Background/Purpose: To investigate changes in inflammation and structural progression in the sacroiliac joints (SIJs) in patients with axial spondyloarthritis (SpA) during treatment with adalimumab and placebo in a randomized double-blind placebo-controlled trial, as assessed by two different MRI methods.

Methods: Fifty-one patients with axial SpA were treated with adalimumab 40 mg (n=26) or placebo (n=25) sc. e.o.w. for 12 weeks, followed by an open label extension phase of 36 weeks where all patients received adalimumab. MRIs of the SIJs were performed at weeks 0, 12, 24 and 48. Two rheumatologists evaluated the images in random order, blinded for clinical, biochemical and other imaging data with either the Berlin method (reader DP)(1) or the SPondyloArthritis Research Consortium of Canada (SPARCC) MRI Sacroiliac Joint Inflammation (2) and Structural Score (reader SJP)(2). By the Berlin method scoring ranges are: Inflammation (INF): 0-24, fat (FAT): 0-24, erosions (ER): 0-6, sclerosis (SCL): 0-2, and ankylosis (ANK): 0-2. In the SPARCC method scoring ranges are: inflammation (INF): 0-60, fat (FAT): 0-50, erosions (ER): 0-40, backfill (BF): 0-20, ankylosis (ANK): 0-20. The structural lesions are defined according to standardized and validated definitions (Morpho)(3).

Results: According to the Berlin method, INF decreased significantly in the adalimumab group from week 0 to 12 (Wilcoxon-Pratt; p=0.01), while the placebo group decreased from week 0 to 24 (p<0.01), i.e when patients had received 12 weeks of open-label adalimumab (Table 1). Berlin scores for FAT, ER, ANK and SCL did not change in any of the groups. According to the SPARCC method, INF decreased significantly in both treatment groups (p<0.05) from baseline to all time points. In patients treated with adalimumab, FAT increased from week 0 to 24 and 48 (p<0.03) and BF increased from week 0 to 12 (p<0.02). ANK increased from week 0 to 48 in both treatment groups (p<0.03), and ER decreased from week 0 to 24 and 48 (p<0.02) in the placebo group. At baseline, no differences between the treatment groups as assessed by the two scoring methods, besides that SPARCC ANK was higher in patients treated with adalimumab (Mann-Whitney; p<0.05)(Table 1). At week 12, INF was significantly lower in the adalimumab group than the placebo group, both by the Berlin (p<0.003) and the SPARCC (p<0.002) methods, and ER was lower when assessed by the SPARCC method (p<0.01).

Conclusion: After 12 weeks of therapy, SIJ inflammation was lower in adalimumab than placebo treated patients. The Berlin and SPARCC methods are both sensitive for changes in inflammation, while the SPARCC method may be more sensitive for changes in structural lesions.

Table 1 Berlin and SPARCC MRI scores for inflammation and structural lesions in the SIJs

	Berlin
	Adalimumab			Placebo
	0	12	24	0	12	24
INF	1   (0-14)	0   (0-6)*	1   (0-6)	2   (0-18)	2   (0-24)	1   (0-10)*
FAT	15   (1-24)	16   (1-24)	15.5   (1-24)	12   (2-24)	13   (2-14)	13   (3-24)
ER	3   (0-6)	3   (0-6)	2   (0-6)	4   (0-6)	4   (0-6)	4   (0-6)
SCL	0   (0-2)	0   (0-2)	0   (0-2)	2   (0-2)	2   (0-2)	2   (0-2)
ANK	0   (0-2)	0   (0-2)	0.5   (0-2)	0   (0-2)	0   (0-2)	0   (0-2)
	SPARCC
	Adalimumab			Placebo
	0	12	24	0	12	24
INF	0.5   (0-37)	0   (0-17)*	0 (0-18)*	5   (0-39)	4   (0-40)*	2 (0-26)**
FAT	15 (0-50)	17   (0-50)	17.5 (0-50)	9   (0-41)	9   (0-41)	10   (0-45)
ER	0   (0-8)	0   (0-4)	0 (0-13)	2   (0-20)	2   (0-20)	0 (0-8)**
BF	3.5   (0-20)	4.5   (0-20)*	4.5 (0-20)	4   (0-15)	6   (0-15)	7   (0-17)
ANK	3   (0-20)	3.5   (0-20)	4 (0-20)	0   (0-20)	0   (0-20)	0 (0-20)

Results are median (range). *p<0.05; **p<0.01; Wilcoxon-Pratt test.

References: 1: Song et al. Ann Rheum Dis 2011. 2. Maksymowych et al. Arthritis Rheum. 3: Weber et al. Arthritis Rheum 2010.

---

« Back to 2013 ACR/ARHP Annual Meeting

ACR Meeting Abstracts - https://acrabstracts.org/abstract/inflammation-and-structural-progression-in-the-sacroiliac-joints-of-patients-with-axial-spa-treated-with-adalimumab-or-placebo-as-assessed-by-the-berlin-and-the-spondyloarthritis-research-consortium-o/