutives patients, on treatment with GLM at least 6 months, diagnosed of rheumatoid arthritis (RA), peripheral psoriatic arthritis (PsA) (18 test in 9 patients), or ankylosing spondylitis (AS) (31 test in 18 patients). Clinical characteristics, clinical activity index (DAS in 28 joints or SDAI, for RA and PsA; BASFI, BASDAI for AS, were recorded.

Serum levels of GLM and anti-GLM-Ab was evaluated by a new ELISA kit developing: Promonitor®-GLM y Promonitor®-anti-GLM-Ab (Proteomika, Derio. Vizcaya. Spain). Cut-off level for serum level of GLM was >32 ng/mL and for anti-GLM-Ab was >20 UA/mL. Serum samples were collected before injection of GLM, and stored frozen -80°C, until analysis.

Results We enrolled 27 patients, 56% were women; mean age 50±12 years. The diagnosis of patients was: RA/PsA in 33% (37% of total test) and AS in 67% (63% of tests). The average time of treatment for the whole population was 14±13 years; but lower in AR/PsA patients respect to AS patients (9.5 vs 17 years; p=0.08). In patients with RA/PsA, the mean DAS28 and SDAI was 2.03±1 and 4.2±5.8 respectively; in AS patients the mean BASDAI and ASDAS was 6.7 and 3.5, respectively.

The mean time on treatment with GLM was 12±9 months (range: 1-28). 65% of patients was treated with some DMARD (100% of patients with RA/PsA) and 65% have treated before with some anti-TNF drugs: adalimumab: 40%, etanercept: 35%, infliximab: 25% (1 anti-TNF: 18%; 2 anti-TNF: 31%; 3 anti-TNF: 16%).

The mean serum level of GLM was 1.006 ng/mL (RA/PsA: 889 ng/mL vs AS: 986 ng/mL). Three (11%) patients had developed anti-TNF antibodies previously: 2 patients against infliximab and 1 patient against adalimumab.

One patient with AS on GLM treatment as the third anti-TNF (adalimumab and etanercept), and with previously ant-adalimumab antibodies, developed anti-GLM-Ab (773 UA/mL), in the sixth month of treatment, losing efficacy (prevalence of anti-GLM-Ab in the total patients: 4%).

In the group of patients who had been developed anti-adalimumab antibodies, 20% of them developed anti-GLM-Ab.

Conclusions 1. Immunogenicity induced by GLM is scarce. The prevalence of anti-GLM-Ab was of 4% of patients in this study. 2. In 20% of patients with previous anti-adalimumab antibodies, developed anti-GLM-Ab.

Disclosure of Interest None declared

DOI 10.1136/annrheumdis-2014-eular.3862

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