Background The first double-blind placebo controlled RCT (EudraCT nr 2006-000925-71) studied the efficacy and safety of adalimumab in 60 patients with erosive osteoarthritis of the interphalangeal finger joints (EOA) during 52 weeks. Inflamed IP joints (with palpable swelling) were found to be at risk to develop further destructive/erosive stages. 14.5% of the inflamed, and 3.7% of the non inflamed IP joints showed destructive/erosive evolution (p=0.009). Adalimumab treatment reduced the progresse to erosive stages of inflamed IP joints to 3.6% (1).
Objectives To study the 1-year radiographic progression of an open-label extension (OLE) study with adalimumab (40mg, eow, sc).
Methods Hand Xrays were taken after 6 and 12 months of treatment in the OLE. The progression was scored by the GUSS and anatomical phase scoring system. Comparison was made between the radiographs taken after 12 months and baseline of OLE. The number of new erosive joints was determined. Mean differences in total GUSS scores were calculated.
Results Fifty of 60 patients enrolled in the OLE. One of 49 (2.0%) inflamed (i.e. effusion upon palpation) interphalangeal joints at baseline of this OLE and 6 of 228 (2.6%) non-inflamed joints became erosive under treatment with adalimumab (p = NS).
The evolution in 148 of the initial 188 target joints (the RCT study phase) was analysed. Two joints became erosive (1.4%). Six joints showed extreme signs of remodellation (“F“ phase, ankylosis) (4.1%). The mean GUSS mean change after one year in OLE was +22.2 (SD 35) (p<0.03), indicating overall remodellation.
The mean GUSS change after 12 months in OLE between patients initially treated with adalimumab in RCT did not differ from patients initially treated with placebo (22.1 vs. 22.3, p=0.96).
Conclusions Follow-up radiographic data confirm the potency of adalimumab to delay the radiographic progression in EOA.
G. Verbruggen, R. Wittoek, B. Vander Cruyssen and D. Elewaut. Tumour necrosis factor blockade for the treatment of erosive osteoarthritis of the interphalangeal finger joints: a double blind, randomised trial on structure modification. ARD 2011 Nov 29. [Epub ahead of print]
Disclosure of Interest None Declared