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THU0270 European ankylosing spondylitis (AS) infliximab cohort (EASIC) long-term extension: Efficacy and safety of infliximab over a time period of more than 7 years in patients with AS
  1. F. Heldmann1,
  2. X. Baraliakos1,
  3. J. Brandt2,
  4. I. van der Horst-Bruinsma3,
  5. R. Landewé4,
  6. J. Sieper5,
  7. G.R. Burmester6,
  8. F. van den Bosch7,
  9. K. de Vlam8,
  10. H. Gaston9,
  11. M. Grünke10,
  12. T. Appelboom11,
  13. P. Emery12,
  14. M. Dougados13,
  15. M. Leirisalo-Repo14,
  16. M. Breban15,
  17. J. Braun1
  1. 1Rheumatology, Rheumazentrum Ruhrgebiet, Herne
  2. 2Rheumapraxis Steglitz, Berlin, Germany
  3. 3VU Medical Center
  4. 4Dept. of Clinical Immunology and Rheumatology, Academic Medical Center/University of Amsterdam, Amsterdam, Netherlands
  5. 5Charité, Campus Benjamin Franklin
  6. 6Charité, University Medicine, Berlin, Germany
  7. 7Universitair Ziekenhuis, Ghent
  8. 8University Hospital Leuven, Leuven, Belgium
  9. 9University of Cambridge, Cambridge, United Kingdom
  10. 10Klinikum der Universität, Munich, Germany
  11. 11Hopital Erasme, Brussels, Belgium
  12. 12University of Leeds, Leeds, United Kingdom
  13. 13Hopital Cochin, Paris, France
  14. 14University Central Hospital, Helsinki, Finland
  15. 15Hopital Ambroise Paré, Boulogne, France

Abstract

Background The knowledge on the long term efficacy and safety of anti-TNF therapy in patients with AS is rather limited.

Methods 71/81 patients (87.7%) who completed the 2 year (y) EASIC trial (after 2y of ASSERT and 1.3y between trials) were directly included into the EASIC extension for another 96 weeks. 10/81 patients had discontinued for logistic reasons. All patients received infliximab in the same dosage regime as in the EASIC core study (5mg/kg every 6-8 weeks). The patients received a total treatment period of more than 7y. All adverse events (AE), serious adverse events (SAE) and drop-outs were recorded similar to common efficacy indices (BASDAI, BASFI, Enthesitis index, CRP) which were available for 64 completers and 6 patients with premature withdrawal.

Results 64 (90.1%) of patients completed the trial, while 7 did not. 3 were discontinued by the investigator (1 due to loss of response,infections and basal cell carcinoma, respectively), 1 was lost to follow-up and 3 withdrew consent. The mean BASDAI for completers was 2.4 (±1.7) with 49/64 (76.6%) showing BASDAI levels <4, and 42 (65.6%) even showed a BASDAI <3, indicative of low disease activity. Half of the 6 patients with withdrawal showed BASDAI levels >4 at their last visit. The mean CRP for completers (n=61) was 4.9±5.9 mg/l at the last study visit. 81% of patients showed no enthesitis. The mean BASFI of 64 completers was 3.1±2. In the extension 476 AE occurred in 63/71 patients (88.7%), 61 of which (96.8%) had >1 AE. There were 13 SAE during the whole study period. The most common AE were infections (35.1% of all AE): 116 (69.5%) of the respiratory tract, 25 (14.9%) of the skin, 12 (7.2%) of the gastrointestinal and 7 (4.2%) of the urogenital tract. Two malignancies were observed: one basal cell carcinoma of the skin (patient was discontinued), while the other patient refused to discontinue despite a diagnosis of skin melanoma because of the favourable effect of infliximab. These 2 SAE were the only SAE that were judged to be possibly related to infliximab. 5 minor infusion reactions were observed in 5 patients, 3 of whom completed the trial. Other AEs were: 1 herpes zoster, 7 cases of elevated liver enzymes in 6 patients, 36 non-infectious AE of the skin (5 cases of psoriasis), 3 flares of inflammatory bowel disease in 2 patients, 2 episodes of anterior uveitis (1 flare of a patient with recurrent uveitis and one new onset).

Conclusions Treatment with infliximab was efficacious and safe with a favorable benefit-risk ratio for patients with AS for >7 years. The most AE were infections. There were no serious infections or deaths. The 2 cases of skin malignancy are in line with previous study results and reports from other registries.

Disclosure of Interest None Declared

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