Background Dactylitis and enthesitis are common disabling manifestations of psoriatic arthritis (PsA) that have been reported according to multiple methods of assessment. Several measures of dactylitis and enthesitis were utilized in the phase 3 FUTURE 2 secukinumab study (NCT01752634)1 and are reported here.
Objectives To evaluate the effects of subcutaneous (s.c.) secukinumab on dactylitis and enthesitis through Week (Wk) 24 in FUTURE 2.
Methods 397 adults with active PsA were randomized to s.c. secukinumab (300, 150 or 75 mg) or PBO at baseline, Wk 1, 2, 3, 4 and then every 4 wks thereafter. The primary endpoint was ACR20 response at Wk 24. The proportions of pts with resolution of dactylitis and enthesitis at Wk 24 (of those with these conditions at baseline) were secondary endpoints. Additional measures utilized in this study were dactylitis counts, Leeds Dactylitis Index (LDI), and Leeds Enthesitis Index (LEI).
Results At baseline, 138 pts (35%) had dactylitis and 253 pts (64%) had enthesitis. At Wk 24, comparing secukinumab 300 mg and 150 mg vs PBO respectively, 56.5% and 50.0% vs 14.8% of pts had complete resolution of dactylitis, and 48.2% and 42.2% vs 21.5% had complete resolution of enthesitis. Corresponding reductions in LDI, LEI and mean dactylitis counts were observed (Table).
Conclusions Across multiple methods of assessment, secukinumab 300 and 150 mg s.c. reduced the number of dactylitic digits and enthesitis sites in pts with PsA and was associated with a greater proportion of patients achieving complete resolution of dactylitis/enthesitis compared with PBO.
McInnes IB, et al. Presented at ACR 2014; L1
Acknowledgements Medical writing support was provided by Rachel Mason at Seren Communications (Tytherington, UK), and was funded by Novartis.
Disclosure of Interest B. Kirkham Grant/research support from: AbbVie and UCB, Consultant for: Novartis, AbbVie, BMS, Lilly, and MSD, Speakers bureau: BMS, MSD, and UCB, I. McInnes Consultant for: Novartis, Amgen, Janssen, BMS, Pfizer, UCB, Abbvie, Celgene, and Lilly, P. Mease Grant/research support from: AbbVie, Amgen, Biogen Idec, BMS, Celgene, Crescendo, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, and Vertex, Consultant for: AbbVie, Amgen, Biogen Idec, BMS, Celgene, Covagen, Crescendo, Janssen, Lilly, Merck, Novartis, Pfizer, UCB, and Vertex, Speakers bureau: AbbVie, Amgen, Biogen Idec, BMS, Crescendo, Janssen, Lilly, Pfizer, and UCB, J. Kremer Grant/research support from: Novartis, Lilly, BMS, Janssen, Pfizer, and UCB, S. Kandala Employee of: Novartis, L. Pricop Shareholder of: Novartis, Employee of: Novartis, S. Mpofu Shareholder of: Novartis, Employee of: Novartis