POS0902 EFFICACY AND SAFETY OF INTRAVENOUS GOLIMUMAB IN ANKYLOSING SPONDYLITIS PATIENTS WITH EARLY VS LATE DISEASE THROUGH WEEK 52 OF GO-ALIVE STUDY
Authors: Deodhar A. , Kafka S. , Hsia E. C. , Lo K. H. , Kim L. , Xu S. , Reveille J. D. 
Published: May 2021

Background:

The GO-ALIVE study assessed efficacy and safety of intravenous golimumab (IV GLM) in patients (pts) with ankylosing spondylitis (AS).1,2

Objectives:

In this post hoc analysis, we assessed IV GLM efficacy and safety in AS pts with early disease (ED) vs late disease (LD) based on pt-reported duration of inflammatory back pain (IBP).

Methods:

In this Phase 3, double-blind, placebo (PBO)-controlled trial, pts with active AS were randomized (1:1) to receive IV GLM 2 mg/kg at Week (W) 0, W4, then Q8W or PBO at W0, W4, and W12 with crossover to IV GLM at W16, W20, then Q8W through 52. The primary endpoint was achievement of SpondyloArthritis International Society 20% improvement response (ASAS 20) at W16. In this post hoc analysis, 208 pts were grouped into quartiles based on self-reported duration of IBP symptoms. Efficacy and safety in 60 pts with ED (1st quartile) were compared with 52 pts with LD (4th quartile).

Results:

For the overall study population, mean duration of IBP symptoms was 10.9 yr and mean time since diagnosis was 5.5 yr. For ED pts, the mean duration of IBP symptoms ranged from 2.3 yr (IV GLM) to 2.6 yr (PBO), and for LD pts ranged from 23.5 yr (IV GLM) to 24.4 yr (PBO). At W16, ASAS 20 was achieved by 72% IV GLM vs 32% PBO pts with ED and by 67% IV GLM vs 21% PBO pts with LD. Pts with ED had numerically better response than those with LD in Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), and across more stringent endpoints, including ASAS 40, Bath Ankylosing Spondylitis Disease Activity Index 50% improvement (BASDAI 50), and Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease and major improvement (Table 1). Response rates at W16 among IV GLM-treated pts were generally consistent through 1 year in both ED and LD subgroups; also in ED and LD subgroups, pts crossing over to IV GLM at W16 demonstrated response at W52 consistent with pts who started IV GLM at W0. At W16, improvements in enthesitis score were similar for pts with ED (mean change -2.9 for IV GLM vs 0.1 for PBO) and LD (mean change -2.5 for IV GLM vs 0.6 for PBO); improvements were maintained at W52 for ED and LD pts. Treatment-emergent adverse events and serious adverse events through 1 year were 46% and 3% for pts with ED compared with 61% and 2% for pts with LD, respectively.

Conclusion:

While IV GLM provided clinically meaningful improvements in signs and symptoms of AS in pts regardless of disease duration, response generally appeared numerically better in pts with ED than in pts with LD. This supports the principle of prompt diagnosis and early treatment.

References:

[1]Deodhar A, et al. J Rheumatol. 2018;45:341-348.

[2]Reveille J, et al. J Rheumatol. 2019;46:1277-1283.

Table 1.

Efficacy Outcomes

EDLDWeek 16Week 52Week 16Week 52PBO
(n=25)IV GLM
(n=35)PBO→IV GLM
(n=25)IV GLM
(n=35)PBO
(n=28)IV GLM
(n=24)PBO→IV GLM
(n=28)IV GLM
(n=24)ASAS 2032%71%68%71%21%67%68%63%ASAS 4012%46%56%60%4%42%57%42%BASDAI 5012%40%64%60%7%33%57%42%ASDAS inactive disease (score <1.3)4%17%44%37%0%8%14%4%ASDAS major improvement (decrease ≥2.0)n=24
4%57%n=24
54%51%0%n=23
48%46%n=23
30%ASDAS clinically important improvement (decrease ≥1.1)n=24
29%77%n=24
75%77%18%n=23
91%61%n=23
65%Mean change from baseline (SD) in BASFIn=23
-0.4 (2.0)-2.3 (2.1)n=23
-2.7 (2.7)-2.8 (2.6)n=27
-0.3 (1.8)n=24
-2.2 (1.7)n=27
-2.4 (2.2)n=23
-2.3 (1.7)Mean change from baseline (SD) in BASMIn=23
-0.3 (0.7)-0.4 (0.7)n=23
-0.6 (0.7)-0.3 (0.5)n=27
0.01 (0.5)n=21
-0.3 (0.6)n=27
-0.4 (0.7)n=20
-0.3 (0.7)Mean change from baseline (SD) in enthesitis scoren=23
0.1 (3.6)-2.9 (2.9)n=23
-2.0 (4.4)-3.2 (2.5)n=27
-0.6 (3.4)n=21
-2.5 (3.0)n=27
-2.5 (3.1)n=20
-3.5 (5.9)

SD=standard deviation

Disclosure of Interests:

Atul Deodhar Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and UCB, Shelly Kafka Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Elizabeth C Hsia Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Kim Hung Lo Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Lilianne Kim Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, Stephen Xu Shareholder of: Johnson & Johnson, Employee of: Janssen Research & Development, LLC, John D Reveille Consultant of: Eli Lilly and UCB, Grant/research support from: Eli Lilly and Janssen