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Efficacy and Safety of Rituximab in Autoimmune Disease-Associated Interstitial Lung Disease: A Prospective Cohort Study.

ABSTRACT: To analyze the efficacy and safety of rituximab (RTX) in connective tissue disease associated with interstitial lung disease (CTD-ILD). We performed a multicenter, prospective, observational study of patients with CTD-ILD receiving rituximab between 2015 and 2020. The patients were assessed using high-resolution computed tomography and pulmonary function tests at baseline, at 12 months, and at the end of follow-up. The main outcome measure at the end of follow-up was forced vital capacity (FVC) > 10% or diffusing capacity of the lungs for carbon monoxide (DLCO) > 15% and radiological progression or death. We recorded clinical characteristics, time to initiation of RTX, concomitant treatment, infections, and hospitalization. A Cox regression analysis was performed to identify factors associated with worsening ILD. We included 37 patients with CTD-ILD treated with RTX for a median (IQR) of 38.2 (17.7-69.0) months. At the end of the follow-up, disease had improved or stabilized in 23 patients (62.1%) and worsened in seven (18.9%); seven patients (18.9%) died. No significant decline was observed in median FVC (72.2 vs. 70.8; p = 0.530) or DLCO (55.9 vs. 52.2; p = 0.100). The multivariate analysis showed the independent predictors for worsening of CTD-ILD to be baseline DLCO (OR (95% CI), 0.904 (0.8-0.9); p = 0.015), time to initiation of RTX (1.01 (1.001-1.02); p = 0.029), and mycophenolate (0.202 (0.04-0.8); p = 0.034). Only 28 of the 37 patients (75.6%) were still undergoing treatment with RTX: two patients (5.4%) stopped treatment due to adverse events and seven patients (18.9%) died owing to progression of ILD and superinfection. Lung function improved or stabilized in more than half of patients with CTD-ILD treated with RTX. Early treatment and combination with mycophenolate could reduce the risk of progression of ILD.

SUBMITTER: Mena-Vazquez N

PROVIDER: S-EPMC8879100 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature

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Efficacy and Safety of Rituximab in Autoimmune Disease-Associated Interstitial Lung Disease: A Prospective Cohort Study.

Mena-Vázquez Natalia N Redondo-Rodríguez Rocío R Rojas-Gimenez Marta M Romero-Barco Carmen María CM Manrique-Arija Sara S Ortega-Castro Rafaela R Hidalgo Conde Ana A Arnedo Díez de Los Ríos Rocío R Cabrera César Eva E Espildora Francisco F Aguilar-Hurtado María Carmen MC Añón-Oñate Isabel I Pérez-Albaladejo Lorena L Abarca-Costalago Manuel M Ureña-Garnica Inmaculada I Velloso-Feijoo Maria Luisa ML Irigoyen-Oyarzábal Maria Victoria MV Fernández-Nebro Antonio A

Journal of clinical medicine 20220210 4

<h4>Objectives</h4>To analyze the efficacy and safety of rituximab (RTX) in connective tissue disease associated with interstitial lung disease (CTD-ILD).<h4>Methods</h4>We performed a multicenter, prospective, observational study of patients with CTD-ILD receiving rituximab between 2015 and 2020. The patients were assessed using high-resolution computed tomography and pulmonary function tests at baseline, at 12 months, and at the end of follow-up. The main outcome measure at the end of follow-u ...[more]

PMID: 35207203

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Project description:ObjectiveInterstitial lung disease (ILD) is a common manifestation of connective tissue disease (CTD) that manifests as several subtypes with significant differences in prognosis. It is necessary to evaluate the efficacy and safety of pirfenidone (PFD) combined with immunosuppressant (IS) in the treatment of CTD-ILD.MethodsA total of 111 patients with CTD-ILD were enrolled, including those with systemic sclerosis (SSc), inflammatory myopathy (IIM), rheumatoid arthritis (RA), and other CTDs (such as systemic lupus erythematosus, primary Sjogren's syndrome, and undifferentiated CTD). After evaluation of the high-resolution computed tomography (HRCT), pulmonary function (PF), and basic disease activity, patients either were or were not prescribed PFD and were followed up regularly for 24 weeks.ResultsAfter 24 weeks of treatment, predicted forced vital capacity (FVC%) in the SSc-PFD group had improved by 6.60%, whereas this value was 0.55% in patients with SSc-no-PFD. The elevation in FVC% was also significant in IIM-PFD over the IIM-no-PFD controls (7.50 vs. 1.00%). The predicted diffusing capacity for carbon monoxide (DLCo%) of RA-PFD was enhanced by 7.40%, whereas that of RA-no-PFD decreased by 5.50%. When performing a subtype analysis of HRCT images, the change in FVC% among patients with SSc with a tendency toward usual interstitial pneumonia (UIP) was higher in those given PFD (SSc-PFD-UIP) than the no-PFD group (8.05 vs. -3.20%). However, in IIM patients with a non-UIP tendency, PFD displayed better therapeutic effects than the control (10.50 vs. 1.00%). DLCo% improved significantly in patients with the PFD-treated RA-non-UIP subtype compared with the patients with no-PFD (10.40 vs. -4.45%). Dichotomizing the patients around a baseline FVC% or DLCo% value of 70%, the PFD arm had a more improved FVC% than the no-PFD arm within the high-baseline-FVC% subgroups of patients with SSc and IIM (6.60 vs. 0.10%, 6.30 vs. 1.10%). In patients with RA-PFD, DLCo% showed a significant increase in the subgroup with low baseline DLCo% compared to that in patients with RA-no-PFD (7.40 vs. -6.60%).ConclusionThe response of PF to PFD varied between CTD-ILD subsets. Patients with SSc and IIM showed obvious improvements in FVC%, especially patients with SSc-UIP and IIM-non-UIP. In RA, the subsets of patients with non-UIP and a lower baseline DLCo% most benefited from PFD.

Project description:BackgroundManaging malignant pleural effusion (MPE) with pleurodesis is essential for symptom relief and minimizing the need for repeated thoracentesis. Interstitial lung disease (ILD) is one of the most common complications associated with advanced lung cancer. However, the efficacy and safety of pleurodesis for MPE secondary to lung cancer with ILD remains unclear. This study aimed to evaluate the efficacy and safety of pleurodesis in this population.MethodsThis study was a single-center retrospective analysis. The cases of pleurodesis in patients with MPE secondary to lung cancer complicated with ILD at Nippon Medical School Hospital (Tokyo, Japan) between January 2010 and December 2022 were included.ResultsOf the 26 lung cancer patients with ILD who underwent pleurodesis were analyzed. Fourteen patients received talc and 12 patients received minocycline, respectively. Talc was used in 10 out of 14 patients with drug-induced ILD and radiation-induced lung injury (RILI). In contrast, minocycline was used in 10 out of 12 patients with idiopathic interstitial pneumonias (IIPs). One month after pleurodesis, the efficacy for pleural adhesions was 64.3% and 50.0% in the talc and minocycline groups. The presence of a partially expanded lung before pleurodesis was a predictive factor for failure [odds ratio: 7.00, 95% confidence interval (CI): 1.20-40.83, P=0.04]. When excluding the patients presenting partially expanded lung, the efficacy rate was 77.8% and 71.4% in the talc and minocycline groups. One case of grade 5 acute respiratory distress syndrome (ARDS) was observed in each group. All cases developing ARDS had been treated with systemic prednisolone against ILDs presenting ground glass opacity and consolidation within 6 months before pleurodesis.ConclusionsPleurodesis is considered to be one of the treatment options against MPE in patients with ILD. However, two cases of ARDS were observed; thus, clinicians should carefully consider the indication of pleurodesis in the patients who had the recent onset of ILD and were treated with systemic prednisolone.

Project description:Background: Interstitial lung diseases (ILDs) are often associated with rheumatic diseases. Their early diagnosis and management are not only difficult, but also crucial, because they are associated with major morbidity and mortality and can be the first cause of death in autoimmune rheumatic diseases (ARDs). Objectives: By using methodologies, such as Nominal Group Technique (NGT) and Delphi Survey, the aims of this study were (1) to measure consensus between pulmonologists, radiologists, and rheumatologists experienced in the management of ARD-ILD; (2) to highlight the importance of a multidisciplinary approach; and (3) to provide clinicians with a practical tool aimed at improving the prompt recognition and follow-up of ILD associated with ARDs and of any possible rheumatic conditions underlying ILD. Results: During the NGT round, the Steering Committee defined 57 statements to be used in the Delphi survey. A total of 78 experts participated in the Delphi survey, namely 28 pulmonologists, 33 rheumatologists, and 17 radiologists. During this round, consensus on agreement was reached in 47 statements, while disagreement was not reached in any statements. A secondary questionnaire was drafted by the Steering Committee to obtain clearer indications on ILD-ARD "red-flags" and follow-up. Delphi Panelists took part also in the second-questionnaire survey. Answers from both surveys were used to draft two checklists of "red flags" sign or symptom suggestive of ILD and ARD, respectively, and two checklists on identification and monitoring of rheumatoid arthritis (RA) and systemic sclerosis (SSc) ILD. Limitations: This study is a consensus work, which cannot produce empiric data, and is limited to the Italian scenario. Conclusions: This work showed a high level of agreement, but also shows some divergent opinions between different experts. This underlines the importance of a multidisciplinary approach. Eventually, we believe the drafted checklists can help clinicians in the diagnosis and follow-up of ILD-ARD.

Project description:ObjectiveTo evaluate rheumatoid arthritis (RA) disease activity and risk of RA-associated interstitial lung disease (RA-ILD).MethodsWe investigated disease activity and risk of RA-ILD using the Brigham RA Sequential Study (BRASS, 2003-2016). All patients were diagnosed as having RA according to accepted criteria. Disease Activity Scores in 28 joints (DAS28) and covariate data were measured prospectively at annual study visits. Diagnosis of RA-ILD was determined by review of images from clinically indicated chest computed tomography scans. We analyzed patients without RA-ILD at baseline. We used Cox regression to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) for RA-ILD, using annually updated DAS28 data, with adjustment for known RA-ILD risk factors (age, sex, smoking status, RA duration, and serologic status). We performed alternative analyses that did not censor at the time of missing DAS28 data and included adjustment for use of methotrexate, use of glucocorticoids, presence of bone erosions, and presence of rheumatoid nodules.ResultsAmong 1,419 participants, the mean ± SD age was 55.8 ± 14.2 years, and 68.6% were seropositive for either cyclic citrullinated peptide or rheumatoid factor. We identified 85 incident cases of RA-ILD during a mean ± SD follow-up duration of 8.9 ± 4.2 years per patient. The moderate/high disease activity group had a multivariable HR of 2.22 (95% CI 1.28-3.82) for RA-ILD compared to the remission/low disease activity group. Risk of RA-ILD increased across disease activity categories: multivariable HR 1.00 (reference) for remission, 1.41 (95% CI 0.61-3.28) for low disease activity, 2.08 (95% CI 1.06-4.05) for moderate disease activity, and 3.48 (95% CI 1.64-7.38) for high disease activity (P for trend = 0.001). For each unit increase in the DAS28, the risk of RA-ILD increased by 35% (95% CI 14-60%). Results were similar in analyses that included follow-up for missing DAS28 data and with adjustment for use of methotrexate, use of glucocorticoids, presence of bone erosions, or presence of rheumatoid nodules.ConclusionActive articular RA was associated with an increased risk of developing RA-ILD. These results suggest that decreasing systemic inflammation may alter the natural history of RA-ILD development.

Project description:BackgroundTo identify risk factors for progression, acute exacerbation (AE), and the development of rapidly progressive interstitial lung disease (RP-ILD) in Systemic autoimmune rheumatic disease-associated interstitial lung disease (SARD-ILD).MethodsWe systematically searched PubMed, EMBASE, Scopus, the Cochrane Library, and Web of Science databases to identify eligible cohort studies up until January 01, 2024. Two reviewers independently screened the literature and extracted data. We employed the Newcastle-Ottawa Scale (NOS) to assess study quality and performed meta-analyses using STATA software.ResultsThis review included 50 studies. For progression, 28 studies were included, four significant risk factors were identified: male (OR = 1.97, 95% CI 1.26-3.08, p < 0.001), UIP patterns on HRCT (OR = 1.94, 95% CI 1.48-2.54, p < 0.001), extensive lung involvement (OR = 2.15, 95% CI 1.66-2.80, p < 0.001), and age (OR = 1.07, 95% CI 1.05-1.10, p < 0.001); and 11 potential risk factors. Seven studies were included in AE, and three potential risk factors were highlighted: FVC, UIP patterns on HRCT, and smoking history. In RP-ILD, 15 studies were included. Three risk factors were determined: High CRP (OR = 2.45, 95% CI 1.87-3.21, p < 0.001), Ro-52 positivity (OR = 5.35, 95% CI 3.46-8.29, p < 0.001), and MDA5 antibodies (OR = 2.09, 95% CI 1.47-2.95, p < 0.001); along with 10 potential risk factors.ConclusionOur meta-analysis identified male sex, UIP pattern on HRCT, extensive lung involvement, and advanced age as significant risk factors for the progression of SARD-ILD. High CRP, Ro-52 positivity, and MDA5 antibodies were significant risk factors for developing of RP-ILD in patients with IIM. We also discovered several potential risk factors that may be associated with the progression of SARD-ILD and acute exacerbation, as well as the occurrence of RP-ILD in IIM patients.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/.

Dataset Information

Efficacy and Safety of Rituximab in Autoimmune Disease-Associated Interstitial Lung Disease: A Prospective Cohort Study.

Publications

Efficacy and Safety of Rituximab in Autoimmune Disease-Associated Interstitial Lung Disease: A Prospective Cohort Study.

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