Gensler L, Reveille J, Lee M, et al,
High Dose Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Tumor Necrosis Factor Inhibitor Use Results in Less Radiographic Progression in Ankylosing Spondylitis
- a Longitudinal Analysis. Arthr Rheum 2016; Vol 68, Supplement S10, 1956.
-This prospective cohort of 527 patients with at least 2 years of clinical and radiologic follow up demonstrated that slowing radiographic progression was greatest in those using both high-dose NSAIDs and TNFi. (OR 0.17, p=0.0033).
Baraliakos X,Schiff M, Pavelka K,et al,
Secukinumab Sustains Individual Clinical Responses over Time in Patients with Active Ankylosing Spondylitis: 2-Year Results from a Phase 3 Randomized Placebo-Controlled Trial
. Arthr Rheum 2016; Vol 68, Supplement S10, 695.
-72 patients in MEASURE 2(a phase 3, double-blind, randomized, placebo-controlled study) were randomized to receive secukinumab 150 mg at baseline, 60 patients (83.3%) completed 104 weeks of treatment. The majority of patients on secukinumab treatment the vast majority of patients who achieved either an ASAS 20 or ASAS 40 response at Wk 2 or 16 maintained or improved their response by Wks 16, 52, or 104, respectively.
Walsh J, Song X, Kim G, et al
,
Prevalence and Incidence of Comorbidities in Patients with Ankylosing Spondylitis versus General Population.
Arthr Rheum 2016; Vol 68, Supplement S10,719.
-This retrospective, observational cohort study used administrative claims data from 2007-2015 from the Truven Health MarketScan® Commercial Claims and Medicare Supplemental databases. AS patients had significantly higher rates of cardiovascular disease,depression, uveitis, sleep apnea, Crohn's disease, ulcerative colitis, osteoporosis, asthma, and gastrointestinal ulcers than controls (p<0.001)
Maksymowych W, Strand V, Nash P, et al,
Comparative Effectiveness of Secukinumab and Adalimumab in Ankylosing Spondylitis As Assessed By Matching-Adjusted Indirect Comparison: An Analysis Based on All Pivotal Phase 3 Clinical Trial Data.
Arthr Rheum 2016; Vol 68, Supplement S10,1739.
-Pooled Secukinumab (150 mg arms of MEASURE 1 (n=125) and MEASURE 2 (n = 72)) were weighted to match the published baseline characteristics of the Adalimumab 40 mg arm of ATLAS. Secukinumab 150 mg was associated with higher (non-placebo-adjusted) ASAS 20 response rates at weeks 16, 24 and 52 and ASAS 40 at weeks 24 and 52 relative to Adalimumab OR: 1.76 , p = 0.017 and OR: 1.79 p = 0.012, wk 24; week 52 (OR: 1.48 , p = 0.062 and OR: 1.54 , p = 0.023
Vidal C, Lukas C, Combe B, et al,
Efficacy of TNF Inhibitors in Axial Spondyloarthritis According to the Presence of Objective Signs of Inflammation: A Multicentric Retrospective Study.
Arthr Rheum 2016; Vol 68, Supplement S10, 1736.
-84 nr-axSpA patients without any objective sign and 84 axSpA patients with objective signs. Patients were mostly women (76.2%) with a mean ± standard deviation age of 42 ± 11 years. BASDAI 50 achievement rates were significantly higher in patients with objective signs than in patients without, at 3 months (45.1% versus 13.7%, p<0.0001) and over one year (61.9% versus 21.4% considering all time point for evaluation, p<0.0001). Overweight or obesity and sacroiliitis on MRI were respectively a negative and positive predictive factors of TNFi efficacy in multivariate analysis in the all population [OR = 0.32, p = 0.041 and OR = 6.92, p < 0.0001,
Maksymowych W, van der Heijde D, Baraliakos X, et al
,
Treatment with Tofacitinib Is Associated with Clinically Meaningful Reductions in Axial MRI Inflammation in Patients with Ankylosing Spondylitis
, Arthr Rheum 2016; Vol 68, Supplement S10,1044.
-In this 16-week, Phase 2, double-blind, dose-ranging study, 207 adult AS patients were randomized 1:1:1:1 to PBO or tofacitinib 2, 5, or 10 mg twice daily (BID) for 12 wks. MRI data for 164 patients were evaluated. All tofacitinib doses improved SIJ and spine scores vs PBO; In patients on tofacitinib, ASAS20, ASAS40, ASDAS MI, and ASDAS <1.3 responses were more likely in patients achieving MCID in SIJ, spine, or both SIJ and spine vs not achieving MCID. Patients on tofacitinib achieving MCID in SIJ had larger improvements in BASDAI, BASFI, and back pain.
van der Heijde D, Baraliakos X, Hermann K, et al
,
Four Year Imaging Outcomes in Patients with Axial Spondyloarthritis Treated with Certolizumab Pegol, Including Patients with Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
. Arthr Rheum 2016; Vol 68, Supplement S10,1042.
-RAPID-axSpA was double-blind, placebo (PBO)-controlled to Wk 24, dose-blind to Wk 48 and open-label to Wk 204 study. Limited spinal radiographic progression was observed in Certolizumab Pegol treated pts with lower progression between Wk 96 and Wk 204, compared to the first 96 wks. Limited change in radiographic sacroiliitis was observed and scores were even similar in both directions. Early reductions in MRI inflammation were maintained to Wk 204.
The RAPID-axSpA trial is the first study to report on the efficacy of an anti-TNF across the broad axSpA population, including both AS and nr-axSpA pts.
Deodhar A, Dougados M, Landewé R, et al
,
Safety and Efficacy of Certolizumab Pegol over 204 Weeks in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis
. Arthr Rheum 2016; Vol 68, Supplement S10,687
-218/325 pts were randomized to CZP from Wk 0, of whom 65% (n=142) completed to Wk 204 (AS: 67% [n=81]; nr-axSpA: 63% [n=61]). In the OL period, 9.2% of patients withdrew due to an adverse event and 1.4% due to lack of efficacy. The proportion of patients achieving ASAS20/40 and partial remission (PR) responses at Wk 24 was maintained to Wk 204 in pts remaining in the study with similar improvements in AS and nr-axSpA patients and in both CZP dose regimens. Spinal mobility (BASMI-linear) and function (BASFI) also improved in both subpopulations. 148 pts had BL enthesitis (MASES >0). Increasing proportions of this group achieved complete enthesitis clearance (MASES=0; OC): 39.6% at Wk 12, 52.5% at Wk 24, and 63.5% at Wk 204. No new safety signals were identified from Wk 96 to Wk 204, and no deaths were reported over 4 years.
de Bruin F, van den Berg R, Baraliakos X, et al
,
Scoring Syndesmophytes on CT Spine Images of Patients with Radiographic Axial Spondyloarthritis from the Sensitive Imaging of Axial Spondyloarthritis (SIAS) Cohort.
Arthr Rheum 2016; Vol 68, Supplement S10, 3160.
Sensitive Imaging of Axial Spondyloarthritis (SIAS) cohort had at least 1 syndesmophyte in cervical or lumbar spine on radiographs. Baseline and 2 years follow up CT scans were performed. 58 pts (47 male, mean age 50.4) were included. Both readers use almost the entire possible range, pick up a similar magnitude of change and have high ICCs. Most change is present in the thoracic spine. A change 3SDC is seen in 33.9% of the patients.