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Clinical Trial
. 2017 Jul;69(7):1030-1039.
doi: 10.1002/acr.23092. Epub 2017 Jun 2.

Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis

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Free PMC article
Clinical Trial

Early Disease Activity or Clinical Response as Predictors of Long-Term Outcomes With Certolizumab Pegol in Axial Spondyloarthritis or Psoriatic Arthritis

D van der Heijde et al. Arthritis Care Res (Hoboken). .
Free PMC article

Abstract

Objective: Early identification of patients unlikely to achieve good long-term disease control with anti-tumor necrosis factor therapy in axial spondyloarthritis (SpA) and psoriatic arthritis (PsA) is important for physicians following treat-to-target recommendations. Here we assess associations between disease activity or clinical response during the first 12 weeks of treatment and attainment of treatment targets at week 48 in axial SpA and PsA patients receiving certolizumab pegol.

Methods: The relationship between disease activity or clinical response during the first 12 weeks of treatment and achievement of week-48 targets (for axial SpA: inactive disease based on Ankylosing Spondylitis Disease Activity Score [ASDAS] using the C-reactive protein [CRP] level, or Bath Ankylosing Spondylitis Disease Activity Index <2 with normal CRP level; and for PsA: minimal disease activity) was assessed post hoc using RAPID-axSpA and RAPID-PsA trial data.

Results: A clear relationship between disease activity from week 2 to 12 and achievement of week-48 treatment targets was observed in both axial SpA and PsA populations. In axial SpA, week-48 ASDAS inactive disease was achieved by 0% of patients (0 of 21) with ASDAS very high disease activity at week 12, compared to 68% of patients (34 of 50) with week-12 ASDAS inactive disease. For PsA, week-48 minimal disease activity was achieved by 0% of patients (0 of 26) with Disease Activity Score in 28 joints (DAS28) using the CRP level >5.1 at week 12, compared to 73% of patients (57 of 78) with DAS28-CRP <2.6. Similar results were observed regardless of the disease activity measure used. Clinical response at week 12 also predicted week-48 outcomes, though to a lesser extent than disease activity.

Conclusion: Using disease activity and the clinical response state during the first 12 weeks of certolizumab pegol treatment, it was possible to identify a subset of axial SpA and PsA patients unlikely to achieve long-term treatment goals.

Trial registration: ClinicalTrials.gov NCT01087762 NCT01087788.

Figures

Figure 1
Figure 1
Proportion of patients achieving disease activity targets at week 48 based on classification of disease activity at baseline, week 2, week 8, and week 12. Values are the number/total number (percentage). * = the number of axial spondyloarthritis (SpA) patients at each visit: 218 at baseline, 217 at week 2, 215 at week 8, and 211 at week 12. † = the number of psoriatic arthritis (PsA) patients at each visit: 272 at baseline, 270 at week 2, 262 at week 8, and 256 at week 12. ASDAS = Ankylosing Spondylitis Disease Activity Score; ID = inactive disease; MD = moderate disease; HD = high disease; vHD = very high disease; BASDAI = Bath Ankylosing Spondylitis Disease Activity Index; CRP = C‐reactive protein; ULN = upper limit of normal; MDA = minimal disease activity; DAS28 = Disease Activity Score in 28 joints.
Figure 2
Figure 2
Disease activity at week 12 successfully predicts lack of attainment of treatment targets. axSpA = axial spondyloarthritis; AS = ankylosing spondylitis; nr = nonradiographic; PsA = psoriatic arthritis; minDA = minimal disease activity. See Figure 1 for other definitions.
Figure 3
Figure 3
Likelihood of achieving disease activity targets at week 48 based on clinical response or on achievement of patient‐reported outcome responses at early time points. Values are the number/total number (percentage). * = the number of axial spondyloarthritis (SpA) patients at each visit: 218 at baseline, 217 at week 2, 215 at week 8, and 211 at week 12. † = the number of PsA patients at each visit: 272 at baseline, 270 at week 2, 262 at week 8, and 256 at week 12. MI = major improvement; CII = clinically important improvement; MCID = minimal clinically important difference; PsARC = Psoriatic Arthritis Response Criteria. See Figure 1 for other definitions.
Figure 4
Figure 4
Clinical response at week 12 predicts lack of attainment of treatment targets moderately well. axSpA = axial spondyloarthritis; AS = ankylosing spondylitis; nr = nonradiographic; MI = major improvement; CII = clinically important improvement; PsA = psoriatic arthritis; minDA = minimal disease activity; PsARC = Psoriatic Arthritis Response Criteria. See Figure 1 for other definitions.
Figure 5
Figure 5
Heat map representing Ankylosing Spondylitis Disease Activity Score (ASDAS) disease activity at each visit grouped by patients' week‐12 ASDAS category and sorted by baseline ASDAS.

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