Background Axial spondyloarthritis (axSpA) is characterized by inflammation of the spine. However, the disease can also be associated with extra-spinal manifestations such as inflammation of the entheses (enthesitis) and peripheral joints, which can add to the burden of disease. RAPID-axSpA (NCT01087762) is a Phase 3 clinical trial of certolizumab pegol (CZP) in patients (pts) with axSpA including pts with (ankylosing spondylitis [AS]) or without (non-radiographic axSpA [nr-axSpA]) radiographic damage of the sacroiliac joints.1
Objectives To report the impact of CZP treatment on enthesitis (measured by Maastricht Ankylosing Spondylitis Enthesitis Score [MASES]) and peripheral joint swelling and tenderness.
Methods The RAPID-axSpA trial was double-blind and placebo (PBO)-controlled to Week (Wk) 24. Pts fulfilled ASAS criteria and had active axSpA. Pts were originally randomized 1:1:1 to either CZP 200mg Q2W, 400mg Q4W (following 400mg loading dose at Wks 0, 2, 4) or PBO. Enthesitis (MASES; count of 0–13 affected sites), swollen joints (SJC; 0–66 joints) and tender joints (TJC; 0–68 joints) were assessed at baseline and at each study visit to Wk24. Data are presented here for the subsets of pts within the Full Analysis Set (FAS) with ≥1 swollen joint, ≥1 tender joint or ≥1 enthesial site affected at baseline. LOCF imputation was used for pts escaping to CZP, withdrawing or having missing measurements. No analyses of statistical significance were carried out on these data.
Results At baseline, of the 324 pts in the FAS, 229 had enthesitis in ≥1 enthesial site, with a mean MASES score of 5.1; 123 had ≥1 swollen joint, with a mean SJC of 4.2; and 212 had ≥1 tender joint, with a mean TJC of 6.6. Improvements were seen in all three extra-spinal measures following CZP treatment. At Wk24 the mean change from baseline in MASES for CZP-treated pts was -2.9 compared to -0.9 for PBO pts; for SJC the mean change from baseline for CZP pts was -2.8 compared to -0.7 for PBO pts; and for TJC the mean change from baseline for CZP pts was -2.7 compared to -0.4 in PBO pts. Baseline severity of extra-spinal manifestations and improvements observed to Wk24 were similar between the AS and nr-axSpA subpopulations (Table). Improvements were also similar between both CZP dosing regimens (data not shown).
Conclusions CZP treatment of axSpA patients was associated with a marked improvement in measures of enthesitis and extra-spinal joint inflammation. Similar improvements were seen in both the AS and nr-axSpA subpopulations.
Landewé R. Ann Rheum Dis 2014;73:39-47
Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance which was funded by UCB Pharma.
Disclosure of Interest P. Mease Grant/research support: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Vertex, Consultant for: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Celgene, Crescendo, Genentech, Janssen, Lilly, Merck, Novartis, Pfizer, UCB Pharma, Vertex, Speakers bureau: (Abbott) AbbVie, Amgen, BiogenIdec, BMS, Crescendo, Genentech, Janssen, Lilly, Pfizer, UCB Pharma, M. Dougados Grant/research support: UCB Pharma, Abbvie, Pfizer, Lilly, Novartis, Consultant for: UCB Pharma, Abbvie, Pfizer, Lilly, Novartis, O. Davies Shareholder of: UCB Pharma, Employee of: UCB Pharma, T. Nurminen Employee of: UCB Pharma, J. Sieper Consultant for: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen, Speakers bureau: Abbott, Merck, Pfizer, UCB Pharma, Novartis, Lilly, Janssen