Maria Eugenia Suarez-Almazor

Objective: The objective of this study was to determine survival outcomes in older adults with axial spondyloarthritis (axSpA) and concomitant cancer. Methods: We conducted a population‐based study using Medicare claims data linked to Surveillance, Epidemiology, and End Results data to determine overall survival (OS) and cancer‐specific survival (CSS) in patients aged ≥66 years with in situ, localized, regional, or distant breast cancer (BC), prostate cancer (PCa), lung cancer (LC), or colorectal cancer (CRC), with and without axSpA, diagnosed January 2006 to December 2019, using International Classification of Diseases for Oncology, 3rd Edition (ICD‐O‐3) site and histology codes. Patients with axSpA were matched to two to five controls without axSpA using cancer type, age at cancer diagnosis, sex, stage, and year of cancer diagnosis. We censored OS and CSS at five years and estimated rates using Kaplan‐Meier analyses with log‐rank tests. Stratified Cox proportional hazard regression models were performed for each cancer type, with CSS analyzed under the competing risks framework. Results: We included 6,095 patients (2,061 BC, 1,988 PCa, 1,229 LC, 817 CRC) with axSpA and 30,386 controls. Mean ages ranged from 74 (BC, PCa, LC) to 77 (CRC) years. No statistically significant differences in OS or CSS rates were observed between patients with BC, PCa, or LC and axSpA compared to controls. Patients with CRC and axSpA had higher five‐year OS (adjusted hazard ratio [aHR] 0.78, 95% confidence interval [CI] 0.67–0.91, P = 0.002) and CSS (aHR 0.76, 95% CI 0.59–0.99, P = 0.04) compared to controls. Conclusion: Older patients with axSpA and BC, PCa, or LC had similar OS and CSS compared to controls. Among patients with CRC, axSpA was associated with higher OS and CSS.

Background: Melanoma is a highly immunogenic cancer and therefore, there have been concerns about the use of immunosuppressants in patients with this tumor and concomitant autoimmune disease. Our aim was to examine the survival of patients with rheumatoid arthritis (RA) and recently diagnosed melanoma, receiving disease-modifying antirheumatic drugs (DMARDs), including tumor necrosis factor alpha inhibitors (TNFi) and methotrexate (MTX). Methods: We utilized the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. We included patients aged ≥66 years with early-stage melanoma (2008- 2017) and RA. Patients were categorized by DMARD therapy within three years post-melanoma diagnosis: i) no DMARDs/conventional DMARDs other than MTX (control group), ii) MTX, and iii) TNFi, with or without MTX. Outcomes included overall survival (OS), cancer-specific survival (CSS), and recurrence-free survival (RFS). Cox proportional hazards regression models using propensity scores were used to analyze survival. Landmark analyses were conducted at 1, 2, and 3 years after diagnosis. Time-varying models were also performed. Findings: The cohort included 422 patients. For the 1-year landmark analysis, there were no statistical differences in OS between TNFi (HR 0.62, 95% CI 0.28-1.35) or MTX (HR 0.76, 95% CI 0.50-1.15) compared to controls. No statistical differences were observed in RFS for TNFi (HR 2.03, 95% CI 0.55-7.53) or MTX (HR 1.97, 95% CI 0.79-4.92). The 2-year landmark analyses revealed similar results. While there were no differences among groups in CSS, multivariable analysis was not performed because of the low frequency of events. Increasing glucocorticoid dose was associated with worse OS. Interpretation: We found no significant differences in OS, CSS, or RFS among RA patients with early-stage melanoma receiving MTX, TNFi alone or with MTX, and other conventional DMARDs or no DMARDs.

Background: Immune checkpoint inhibitor (ICI)-related inflammatory arthritis occurs in approximately 6% of ICI-treated patients, and is often long-lasting. The clinical presentation is heterogeneous, and often loosely resembles either rheumatoid arthritis (ICI-IA) with peripheral presentation, or polymyalgia rheumatica (ICI-PMR) with predominant bilateral shoulder and hip pain and stiffness. Our objective was to compare clinical features, immunosuppressive treatment, and cancer outcomes between ICI-IA and ICI-PMR. Methods: Data were extracted from the Rheumatology Adverse Events Due to Immunotherapy Observational Study multicenter prospective registry, regarding patients with rheumatologist-diagnosed ICI-IA or ICI-PMR and no preexisting primary IA/PMR. Clinical features were collected at the first visit in the registry. Multivariable logistic regression was used to compare second-line immunosuppressive drug utilization between groups. Kaplan-Meier curves were constructed to compare time of prednisone tapering to a dose of (1) 10 mg and (2) 5 mg from the baseline registry visit. Cox proportional hazard models were used to compare progression-free survival (PFS). Date of first cancer progression from arthritis onset was extracted based on documentation of imaging and/or pathology in the medical record. Patients with ICI-PMR were also compared with an independent cohort of patients with primary PMR. Results: We analyzed 490 patients: 418 with ICI-IA and 72 with ICI-PMR. Compared with patients with ICI-IA, patients with ICI-PMR were older (70 vs 63 years old, p<0.001), more likely to be male (p=0.034), had shorter onset after ICI initiation (87 vs 125 days, p=0.011) and had less peripheral synovitis (15% vs 72%, p<0.001). Time to a prednisone dose of 10 and 5 mg/day was comparable between groups. Patients with ICI-IA were more likely to receive a second-line immunosuppressive drug (OR 3.51 (95% CI 1.50 to 8.21, p=0.004)). PFS was comparable between groups. Compared with primary PMR (n=189), the sex ratio was inversed in ICI-PMR, but there was a similar proportion with peripheral arthritis (15%). Conclusions: Patients with ICI-IA were more likely to require a second-line immunosuppressive drug than patients with ICI-PMR, but PFS was the same. Future therapeutic clinical trials in ICI-IA/PMR should stratify patients according to phenotype.

This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To determine the benefits and harms of dose reduction or discontinuation of non-TNF biologic or targeted synthetic DMARDs in people with rheumatoid arthritis who are in remission or have low disease activity.

Objective: To evaluate the association between rheumatoid arthritis (RA) and mortality/treatment outcomes in patients with renal cell carcinoma (RCC), with attention to the impact of frailty on these associations.Methods: Retrospective cohort study examining patients with non-metastatic clear cell renal cell carcinoma (ccRCC) diagnosed between 2004-2017 via the SEER-Medicare database, stratified by RA and frailty status. Receipt of immunotherapy and cancer-related surgery were assessed and compared. Cox proportional hazards regression models evaluated the association between RA, frailty and mortality (all-cause and cancer-specific).Results: The population included 31,989 patients. Rates of cancer-related surgery were not significantly changed by RA status. No significant difference in immunotherapy administration based on RA status was observed (OR 0.81 [95% CI 0.59 – 1.12]). Frailty modified the relationship between RA and all-cause mortality (p = 0.01). RA was associated with higher all-cause mortality risk in non-frail patients (HR 1.15 [95% CI 1.03 – 1.29]), but no difference in risk in frail patients (HR 0.94 [95% CI 0.79 – 1.14]). Frailty was associated with a higher risk of cancer-specific mortality (HR 1.37 [95% CI 1.26 – 1.50]), while RA was not (HR 1.08 [95% CI 0.91 – 1.29]).Conclusion: RA was an independent risk factor for all-cause mortality in non-frail patients with non-metastatic ccRCC, but not in frail patients. Frailty interacts with RA on the risk of all-cause mortality in this population. The presence of frailty, but not RA, was an independent risk factor for cancer-specific mortality. RA did not appear to significantly impact the receipt of immunotherapy and cancer-related surgery.

Objective: Immune checkpoint inhibitors (ICIs) are effective cancer therapies but often cause serious immune‐related adverse events (irAEs). Patients with preexisting autoimmune diseases, including vasculitis, are excluded from trials. We aimed to evaluate the frequency, severity, and outcomes of vasculitis flares and irAEs in this population. Methods: We performed a retrospective review of cancer patients with prior vasculitis treated with ICIs at our institution and conducted a literature search for additional cases. Data included baseline features, vasculitis flares, irAEs, treatments, and tumor response. Results: Twenty‐five patients were identified (16 from our institution and 9 from the literature). Median age was 71 years; 13 (52%) were female. Vasculitis types included giant cell arteritis (GCA, n = 9), granulomatosis with polyangiitis (GPA, n = 8), eosinophilic granulomatosis with polyangiitis (EGPA, n = 2), leukocytoclastic vasculitis (n = 2), other cutaneous vasculitis (n = 2), and Henoch–Schönlein purpura and Behçet disease (1 each). Cancer types were diverse. Most patients received anti–programmed death‐1 monotherapy (n = 17). Eight patients (31%) experienced a vasculitis flare after ICI initiation (2/9 GCA, 4/8 GPA, 2/4 cutaneous vasculitis). Flares occurred after a median of seven weeks. Treatment included glucocorticoids in seven patients, combined with biologic or cytotoxic agents depending on vasculitis type. Seven of eight flares resolved, and four patients continued ICI therapy. Three additional patients developed de novo irAEs: severe hepatitis (n = 1), grade 3 colitis (n = 1), and grade 3 autoimmune hemolytic anemia (n = 1), all improving with treatment. One patient with GCA died due to a flare; no deaths were attributed to de novo irAEs. Overall, more than one‐third of patients achieved a favorable tumor response. Conclusion: Nearly one‐third of patients with preexisting vasculitis experienced a disease flare during ICI therapy, with one fatal case. For most, outcomes were favorable with effective flare management. Preexisting vasculitis should not be considered an absolute contraindication for cancer immunotherapy with ICI.

To apply grounded theory to generate a substantive theory that explains the roles adopted by caregivers or nearest support persons (CoNSP) and their added value when included as patient advocates in long-term outcomes research in rheumatoid arthritis (RA). A cross-national and multi-language qualitative research study, part of an ongoing project by the Outcome Measures in Rheumatology. The data collection was carried out from March 2018 to February 2019. Initially, four participants from the United States were selected. However, after examining the data we realized that adding the CoNSP as patient advocates might be useful to gain a wider understanding. Therefore, participants were contacted again and asked if they could identify a CoNSP to participate in the study. In addition, participants from Spain and Italy with their CoNSP were included. A total of 16 interviews were conducted (eight pairs composed of a person with RA and his/her CoNSP). To generate theory, the Glaser and Straus grounded theory approach was applied. We developed The Advocacy Effect Theory which is formed by the core category Vision which is a three-dimensional category: (i) Sharing the same viewpoint - people with RA and their CoNSP share the same viewpoint on the issues addressed, (ii) Expanding the viewpoint - people with RA and their CoNSP contributed information about the same issues, but the CoNSP provided more detailed insights on some of the topics previously shared by the person with RA, and (iii) A new viewpoint - the CoNSP provide original information about issues or topics that were not previously informed by the person with RA. This theory explains the roles of CoNSP and their added value when included as patient advocates in long-term outcomes research in RA. The Advocacy Effect Theory showed that CoNSP should be included in outcomes research as patient advocates. Their knowledge and contributions are dynamic, adding value by providing access to data that might not otherwise be accessible.

Background: Treatment of rheumatoid arthritis (RA) with biologic drugs in patients with cancer could potentially result in poor cancer outcomes. This study aimed to identify the beliefs, preferences, and informational needs of patients with RA and cancer regarding the harms, benefits, and uncertainties surrounding the use of RA therapy with respect to cancer. Methods: We interviewed 20 patients with RA and cancer recruited from a cancer center using a semi-structured guide. We explored patients’ discussions with physicians, beliefs, preferences about RA treatment, and decision-making issues. Using a deductive approach, patients’ responses were grouped according to the explored themes. Results: Fifteen (75%) patients were women; mean age was 59.9 years (standard deviation, 9.8). Patients discussed RA symptoms, adverse events, drug interactions, and discontinuation of RA treatment after cancer diagnosis; most felt their concerns were clarified after the discussion with their physicians. Some patients were concerned about the risk of cancer development or recurrence due to RA treatment; few were concerned about the interaction between RA and cancer treatment. Patients were concerned about the impact of cancer treatment on RA and potential immunosuppression. Patients relied on discussions with their physician and their own previous experiences to make decisions. Most patients would consider taking a drug for RA even when its impact on cancer is unknown. Patients wanted to receive information about drugs’ efficacy and adverse effects, drug interactions, impact of RA drugs on cancer, and costs. Conclusions: Our findings on informational needs, concerns, information delivery preferences, and desired level of involvement in the treatment-related decisions of patients with RA and cancer can facilitate the development of educational material that can help with shared decision-making in patients with RA and cancer. We identified important aspects related to the informational needs and concerns of patients with RA and cancer, including worries about not being able to receive RA treatment. Clinical trial number: Not applicable.