J.C. has served as a consultant for. AbbVie and Amgen; is a member of a speakers' bureau for AbbVie; and has received grants/research support AbbVie, ...
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APR30 if they were initially randomized to placebo, or continued on their initial APR dose, through Week 24. At Week 24, all remaining placebo patients were re-randomized to APR20 or APR30. Concurrent treatment with stable doses of MTX, LEF, SSZ, or combination was allowed. Results: 505 patients were randomized and received 1 dose of study medication (placebo, n ¼ 169; APR20, n ¼ 169; APR30, n ¼ 167). At Week 16 (primary endpoint) for the per-protocol population, significantly more APR20 (29.4%; P ¼ 0.0235) and APR30 (42.8%; P < 0.0001) patients achieved a modified ACR20 response vs placebo (18.9%). Among patients initially randomized to APR at baseline and receiving APR for 52 weeks, improvements were maintained or increased over 52 weeks for multiple endpoints, including (1) modified ACR20 response of 56.0% (APR20) and 63.0% (APR30); (2) HAQ-DI mean (S.D.) change from baseline of 0.332 (0.505) for APR20 and 0.350 (0.505) for APR30 patients, meeting the MCIDs of 0.13 and 0.30; and (3) PASI-75 achievement of 28.6% (APR20) and 39.1% (APR30) and PASI-50 achievement of 49.2% (APR20) and 54.7% (APR30) in patients with baseline BSA 3%. Patients re-randomized to APR at Week 16 or 24 demonstrated results consistent with patients randomized to APR at baseline. APR was generally well tolerated. The nature and severity of adverse events (AEs) did not change with longterm exposure. The most common AEs (5% of patients) over 52 weeks were diarrhoea, nausea, headache, URTI, nasopharyngitis, and vomiting. Most AEs were mild to moderate in severity and did not lead to discontinuation. Gastrointestinal AEs tended to be self-limited with a low proportion leading to treatment discontinuation. For patients treated with APR, serious AEs occurred in 5.4% (APR20) and 4.1% (APR30) of patients. Marked laboratory abnormalities were infrequent and transient, showed no trends or patterns, and may not indicate a need for laboratory monitoring. No clinically meaningful differences in rates of MACE, serious infections, or malignancies were observed between APR and placebo. No cases of tuberculosis (new or reactivation) were reported in the APR treatment groups (no screening for latent tuberculosis required). Conclusion: Over 52 weeks, APR demonstrated clinically meaningful improvements in the signs/symptoms of PsA, physical function, and associated psoriasis. APR demonstrated an acceptable safety profile and was generally well tolerated. Disclosure statement: C.J.E. has served as a consultant for Samsung, Roche and Celgene; is a member of a speakers’ bureau for Roche, Pfizer, Abbott and GSK; and has received grants/research support from Pfizer. F.J.B. has served as a consultant for Pfizer, Bioiberica and Gebro Farma. J.C. has served as a consultant for AbbVie and Amgen; is a member of a speakers’ bureau for AbbVie; and has received grants/research support AbbVie, Amgen, Celgene, Janssen, Merck and Pfizer. C.H. is an employee of Celgene. R.M.S. is an employee of Celgene. C.A.B. has received grants/research support for clinical trials from Amgen, Lilly, Pfizer, Incyte, Merck and BristolMyers Squibb.
213. EFFECT OF CERTOLIZUMAB PEGOL ON INFLAMMATION OF SPINE AND SACROILIAC JOINTS IN PATIENTS WITH AXIAL SPONDYLOARTHRITIS: 12-WEEK MAGNETIC RESONANCE IMAGING RESULTS OF RAPID-AXSPA STUDY De´sire´e van der Heijde1, Walter P. Maksymowych2, Robert Landewe´3,4, Christian Stach5, Bengt Hoepken5, Andreas Fichtner5, Danuta Kielar6 and Juergen Braun7 1 Department of Rheumatology, Leiden University Medical Center, Leiden, Netherlands, 2Department of Medicine, University of Alberta, Edmonton, AB, Canada, 3Department of Internal Medicine/ Rheumatology, Academic Medical Center, Amsterdam, Netherlands, 4 Atrium Medical Center, Heerlen, Netherlands, 5UCB Pharma, Monheim, Germany, 6UCB Pharma, Brussels, Belgium, 7 Rheumazentrum Ruhrgebiet, Herne, Germany Background: Axial spondyloarthritis (axSpA) includes both AS and axSpA with no definitive sacroiliitis on X-ray (non-radiographic axSpA, nr-axSpA). One of the features of axSpA is bone marrow edema of sacroiliac joints (SIJ) and spine. RAPID-axSpA (NCT01087762) investigated certolizumab pegol (CZP), a PEGylated Fc-free anti-TNF, efficacy and safety in patients with axSpA, including AS and nr-axSpA. The objective was to report the impact of CZP on inflammation of spine and SIJ in axSpA patients using MRI. Methods: The ongoing 158-week Phase 3 RAPID-axSpA trial was double-blind, placebo controlled to Wk24. Recruited patients had adultonset active axSpA according to the ASAS criteria, and included AS patients also meeting the modified New York criteria and nr-axSpA patients. Patients must have failed 1 NSAID. Patients were randomized 1:1:1 to placebo (PBO) every 2 weeks (Q2W), or 400 mg CZP at Wk0, 2 and 4 (loading dose) followed by either 200 mg CZP Q2W or 400 mg CZP
every 4 weeks (Q4W). MRI scans of the SIJ and spine were evaluated using an analysis of covariance model. MRI endpoints were least square difference to PBO in change from baseline in the Spondyloarthritis Research Consortium of Canada (SPARCC) SIJ score for inflammation and Berlin modification of AS spine MRI score for disease activity in the spine (ASspiMRI-a). Data are reported for all patients included in imaging sub-study (the MRI set). Results: 325 patients were randomized, of which 153 were included in the MRI set. Baseline characteristics were similar across the MRI set, and were representative of overall RAPID-axSpA patient population. Baseline SPARCC MRI SIJ scores were comparable between AS and nr-axSpA populations, while Berlin ASspiMRI-a scores were higher in AS patients. Improvements in SPARCC MRI SIJ scores and ASspiMRIa Berlin modification were observed in both CZP dose arms compared with PBO in the overall, and both AS and nr-axSpA, populations (Table 1). Greater reductions in SIJ inflammation were observed for patient subgroups with
