Background International recommendations for the management of axial spondyloarthritis including ankylosing spondylitis (AS) suggest a BASDAI level of disease activity of ≥4 to indicate treatment with biologics. Other cut-offs have rarely been studied so far.
Objectives Therefore, we were interested to learn about the level of disease activity used in daily routine to start anti-TNF therapy.
Methods In a posthoc subanalysis of the non-interventional, prospective, study GO-NICE that has been performed in a real life setting in Germany we used data from biologic naïve patients with established AS to study the initial BASDAI values before the start of therapy with Golimumab 50mg SC once monthly. Established standardized outcome measures were used.
Results Out of a total of 543 AS-patients (pts.) documented in 126 German centers, 244 biologic-naïve pts. were eligible. A total of 134 pts. (54.9%) completed the 24 month observational period. The majority of pts. (70.5%), had a BASDAI ≥4 (group (gr.).1), while 14.3% had a BASDAI of ≥2.8 - <4 (gr.2) and 15.1% even had a BASDAI <2.8 (gr.3, Table). The patient demographics did not differ much between these 3 groups, the proportion of males was numerically somewhat lower in gr.1. The proportion of pts. with an elevated CRP was highest in gr.2 at BL. The BASDAI in gr.1,2 and 3 was initially 5.9±1.3, 3.4±0.4 and 2.0±0.8, dropped significantly to 2.2*±2.0, 1.9*±1.2 and 1.0±1.2 within 3 months (*p<0.0001 vs. BL), and decreased significantly (p<0.005) to 2.2±1.7, 1.9±1.7 and 1.4±1.0 at month 24, respectively (fig.).The BASDAI 50% improvement was 68.8%, 44.8%, and 45.2% at month 3, and increased to 84.9%, 61.9%, and 55.0% at month 24, respectively.
Conclusions The most interesting observation of this real life study and posthoc analysis is certainly that almost a third of the pts. were included in the study who did not reach the recommended BASDAI cut-off of ≥4. Furthermore the data show that the patients with a BASDAI 2.8 - <4 seem to have significant benefit of anti-TNF treatment, while this was not really the case with in pts. with a BASDAI <2.8. This finding should lead to a reevaluation of the established BASDAI cut-off of ≥4. Future studies should also evaluate the performance of an ASDAS cut-off. It seems likely that especially pts. with elevated CRP levels and a BASDAI <4 will benefit from this new strategy. We think that in light of the rather weak correlation of pain and “objective” parameters of inflammation such as CRP and MRI the here reported observation does make some sense. Regarding the treatment with golimumab no new safety signals were detected.
Disclosure of Interest J. Braun Consultant for: AbbVie (Abbott), Amgen, Biogen, Boehringer Ingelheim, BMS, Celgene, Celltrion, Centocor, Chugai, EBEWE Pharma, Epirus, Hospira, Janssen, Medac, MSD (Schering-Plough), Mundipharma, Novartis, Pfizer (Wyeth), Roche, Sanofi-Aventis and UCB, X. Baraliakos Consultant for: AbbVie, Bristol-Myers Squibb, Celgene, Janssen, Novartis, Pfizer, Roche, MSD and UCB, U. Kiltz Consultant for: AbbVie, Chugai, Janssen, MSD, Novartis, Pfizer, Roche and UCB, K. Krüger Consultant for: AbbVie, BMS, Celgene, Janssen Biologics, MSD, Pfizer, Roche, and Sanofi-Aventis, G. Burmester Consultant for: AbbVie, BMS, MSD, Pfizer, Roche, and UCB, S. Wassenberg Consultant for: AbbVie, Chugai, Janssen Biologics, MSD, Novartis, Pfizer, Roche, and USB, M. Thomas Employee of: MSD Sharp & Dohme GmbH