POS0903 CLINICAL AND RADIOLOGICAL MANIFESTATIONS OF COXITIS IN PATIENTS WITH ANKYLOSING SPONDYLITIS (AS) TREATED WITH TNF-ALPHA INHIBITOR GOLIMUMAB: RESULTS OF A 24-MONTHS OBSERVATION (GO-COX STUDY)
Authors: S. Erdes, E. Agafonova, D. Rumiantceva, S. Davidian, E. Zemerova, A. Kulikov, O. Markova, E. Lukyanova, V. Achikyan
Journal: Annals of the Rheumatic Diseases (2021)

Background: Coxitis (hip joint inflammation) in AS is associated with worse BASFI scores due to hip joint involvement and more severe axial disease [1]. Radiological index of BASRI-hip, US and MRI findings may be used for evaluation of hip joint impairment [2, 3, 4]. Number of studies on coxitis in AS patients treated with biologics was limited at time of this study initiation. Objectives: To evaluate clinical changes measured by BASFI, BASMI, BASDAI, ASDAS-CRP and radiological changes in AS patients with coxitis (BASRI-hip, hip MRI [STIR- and T1-weighted sequences], hip US) after 12 and 24 months of treatment with TNF alpha inhibitor golimumab from baseline. Methods: A non-interventional prospective cohort study. Bio-naïve patients with AS and coxitis were treated with golimumab according to daily clinical practice in 5 clinics across Russia and followed up for 24 months. 39 patients participated. This analysis includes data from 30 patients who completed the follow up. The whole cohort’s data to be presented after consolidation of safety data. MRI and US data were collected for 12 months in up to 28 of 30 patients. The primary endpoint was mean change of BASFI which was expected to be -2.5 (± 2.12) from baseline at week 52 weeks (12 months) of therapy [5]. The power of the study was 90% with minimum sample size of 18 patients. Student’s paired t-criteria, Wilcoxon signed rank test were used to compare quantitave and Chi-square test for qualitative variables. Results: Majority of participants (66,7%; 20 out of 30) were male, with mean (SD) age of 33.2 (9.4) years, mean (SD) duration of AS was 36.2 (42.1) months, mean (SD) duration of coxitis was 36.9 (44.1) months. Baseline mean (SD) scores were: BASFI 3.9 (2.5), BASMI 3.1 (2.5), BASDAI 4.9 (2.0), ASDAS-CRP 3.5 (1.2). Changes of mean clinical scores from baseline after 12 and 24 months of treatment with golimumab were: ΔBASFI= -2.2 (p=0.0001), -2.1 (p=0.0000); ΔBASMI= -1.5 (p=0.0000), -1,8 (p=0.0000); ΔBASDAI= -3.0 (p=0.0000), -3.1 (p=0.0000); ΔASDAS-CRP= -2.0 (p=0.0000), -2.1 (p=0.0000), correspondingly (n=30). The clinical results (medians, interquartile ranges, min and max) are presented below. Baseline mean (SD)/median BASRI-hip was 1.1 (0.8)/1.0 on the right and on the left. Changes of mean/median BASRI-hip score at 12 and 24 months compared to baseline were: 0.3/0.0 (n=25; p=0.2344) and 0.3/0.0 (n=25; p=0.1368) on the right; 0.4/0.0 (n=25; p=0.0352) and 0.4/1.0 (n=25; p=0.0735) on the left. Rates of patients with MRI and US findings are presented below. Hip MRI, paired analysis Patients (%), n=27 Patients (%), n=23 Baseline At 6 months Baseline At 12 months Right No findings 33.3 48.1 39.1 56.5 Subchondral bone marrow edema (SBME) 37.0 11.1 34.8 8.7 Joint effusion 74.1 25.9* 73.9 17.4* Enthesitis 33.3 11.1 34.8 21.7 Fatty degeneration 37.0 55.6 34.8 52.2 Left No findings 29.6 51.9 30.4 52.2 SBME 18.5 3.7 8.7 4.3 Joint effusion 63.0 22.2* 60.9 21.7 Enthesitis 22.2 18.5 17.4 21.7 Fatty degeneration 33.3 55.6 30.4 52.2 Hip US, paired analysis Patients (%), n=28 Patients (%), n=27 Baseline At 6 months Baseline At 12 months Right No findings 14.3 50.0* 18.5 51.9* Joint effusion 46.4 25.0 51.9 11.1* Enthesitis 25.0 14.3 18.5 14.8 Left No findings 14.3 50.0* 18.5 55.6* Joint effusion 42.9 28.6 48.1 25.9 Enthesitis 17.9 17.9 11.1 18.5 * p &lt;0.05 Conclusion: Therapy with TNF alpha inhibitor golimumab for 24 months in AS patients with coxitis was accompanied with statistically significant improvement of clinical scores with primary endpoint achieved (mean BASFI change -2.5 at 12 months), improvement of MRI and US findings without obvious structural progression measured with BASRI-hip score compared to baseline. References: [1]Cruyssen B.V. et al. Rheumatology 2010; 49: 73-81. [2]Boonen A. et al. J Rheumatol 2009; 36; 1249-1255. [3]Cruyssen B.V. et al. Curr Opin Rheumatol 2013, 25: 448-454. [4]Zhen-Guo H. et al. European Journal of Radiology 82 (2013) 1487-1493. [5]Konsta et al. Clin Rheumatol (2013) 32:1229-1232.Braun J. et al. Ann Rheum Dis 2012; 71: 661–667. Disclosure of Interests: Shandor Erdes Speakers bureau: Paid as a speaker during educational activities supported by pharmaceutical companies (MSD, Pfizer, AbbVie, BIOCAD), Ekaterina Agafonova Speakers bureau: Paid as a speaker during educational activities supported by pharmaceutical companies (MSD)., Daria Rumiantceva Speakers bureau: Paid as a speaker during educational activities supported by pharmaceutical companies (Novartis), Satenik Davidian: None declared, Elena Zemerova Speakers bureau: Paid as a speaker during educational activities supported by pharmaceutical companies (MSD, Pfizer), Aleksey Kulikov Speakers bureau: Paid as a speaker during educational activities supported by pharmaceutical companies (MSD, AbbVie, UCB, BIOCAD, Novartis, Sanofi), Olga Markova Speakers bureau: Paid as a speaker during educational activities supported by pharmaceutical companies (MSD, Novartis, Medac, GSK), Ekaterina Lukyanova Employee of: MSD Pharmaceutical LLC (Russia), Director of Medical Affairs., Vladimir Achikyan Employee of: MSD Pharmaceutical LLC (Russia), Therapeutic Area Lead