Session Information
Date: Monday, November 14, 2016
Title: Miscellaneous Rheumatic and Inflammatory Diseases - Poster II
Session Type: ACR Poster Session B
Session Time: 9:00AM-11:00AM
Background/Purpose: No study has compared the efficacy and the safety of biologics in a large relapsing polychondritis (RP) cohort. This is the aim of the present study.
Methods: We conducted a national multicenter retrospective study in France including adult patients treated with biologics for RP from 2001 until July, 2015. Data were recorded at the time of biologic exposure (T0), at 3 and 6 months, and then every 6 months. Follow-up ended at biologic discontinuation or at the date of last available data. Efficacy outcomes were the intention-to-treat rates of partial (PR, defined by clinical improvement with persistent disease activity) or complete response (CR, defined by no clinical activity) during the first 6 months of exposure, and the evolution of the corticosteroid (CS) doses between T0 and month 6 for patients having a >6-month exposure to each biologic. Adverse drug reactions (ADRs) were described. We also compared the persistence of biologics (excluding rituximab) through Kaplan-Meier curves and the reasons for discontinuation. Factors associated to a PR or CR during the first 6 months of exposure to first-line biologics were investigated using a multivariate logistic regression model.
Results: The cohort included 41 patients. Mean age was 46.9 ± 12.5 years and 53.6% were females. Median time from RP diagnosis to first-line biologic T0 was 26.5 months. All patients satisfied to McAdam, Damiani and Michet diagnostic criteria. All but 2 patients had an active disease at first biologic prescription. Reasons for biologic initiation were CS dependency (n=28), CS resistance (n=11) or ADR to previous treatments (n=3). First-line biologics were TNF inhibitors (n=30), tocilizumab (n=5), rituximab (n=4), anakinra and abatacept (n=1 each). Twenty-eight patients were exposed to at least 2 lines of biologics (because of insufficient efficacy in14, relapses in 8 or adverse drug reactions in 9). In total, 105 biologic prescriptions were recorded (TNF inhibitors, n=60; tocilizumab, n=17; anakinra, n=15; rituximab, n=7; abatacept, n=6). Outcomes are presented in Table 1. PR or CR rate during the first 6 months was 62.9% while CR rate was 19.0%. There was only a modest reduction in the median CS dose. ADRs were mostly infections (n=42) and reaction at site of injection for subcutaneous biologics (n=12). Persistence was comparable among biologic classes (p=0.77). Among TNF inhibitors, the highest persistence was observed on adalimumab and the lowest for etanercept (log-rank test: p=0.02). In multivariate analysis, the single factor associated to PR or CR during the first 6 months of exposure to first-line biologic treatment was a history of chondro-sternal inflammation (OR: 5.75; 95% CI: 1.27-26.07; p=0.02) and there was a trend for nasal or auricular inflammation at biologic initiation (OR: 4.30; 95% CI: 0.93-19.78, p=0.09).
Conclusion: Overall, biologics are an interesting option for RP treatment.
Biologics |
PR or CR at 6 months, n (%) |
CR at 6 months, n (%) |
Variation in CS dose at M6, mg PEQ, median (range) |
Follow-up, months, median (range) |
Discontinuation of biologic |
|||||
Overall |
Insufficient efficacy |
Loss of efficacy |
ADR |
Stable CR |
||||||
Overall (n=105) |
66 (62.9%) |
20 (19.0%) |
-5.0 (-72.5; +70.0) |
6.0 (0.1-80.8) |
77 (73.3%) |
36 (34.3%) |
19 (18.1%) |
22 (20.9%) |
1 |
|
TNF antagonists (n=60) |
38 (63.3%) |
14 (23.3%) |
-5 (-53; +70) |
6.0 (0.4-80.8) |
47 (78.3%) |
23 (38.3%) |
15 (25.0%) |
8 (13.3%) |
1 |
|
Infliximab (n=20) |
12 (60.0%) |
7 (35.0%) |
-5 (-50; +70) |
6.5 (0.4-80.8) |
16 (80.0%) |
7 (35.0%) |
6 (30.0%) |
3 (15.0%) |
0 |
|
Adalimumab (n=25) |
16 (64.0%) |
5 (20.0%) |
-7.5 (-53; +10) |
8.0 (0.4-71.7) |
18 (72.0%) |
6 (24.0%) |
7 (28.0%) |
5 (20.0%) |
1 |
|
Etanercept (n=11) |
8 (72.7%) |
0 |
-5 (-50; +0) |
5.5 (0.7-36.7) |
11 (100%) |
8 (72.7%) |
2 (18.2%) |
2 (18.2%) |
0 |
|
Golimumab (n=3) |
2 (66.7%) |
2 (66.7%) |
-20 |
3.8 (3.4-7.2) |
1 (33.3%) |
1 (33.3%) |
0 |
0 |
0 |
|
Certolizumab (n=1) |
0 |
0 |
– |
2.9 |
1 (100%) |
1 (100%) |
0 |
1 (100%) |
0 |
|
Tocilizumab (n=17) |
12 (70.6%) |
2 (11.8%) |
-1 (-72.5; +0) |
3.7 (0.4-36.2) |
10 (58.8%) |
4 (23.5%) |
2 (11.7%) |
4 (23.5%) |
0 |
|
Anakinra (n=15) |
8 (53.3%) |
2 (13.3%) |
-12.5 (-20; +0) |
2.6 (0.3-63.8) |
13 (86.7%) |
5 (33.3%) |
0 |
7 (46.7%) |
0 |
|
Rituximab (n=7) |
5 (71.4%) |
1 (14.3%) |
-3 (-30; +5) |
6.0 |
3 (42.8%) |
3 (42.8%) |
0 |
0 |
0 |
|
Abatacept (n=6) |
3 (50.0%) |
1 (16.7%) |
-16 (-40; +0) |
9.5 (0.1-37.1) |
6 (100%) |
3 (50.0%) |
2 (33.3%) |
1 (16.7%) |
0 |
Abbreviations: ADR, adverse drug reaction; CR, complete response; PR, partial response.
To cite this abstract in AMA style:
Moulis G, Pugnet G, Costedoat-Chalumeau N, Mathian A, Leroux G, Boutemy J, Bouillet L, Berthier S, Gaultier JB, Jeandel PY, Konaté A, Mékinian A, Solau-Gervais E, Terrier B, Wendling D, Garnier C, Cathebras P, Arnaud L, Cacoub P, Amoura Z, Piette JC, Arlet P, Palmaro A, Lapeyre-Mestre M, Sailler L. Efficacy and Safety of Biologics in Relapsing Polychondritis: A National Multicenter Study in France [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-biologics-in-relapsing-polychondritis-a-national-multicenter-study-in-france/. Accessed .« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-biologics-in-relapsing-polychondritis-a-national-multicenter-study-in-france/