Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: There’s scant data of CertolizumabPEGol (CZP) in clinical practice. Study goal: assess efficacy and safety of CZP in RA patients at 3, 6,12-month (m), and clinical / serological variables that predict 12-m clinical CZP response.
Methods: Observational, retrospective study of RA patients (ACR 2010), 35 sites in Spain. Patients on CZP, either anti TNF naïve / after other Biological Therapies (BT) failure. Study approved by a local Ethics Committee. Efficacy variables: Tender Joint Count (TJC) and Swollen Joint Count (SJC) reductions, European League against Rheumatism (EULAR) Response, Simplified Disease Activity Index (SDAI) response, steroids dose, CRP, ESR. Safety variables: discontinuation due to side effects. Statistical analysis: SPSS v19.0. Comparative: Mann Whitney / Chi-square tests. Longitudinal: Friedman Cochran’s test. Logistic regression analyses performed.
Results: 168 patients: 79.2% women, mean age 54.5 (±13.2), mean disease time 7.5 (±7.3), prior DMARD (25.6% none; 32.1% 1, 42.3% ≥2): MTX 55.4%, leflunomide 36.9%, gold 25.6%, SSZ 11.3%, HCQ 10.7%. Mean number (nr) prior DMARD: 1.4 (±1.2). Prior BT (54.2% none, 28.6% 1, 17.2% ≥2): etanercept 23.8%, adalimumab 19.0%, infliximab 16.1%, rituximab 6.5%, tocilizumab 5.4%, abatacept 4.2%, golimumab 3.0%. Mean nr prior BT 0.8 (±1.1). Mean time on CZP 9.8 m (±3.4), 93.5% induction dose. Concomitant treatment: 11.9% oral steroids, 24.4% DMARD, 50.0% DMARD + steroids (69.6% 1 DMARD, 4.8% 2 DMARDs).
Table 1:Basal, 3-m, 6-m, 12-m clinical variables
|
|
Basal |
3-m |
6-m |
12-m |
P value |
|
RF |
70.8% (mean RF: 124.2 ±183.2) |
|
|
|
|
|
Anti-Cyclic citrulinated Protein (CCP) |
59.8% (mean CCP:275.1 ±454.9) |
|
|
|
|
|
CRP |
9.0 (±12.7) |
5.7 (±11.7) |
4.7 (±9.9) |
4.6 (±9.9) |
<0.001 |
|
ESR |
32.3 (±25.3) |
25.7 (±21.2) |
23.7 (±21.9) |
23.5 (±19.9) |
<0.001 |
|
TJC |
8.0 (±5.2) |
4.7 (±5.3) |
3.6 (±5.0) |
3.3(±5.2) |
<0.001 |
|
SJC |
6.0 (±4.5) |
3.1 (±4.2) |
2.1 (±3.7) |
2.2 (±3.9) |
<0.001 |
|
Disease Activity Score (DAS28) |
5.1 (±1.3) |
4.0 (±1.6) |
3.5 (±1.7) |
3.4 (±1.7) |
<0.001 |
|
DAS28 remission |
4.2% |
23.8% |
35.7% |
44.0% |
|
|
EULAR Moderate /Good Response |
|
19.6% / 29.8% |
27.4% /38.7% |
25.0% / 46.4% |
|
|
SDAI |
35.8 (±18.1) |
22.1 (±20.7) |
17.8 (±19.3) |
17.1 (±19.6) |
<0.001 |
|
Steroids (mg) |
8.8 (±6.9) |
6.6 (±5.7) |
5.7 (±5.7) |
4.8 (±5.2) |
<0.001 |
19 patients had mild side-effects, 6 at 3-m (1 varicella zoster reactivation), 8 at 6-m (1 mild respiratory tract infection, that led to CZP withdrawn), 5 at 12-m (1 infectious otitis). 48 withdrawn (28.6%): 31 lack efficacy, 15 intolerance, 2 other causes, 11.9% 3-m and 16.7% 6-m. 120 patients (71.4%) went on CZP at 12-m visit.
Looking responders versus non responders for DAS28/EULAR Response/SDAI we saw some predictors of response (p<0.05): lower nr of prior DMARD / BT; higher CRP, ESR, TJC, SJC, DAS28, SDAI. No differences in BT-naive / monotherapy
Conclusion: CZP showed clear benefit in severe refractory to DMARD / BT RA patients with a significant reduction of CRP, ESR, TJC, SJC, DAS28. 75% patients achieved moderate/good EULAR response, either RF/antiCCP (+) or (-). 12-m predictors of response: CRP, ESR, nr of prior DMARD / BT, TJC, SJC, DAS28, SDAI. CZP was well tolerated, no serious side effects. On clinical practice, CZP showed benefit in 71% of RA after 12-m, even in a 45.8% of patients with prior antiTNF
Disclosure:
V. Torrente-Segarra,
None;
A. Urruticoechea,
None;
H. Corominas,
None;
A. Sánchez,
None;
J. V. Tovar,
None;
A. Muñoz,
None;
A. Martínez,
None;
J. A. González,
None;
M. Fernández,
None;
N. Vázquez on behalf of RENACER Study Group,
None.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/renacer-study-assessment-of-12-month-efficacy-and-safety-of-168-certolizumabpegol-rheumatoid-arthritis-treated-patients-from-a-multicenter-retrospective-national-study-in-spain/