LAUSR

Background Golimumab (GLM) has demonstrated efficacy in RA, PsA, and AS in several randomized clinical trials with biologic-naïve patients. Data from real world practice comparing biologic naïve and experienced patients are lacking. Objectives The aim of this post hoc analysis is to assess effectiveness of GLM used as first, second, or at least third biologic agent in RA, PsA and AS in a real-life setting. Methods Post hoc analysis of the non-interventional, prospective, 24-month GO-NICE study with RA, PsA and AS patients (pts.) starting GLM 50mg SC once monthly in a real practice setting in Germany, details were shown earlier (1,2). Endpoint measures DAS28-ESR, PsARC, and BASDAI are shown as observed. Results In 1458 pts. with RA, PsA or AS GLM was administered as first (n=305, 286, 292, resp.), second (n=104, 136, 130 resp.), or at least third biologic agent (n=64, 79, 58 resp.). Biologic argents in previous treatments included Adalimumab (348), Etanercept (287), Infliximab (139), Tocilizumab (27), Rituximab (15), Certolizumab (14), or Abatacept (n=12). 43.0, 30.8, 39.1% of pts. with RA, 53.1, 38.2, 34.2% with PsA, and 53.8, 49.2, 41.4% with AS completed the study until month 24. RA pts (n=473) RF was positive in 76.9%, 70.2%, and 59.4%, ACPA + in 76.2%, 78.4%, 59.0%, and disease duration was 9.7, 10.1, 14.3 years, in pts. with GLM use as 1st, 2nd, at least 3rd line respectively. DAS28 score at BL was 5.0, 4.9, 5.1 in first, second, and at least third line use of GLM, respectively and dropped significantly in all groups (table). After 3 months of treatment 27.5%, 19.5%, 14.5% of pts. were in remission (<2.6), after 24 months 45.3%, 50.0% or 33.3%, respectively. PsA pts (n=501) Disease duration was 12.4, 13.7, 13.8 yrs, in pts. with GLM use as 1st, 2nd, at least 3rd line respectively. PsARC response was achieved in 76.4%, 51.0% and 50.0% in first, second, and at least third line use of GLM, respectively at 24 months. AS pts (n=483) HLAB27-positive in 81.2%, 80.8%, and 74.1%, in pts. with GLM use as 1st, 2nd, at least 3rd line respectively. At BL 162 pts. had extra articular manifestations, most commonly iritis, enthesitis, IBD, and dactylitis (in 31.2%, 35.9%, and 43%, pts. respectively. Pts. with at least 2 previous bDMARDs had higher BASDAI at BL than pts. with GLM use in 1st or 2nd line: 5.7 vs. 5.0, and 4.9. After 24 months of treatment the mean BASDAI scores decreased significantly (p<0.001 vs. BL) to 2.1, 2.9, 2.9 in 1st, 2nd, and at least 3rd line use of GLM, respectively. Overall safety findings were comparable to those reported in controlled trials and no new safety signals were detected. RA DAS28-ESR 1st line (bDMARD-naïve) 2nd line 3rd line (at least) Month (mo) 0, BL mean DAS28 [SD] n=303 n=104 n=64 5.0 ± 1.3 4.9 ± 1.3 5.1 ± 1.5 mo 24: mean DAS28 [SD] p vs. BL n=128 n=32 n=24 2.9 ±1.3 <.0001 2.9 ± 1.3 <.0001 3.4 ± 1.5 <.0001 PsA PsARC 1st line (bDMARD-naïve) 2nd line 3rd line (at least) visit 1 mo 0, BL n=286 n=136 n=79 mo 24:PsARC. response n (%) n=113 n=25 n=12 76.4% 51.0% 50.0% AS BASDAI 1st line (bDMARD-naïve) 2nd line 3rd line (at least) mo 0, BL mean BASDAI [SD] n=290 n=130 n=58 5.0 ± 2.0 4.9 ± 2.0 5.7 ± 2.0 mo 24: mean BASDAI [SD] p vs. BL n=157 n=64 n=24 2.1 ±1.8 <.0001 2.9 ± 2.4 <.0001 2.9 ± 2.0 <.0001 Conclusion In this non-interventional study of pts. with RA, PsA and AS, golimumab therapy was effective, with better outcomes achieved in biologic-naïve pts. Significant improvement of DAS and BASDAI was also achieved with GLM use in second line. Third line use of GLM results in less benefit. References [1] K. Krüger, et al. BMJ Open2018 [2] K. Krüger, et al. Rheumatology International39 (1) 2019 Disclosure of Interests Klaus Krueger: None declared, Gerd Rüdiger Burmester Consultant for: Roche, Sanofi-Genzyme, Speakers bureau: Roche, Sanofi-Genzyme, Siegfried Wassenberg Grant/research support from: Roche Pharma, Consultant for: Abbvie, BMS, Chugai, Roche, Novartis, Pfizer, MSD, Speakers bureau: Abbvie, BMS, Pfizer, Janssen, Chugai, Celgene, Roche, Novartis, MSD, Astrid Thiele Consultant for: Biogen, Celgene, Chugai, Hexal, Janssen, Lilly, MSD, Novartis, Pfizer, UCB, Matthias Thomas Employee of: MSD Sharp & Dohme GmbH Germany