Session Information
Date: Tuesday, November 15, 2016
Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy - Poster III
Session Type: ACR Poster Session C
Session Time: 9:00AM-11:00AM
Background/Purpose: Interstitial Lung Disease (ILD) is a severe extra-articular manifestation of rheumatoid arthritis (RA). A potential association of anti-TNFα drugs and conventional disease-modifying anti-rheumatic drugs (cDMARDs), such as methotrexate (MTX) and leflunomide (LFN), with the development of ILD in patients with RA has been suggested. The aim of our study was to assess the efficacy and safety of abatacept (ABA) in RA patients with ILD.
Methods: Multicenter study of RA patients with ILD treated with ABA. ILD was diagnosed by high-resolution computed tomography (HRCT). ABA was used at standard dose (10 mg/Kg/4 weeks i.v. or 125 mg/week s.c.). To assess the efficacy of ABA, we have analyzed the following variables: a) 1-point change in the degree of dyspnea according to the Modified Medical Research Council (MMRC); b) FVC improvement > 10%; and improvement > 10% in DLCO; c) radiological improvement in HRCT scan, and d)changes in the joint assessment measured by DAS28 score. Values were compared with baseline. Continuous variables by means of Wilcoxon´s signed rank test, and percentages by using the Chi-squared test or Fisher´s exact test as appropriate.
Results: We studied 55 patients (30 women/25 men) with ILD associated to RA; mean age 62.7±9.05 years. The median [IQR, 25th-75th] duration of RA to ILD diagnosis was 7 [2.33-14.00] years. Patients had received a mean of 2.36±1.9 DMARDs. RA was seropositive in 46 cases (83.6%). Besides HRCT, the diagnosis of ILD was confirmed by biopsy in 10 patients. ILD was considered as drug-related in 14 patients: MTX (n=7), etanercept (n=3), adalimumab (n=3) and certolizumab (n=1). ABA was prescribed as monotherapy (n=28) or combined with cDMARDs (n=27); these were LFN (n=7), LFN and cyclosporine (n=1), sulfasalazine (n=2), MTX (n=3), MTX and LFN (n=1), hydroxychloroquine (n=6), hydroxychloroquine and LFN (n=4), and azathioprine (n=3). The results are summarized in Table. A significant improvement of the dyspnea was observed. The patients who did not have dyspnea at ABA onset remained asymptomatic during the follow-up. FVC and HRCT showed a significant improvement between 6 and 12 months after the onset of therapy. DLCO remained stable in the majority of the patients. DAS28 also improved. After a follow-up of 8.29±3.82 months, the most important adverse effects were: respiratory infection (n=2), urinary infection (n=1) and infusion reaction (n=1). ABA had to be withdrawn in 7 patients: due to severe infection (n=2); inefficacy in polyarthritis (n=2), lack of pulmonary improvement (n=2) and infusion reaction (n=1).
Conclusion: ABA appears to be an effective and relatively safe therapy in RA patients with ILD. These promising results require to be confirmed in a prospective and randomized study. TABLE
Baseline |
3 months |
6 months |
12 months |
|
MMRC, – No change – Improvement – Worsening |
– – – |
81.8% 16.4%** 1.81% |
72.2% 25%** 2.7% |
62.9% 29.6%** 7.5%
|
FVC, – No change – Improvement – Worsening |
– – – |
84.6% 7.7% 7.7% |
53.3% 26.7%** 2.0% |
61.2% 27.7%* 11.1%
|
DLCO, – No change – Improvement – Worsening |
– – – |
58.4% 33.3%** 8.3% |
58.3% 16.7% 25.0% |
57.1% 28.6%** 14.3%
|
HRCT scan, – No change – Improvement – Worsening |
– – – |
66.7% 33.3%* 0.0% |
38.4% 46.2%** 15.4% |
35.7% 42.9%** 21.4%
|
DAS28, median [IQR] |
5.25 [4.13-5.85] |
2.61 [2.14-4.04]** |
3.10 [2.20-4.18]** |
3.55 [2.30-4.40]**
|
CRP (mg/dl), median [IQR] |
2.28 [1.08-6.95] |
1.70 [0.64-5.00] |
0.87 [0.50-5.40]** |
2.16 [1.43-7.69]
|
ESR (mm/1st h), median [IQR] |
33.0 [16.8-51.8] |
20.0 [10.0-44.0]** |
22.0 [9.0-38.0]* |
30.0 [12.5-53.0]** |
Comparisons refer to baseline values. * p< 0.05; **p< 0.01. In the case of qualitative variables only “improvement” was considered in the calculations.
To cite this abstract in AMA style:
Fernández-Díaz C, Loricera J, Castañeda S, Ojeda-Garcia C, Olivé A, Carreira PE, Perez Sandoval T, Retuerto M, Cervantes Pérez EC, Rodriguez-Muguruza S, Robles Flores BJ, Hernández-Cruz B, Urruticoechea A, Maiz Alonso O, Palma D, Arboleya L, Bonilla G, Hernández-Rodríguez Í, Delgado C, Expósito Molinero R, Ruibal Escribano A, Blanco Madrigal J, Bernal JA, Rodríguez-Gómez M, Vela Casasempere P, Alvarez-Rodriguez B, Fito Manteca MC, Ortiz Sanjuan F, Narváez J, Moreno MJ, Lopez-corbeto M, Mena-Vazquez N, Domínguez-Casas LC, Aguilera-Cros C, Mora-Cuesta V, Palmou-Fontana N, Gonzalez-Gay MA, Hernandez JL, Blanco R. Abatacept in Rheumatoid Arthritis with Interstitial Lung Disease: A Multicenter Study of 55 Patients [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/abatacept-in-rheumatoid-arthritis-with-interstitial-lung-disease-a-multicenter-study-of-55-patients/. Accessed .« Back to 2016 ACR/ARHP Annual Meeting
ACR Meeting Abstracts - https://acrabstracts.org/abstract/abatacept-in-rheumatoid-arthritis-with-interstitial-lung-disease-a-multicenter-study-of-55-patients/