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Background: C-OPTIMISE is the first trial to evaluate whether certolizumab pegol (CZP) can be reduced/discontinued in patients with radiographic (r) axSpA/ankylosing spondylitis (AS) and non-radiographic (nr) axSpA achieving sustained remission after 48 weeks’ treatment. Here, we report interim efficacy and safety data for both subpopulations from the ongoing trial.

Methods: Up to week 48, C-OPTIMISE (NCT02505542) was open-label (Part A), followed by 48-week parallel-group, double-blind, placebo-controlled treatment to week 96 (Part B). Patients with adult-onset axSpA of < 5 years’ duration, fulfilling ASAS classification criteria, were recruited. Part A: patients received CZP (400mg at weeks 0/2/4, then 200mg Q2W); patients achieving sustained remission (ASDAS<1.3 at week 32 and <2.1 at week 36 [or vice versa], and <1.3 at week 48) were eligible for Part B. Primary outcome (not reported): percentage of patients in Part B not experiencing a flare. Missing values were imputed using non-responder imputation (NRI) and last observation carried forward (LOCF).

Results: Part A: of 736 patients (Table 1), 43.9% achieved sustained remission (r-axSpA/AS: 42.8%; nr-axSpA: 45.3%; NRI). At baseline, 98.5% patients had high/very high disease activity (ASDAS⩾2.1); at week 48, 52.7% (r-axSpA/AS: 52.6%; nr-axSpA: 52.9%) had inactive disease (ASDAS<1.3; LOCF). The treatment-emergent adverse event (TEAE) rate/100 patient-years’ exposure was 224.2; 3.9% patients discontinued CZP due to TEAEs. No new safety signal was identified.

Conclusion: These results show that similar and substantial proportions of patients with r-axSpA/AS and nr-axSpA achieved sustained remission during 48 weeks’ CZP treatment. No new safety signal was identified.

E098 Table
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Baseline Characteristics and Clinical Outcomes
axSpA (n = 736)r-axSpA/AS (n = 407)nr-axSpA (n = 329)
Baseline Characteristics
Age (years), mean (SD)32.9 (7.0)33.7 (6.8)32.1 (7.1)
Male, n (%)513 (69.7)318 (78.1)195 (59.3)
Symptom duration (years), mean (SD) [a]2.2 (1.7)2.5 (1.8)1.8 (1.6)
HLA-B27 positive, n (%)597 (81.1)354 (87.0)243 (73.9)
Sacroiliitis on imaging, n (%) [b]691 (93.9)401 (98.5)290 (88.1)
Prior anti-TNF treatment, n (%)31 (4.2)20 (4.9)11 (3.3)
Clinical Outcomes
%BLWk48 (NRI)BLWk48 (NRI)BLWk48 (NRI)
ASAS20-79.6-79.9-79.3
ASAS40-72.0-71.3-72.9
ASAS PR-57.3-55.8-59.3
BASDAI 50-71.7-71.3-72.3
Mean [c]BLWk48 (LOCF [c])BLWk48 (LOCF [c])BLWk48 (LOCF [c])
ASDAS3.71.63.81.63.61.5
HDA/VHDA,%98.524.7†98.525.898.523.2‡
ID, %-52.7†-52.6-52.9‡
CII, % [d]-76.5-78.6-73.9
MI, % [d]-56.3-58.7-53.2
BASDAI6.72.16.72.16.72.2
BASFI5.31.75.41.75.11.6
BASMI3.12.33.52.62.71.9
Nocturnal back pain6.91.87.01.86.81.8
Fatigue7.12.67.12.57.12.6
CRP (mg/L), median7.82.010.72.04.52.0
Baseline Characteristics and Clinical Outcomes
axSpA (n = 736)r-axSpA/AS (n = 407)nr-axSpA (n = 329)
Baseline Characteristics
Age (years), mean (SD)32.9 (7.0)33.7 (6.8)32.1 (7.1)
Male, n (%)513 (69.7)318 (78.1)195 (59.3)
Symptom duration (years), mean (SD) [a]2.2 (1.7)2.5 (1.8)1.8 (1.6)
HLA-B27 positive, n (%)597 (81.1)354 (87.0)243 (73.9)
Sacroiliitis on imaging, n (%) [b]691 (93.9)401 (98.5)290 (88.1)
Prior anti-TNF treatment, n (%)31 (4.2)20 (4.9)11 (3.3)
Clinical Outcomes
%BLWk48 (NRI)BLWk48 (NRI)BLWk48 (NRI)
ASAS20-79.6-79.9-79.3
ASAS40-72.0-71.3-72.9
ASAS PR-57.3-55.8-59.3
BASDAI 50-71.7-71.3-72.3
Mean [c]BLWk48 (LOCF [c])BLWk48 (LOCF [c])BLWk48 (LOCF [c])
ASDAS3.71.63.81.63.61.5
HDA/VHDA,%98.524.7†98.525.898.523.2‡
ID, %-52.7†-52.6-52.9‡
CII, % [d]-76.5-78.6-73.9
MI, % [d]-56.3-58.7-53.2
BASDAI6.72.16.72.16.72.2
BASFI5.31.75.41.75.11.6
BASMI3.12.33.52.62.71.9
Nocturnal back pain6.91.87.01.86.81.8
Fatigue7.12.67.12.57.12.6
CRP (mg/L), median7.82.010.72.04.52.0

Table Footnote: [a] Time since diagnosis of disease. [b] MRI/Xray. [c] Unless stated otherwise. [d] NRI. †n=734. ‡n=327. ASAS20/40: ≥20%/≥40% improvement in assessment of spondyloarthritis international society response criteria; PR: Partial Remission; ASDAS: Ankylosing Spondylitis Disease Activity Score; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASDAI 50: ≥50% improvement in BASDAI; BASFI: Bath Ankylosing Spondylitis Functional Index; BASMI: Bath Ankylosing Spondylitis Metrology Index; CII: Clinically Important Improvement (RFB ≥1.1); CRP: C-reactive protein; CZP: certolizumab pegol; HDA/VHDA: High/Very High Disease Activity (ASDAS≥2.1); ID: Inactive Disease (ASDAS <1.3); LOCF: last observation carried forward; MI: ASDAS Major Improvement (RFB ≥2.0); (n)r: (non)radiographic; NRI: non-responder imputation; RFB: reduction from baseline.

E098 Table
Open in new tab
Baseline Characteristics and Clinical Outcomes
axSpA (n = 736)r-axSpA/AS (n = 407)nr-axSpA (n = 329)
Baseline Characteristics
Age (years), mean (SD)32.9 (7.0)33.7 (6.8)32.1 (7.1)
Male, n (%)513 (69.7)318 (78.1)195 (59.3)
Symptom duration (years), mean (SD) [a]2.2 (1.7)2.5 (1.8)1.8 (1.6)
HLA-B27 positive, n (%)597 (81.1)354 (87.0)243 (73.9)
Sacroiliitis on imaging, n (%) [b]691 (93.9)401 (98.5)290 (88.1)
Prior anti-TNF treatment, n (%)31 (4.2)20 (4.9)11 (3.3)
Clinical Outcomes
%BLWk48 (NRI)BLWk48 (NRI)BLWk48 (NRI)
ASAS20-79.6-79.9-79.3
ASAS40-72.0-71.3-72.9
ASAS PR-57.3-55.8-59.3
BASDAI 50-71.7-71.3-72.3
Mean [c]BLWk48 (LOCF [c])BLWk48 (LOCF [c])BLWk48 (LOCF [c])
ASDAS3.71.63.81.63.61.5
HDA/VHDA,%98.524.7†98.525.898.523.2‡
ID, %-52.7†-52.6-52.9‡
CII, % [d]-76.5-78.6-73.9
MI, % [d]-56.3-58.7-53.2
BASDAI6.72.16.72.16.72.2
BASFI5.31.75.41.75.11.6
BASMI3.12.33.52.62.71.9
Nocturnal back pain6.91.87.01.86.81.8
Fatigue7.12.67.12.57.12.6
CRP (mg/L), median7.82.010.72.04.52.0
Baseline Characteristics and Clinical Outcomes
axSpA (n = 736)r-axSpA/AS (n = 407)nr-axSpA (n = 329)
Baseline Characteristics
Age (years), mean (SD)32.9 (7.0)33.7 (6.8)32.1 (7.1)
Male, n (%)513 (69.7)318 (78.1)195 (59.3)
Symptom duration (years), mean (SD) [a]2.2 (1.7)2.5 (1.8)1.8 (1.6)
HLA-B27 positive, n (%)597 (81.1)354 (87.0)243 (73.9)
Sacroiliitis on imaging, n (%) [b]691 (93.9)401 (98.5)290 (88.1)
Prior anti-TNF treatment, n (%)31 (4.2)20 (4.9)11 (3.3)
Clinical Outcomes
%BLWk48 (NRI)BLWk48 (NRI)BLWk48 (NRI)
ASAS20-79.6-79.9-79.3
ASAS40-72.0-71.3-72.9
ASAS PR-57.3-55.8-59.3
BASDAI 50-71.7-71.3-72.3
Mean [c]BLWk48 (LOCF [c])BLWk48 (LOCF [c])BLWk48 (LOCF [c])
ASDAS3.71.63.81.63.61.5
HDA/VHDA,%98.524.7†98.525.898.523.2‡
ID, %-52.7†-52.6-52.9‡
CII, % [d]-76.5-78.6-73.9
MI, % [d]-56.3-58.7-53.2
BASDAI6.72.16.72.16.72.2
BASFI5.31.75.41.75.11.6
BASMI3.12.33.52.62.71.9
Nocturnal back pain6.91.87.01.86.81.8
Fatigue7.12.67.12.57.12.6
CRP (mg/L), median7.82.010.72.04.52.0

Table Footnote: [a] Time since diagnosis of disease. [b] MRI/Xray. [c] Unless stated otherwise. [d] NRI. †n=734. ‡n=327. ASAS20/40: ≥20%/≥40% improvement in assessment of spondyloarthritis international society response criteria; PR: Partial Remission; ASDAS: Ankylosing Spondylitis Disease Activity Score; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; BASDAI 50: ≥50% improvement in BASDAI; BASFI: Bath Ankylosing Spondylitis Functional Index; BASMI: Bath Ankylosing Spondylitis Metrology Index; CII: Clinically Important Improvement (RFB ≥1.1); CRP: C-reactive protein; CZP: certolizumab pegol; HDA/VHDA: High/Very High Disease Activity (ASDAS≥2.1); ID: Inactive Disease (ASDAS <1.3); LOCF: last observation carried forward; MI: ASDAS Major Improvement (RFB ≥2.0); (n)r: (non)radiographic; NRI: non-responder imputation; RFB: reduction from baseline.

This abstract was previously submitted to Ghent 2018 and ACR 2018.

Disclosures: R. Landewe: Grants/research support; AbbVie, Ablynx, Amgen, AstraZeneca, Bristol-Myers Squibb, Centocor, Galapagos, GlaxoSmithKline, Jansen, Eli Lilly, Merck, Novartis, Pfizer, Roche, Schering and UCB Pharma. D. van der Heijde: Consultancies; AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Boehringer Ingelheim, Celgene, Daiichi, Eli Lilly, Galapagos, Gilead, Janssen, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi and UCB Pha. Other; Director of Imaging Rheumatology BV. M. Dougados: Consultancies; AbbVie, Eli Lilly, Merck, Novartis, Pfizer, UCB Pharma. Grants/research support; AbbVie, Eli Lilly, Merck, Novartis, Pfizer, UCB Pharma. X. Baraliakos: Consultancies; AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, Bristol-Myers Squibb, Celgene, Chugai, Janssen, MSD, Novartis, Pfizer and UCB Pharma. F. Van den Bosch: Consultancies; AbbVie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. Member of speakers’ bureau; AbbVie, Bristol Myers-Squibb, Celgene, Janssen, Merck, Novartis, Pfizer and UCB Pharma. K. Gaffney: Grants/research support; AbbVie, Celgene, MSD, Novartis, Pfizer and UCB Pharma. B. Hoepken: Other; Employee of UCB Pharma. K. Thomas: Other; Independent statistician contracted to UCB Pharma. L.S. Gensler: Grants/research support; UCB Pharma.

© The Author(s) 2019. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: [email protected]
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ePOSTERS (THURSDAY 2 MAY 2019) > SPONDYLARTHROPATHIES (INCLUDING PSORIATIC ARTHRITIS)
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