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Glucagon-Like Peptide-1 Receptor Agonists and Chronic Cough
Kim, Ian , Vukkadala, Neelaysh , Barbu, Anca M. , Razura, Diego E. , Gallagher, Tyler J. , Li, Albert

Mayo Clinic

JAMA Otolaryngology–Head & Neck Surgery | November 26, 2025 | Volume: 152 | Issue: 2 | Pages: 163

10.1001/jamaoto.2025.4181 | PMID 41296333 Get It

Importance Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have become substantially more popular as a medication to treat obesity and type 2 diabetes (T2D). Despite their known association with gastroesophageal reflux disease and vagal nerve stimulation, the association between GLP-1RAs and chronic cough has not been previously studied. Objective To assess the clinical association between GLP-1RAs and chronic cough. Design, Setting, and Participants This large, multicenter cohort study used clinical records from a US-based collection of electronic medical record data from April 28, 2005, to April 15, 2025, from 70 health care organizations. Adults (≥18 years) with T2D and prescription of a GLP-1RA were identified. Additionally, groups with T2D and prescription of another second-line diabetes medication, including dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter 2 (SGLT2) inhibitors, and sulfonylureas were created. After propensity score matching for various demographic and clinical characteristics, adjusted hazard ratios (aHRs) and 95% CIs were calculated using Cox regression analyses to estimate the risk of new chronic cough or gastroesophageal reflux disease diagnosis. Exposure GLP-1RAs or other second-line diabetes medication. Main Outcomes and Measures Chronic cough. Results Cohorts included 427 555 individuals (mean [SD] age, 55.8 [13.8] years; 251 928 female individuals [58.9%]) with T2D who were prescribed a GLP-1RA and 1 614 495 individuals (mean [SD] age, 63.7 [13.3] years; 712 946 female individuals [44.4%]) with T2D who were prescribed another second-line diabetes medication. After propensity score matching, individuals prescribed a GLP-1RA had significantly increased risk of new chronic cough compared with individuals prescribed any non–GLP-1RA second-line medication (aHR, 1.12; 95% CI, 1.08-1.16), DPP-4 inhibitor (aHR, 1.18; 95% CI, 1.11-1.26), or sulfonylurea (aHR, 1.32; 95% CI, 1.24-1.40) but not compared with SLGT2 inhibitors (aHR, 1.03; 95% CI, 0.98-1.09). After removing patients with a previous diagnosis of gastroesophageal reflux disease from analysis, patients prescribed GLP-1RAs had significantly increased risk of chronic cough compared with those prescribed any non–GLP-1RA (aHR, 1.29; 95% CI, 1.17-1.42), DPP4 inhibitor (aHR, 1.36; 95% CI, 1.17-1.58), SGLT2 inhibitor (aHR, 1.14; 95% CI, 1.02-1.28), or sulfonylurea (aHR, 1.25; 95% CI, 1.09-1.42). Conclusions and Relevance This cohort study suggests an association between GLP-1RA use and chronic cough. Further research is needed to confirm the existence, strength, and mechanisms of this association.
Developing Global Gastrointestinal Care Capacity
Bryan, Matthew R , Bensen, Gordon P. , Wipper, Benjamin , Felicien, Shikama, Ingabire, Prosper, Rutaganda, Eric , Smith, Matthew , Laird, Rebecca, Makrauer, Frederick, Rubenberg, Lisa A, Chudy‐Onwugaje, Kenechukwu , Gardner, Timothy B. , Duerksen, Donald R. , Bensen, Steven P., Dusabejambo, Vincent , Dunleavy, Katie A. , Felicien, SHIKAMA, Makrauer, Frederick L., Bensen, Steve P.

Mayo Clinic

Journal of Clinical Gastroenterology | November 26, 2025 | Volume: 60 | Issue: 1 | Pages: 1-9

10.1097/mcg.0000000000002274 | PMID 41295906 Get It

Goals: Describe the establishment and expansion of a global gastrointestinal (GI) partnership and its impact on the advancement of GI care in Rwanda. Background: GI disease disproportionately affects low- and middle-income countries. In Rwanda, governmental and nonprofit efforts have made significant progress in expanding access to health care in the wake of the 1994 genocide; however, specialized care remains largely unrecognized or inaccessible. In response, the Rwanda Ministry of Health established a partnership with an international gastroenterology NGO to address this critical need. Study: We present summative data generated by this partnership. To inform future global GI programs, we provide lessons learned and details about Rwanda’s successful establishment of an in-country, self-sustainable, and locally governed gastroenterology training program. Results: From 2017 to 2023, the partnership expanded the number of clinical sites receiving care from 4 to 11. Total procedural volume increased from 244 to 1069. Most common presenting upper GI symptoms included dyspepsia, reflux, and emesis, while most common lower GI symptoms included hematochezia and constipation. Since 2017, this partnership has increased the number of faculty volunteering in Rwanda (and Rwandan clinicians studying in US academic medical centers), expanded its geographical reach, assisted in the creation of a GI fellowship, and enabled Rwanda to become an East African hub for medical education. Conclusions: Lessons learned across ethical, financial, leadership, cultural, and medical domains from the successful establishment and expansion of an international GI partnership in Rwanda provides invaluable insights to guide development of future models of health care in emerging economies.
Ambient listening implementation in primary care and changes in electronic health record documentation metrics: Pre–post study of an ambient listening tool
North, Frederick , Matthews, Marc R. , Iqbal, Asif , Post, Jason , Ebbert, Jon O. , Post, Jason A , Matthews, Marc R

Mayo Clinic

DIGITAL HEALTH | November 26, 2025 | Volume: 11 | Issue: No issue available | Pages: No page available

10.1177/20552076251403211 | PMID 41323090 Get It

Objective Ambient listening with subsequent artificial intelligence enabled medical record documentation is changing how physicians interact with the electronic health record (EHR). We studied primary care physician use, documentation time, and changes in note metrics associated with ambient listening technology. Methods We calculated the percentage of physicians adopting the ambient listening tool, Abridge. Note input contributed by Abridge was determined by the percentage of total characters in generated notes. Using the Epic EHR Signal metrics, we analyzed the change in note documentation time and note length for Abridge users before and after they implemented Abridge in their note generation process. Results The percentage of physicians using Abridge increased from 15% to 50% in 8 weeks. Adoption was also reflected in the percentage of the note attributable to the use of ambient listening technology. Note content generated by Abridge tripled, from 5% to 15% over the same 8 weeks. After Abridge adoption, 332 primary care physicians had a mean time of 4.16 minutes [confidence interval (CI) 95%; 3.86, 4.46] time in notes per note in a paired comparison to 5.11 minutes [CI 95%; 4.75, 5.47] per note prior to Abridge. Mean time saved per note after Abridge was 0.95 minutes [CI 95%; 0.48, 1.42, p < 0.0001], an 18.6% reduction in time. Mean note length for Abridge adopters increased by 238 characters [CI 95%; 89, 387, p < 0.0001] from a pre-implementation mean of 4404 characters per note (+5.4%). Conclusion Ambient listening had rapid uptake and widespread use by physicians in primary care. It was also associated with a significant decrease in time in notes.
Beyond Physical Frailty—the Value of Lifestyle and Social Frailty Factors to Predict Mortality and Hospitalization in COPD
Midthun, William R., Novotny, Paul J. , Benzo, Roberto P.

Mayo Clinic

Journal of Cardiopulmonary Rehabilitation and Prevention | November 26, 2025 | Volume: 46 | Issue: 1 | Pages: 28-34

10.1097/hcr.0000000000000991 | PMID 41295267 Get It

Purpose: Lifestyle and social frailty factors are a new focus in the multidimensional concept of frailty, as recent reports have found strong associations with negative health outcomes. We searched for specific social and lifestyle frailty factors independently associated with 5-year survival and the risk of hospitalization in patients with severe chronic obstructive pulmonary disease (COPD). Methods: We retrospectively analyzed questionnaire data from the National Emphysema Treatment Trial (NETT) and identified items related to the published definition of social frailty. Classification and Regression Tree, a machine learning method, was used to select variables most strongly associated with survival time or hospitalizations beyond 12 months of NETT study enrollment. Kaplan-Meier curves, log-rank tests, and Cox proportional hazards models were used to determine relationships between social/lifestyle variables and hospitalization and survival. Results: Four social and lifestyle frailty factors were significantly related to survival (impaired lifting, bathing and dressing, in-store shopping, and loneliness). Two social and lifestyle frailty factors were significantly related to risk of hospitalization (emotional distress and difficulty performing work or activities). A combination of 6 questions provided clinical phenotypes that were robustly and independently associated with mortality risk and hospitalization with hazard ratios that ranged from 2.4 to 11.2 and 2.2 to 3.5 for survival and hospitalization, respectively, after adjustment for age, sex, disease severity, and physical frailty. Conclusion: Lifestyle and social frailty factors that could be easily identified in practice may represent a novel approach to a multidimensional frailty assessment to predict survival and hospitalization in patients with severe COPD.
Phase-1 Cardiac Rehabilitation in Acute Heart Failure: Development of an Early Mobilization Algorithm Through Delphi Consensus
Satyamurthy, Akhila , Padmakumar, Ramachandran, Harikrishnan, Sivadasanpillai , Contractor, Aashish , Ozemek, Cemal , Bryant, Eryn, Ghisi, Gabriela Lima de Melo, Myers, Jonathan A. , Madan, Kushal , Supervía, Marta , Morris, Norman , Brubaker, Peter H. , Roos, Ronel , Hiser, Stephanie , Shanbhag, Vishal , Babu, Abraham Samuel , Babu, Abraham Samuel , Ramachandran, Padmakumar , Prabhu, Mukund Aravind , Jeemon, Panniyammakal , Ghisi, Gabriela Lima de Melo, Paramasivam, Ganesh , Myers, Jonathan, Hanekom, Susan D. , Yeo, Tee Joo

Mayo Clinic

Journal of Cardiopulmonary Rehabilitation and Prevention | November 26, 2025 | Volume: 46 | Issue: 1 | Pages: 58-66

10.1097/hcr.0000000000000978 | PMID 41294777 Get It

Purpose: Literature on early mobilization and exercise training in patients recovering from acute heart failure (AHF) is promising. However, there lacks uniformity in the time of initiation, exercise prescription, safety criteria, and termination criteria. Thus, the aim was to develop a mobilization algorithm for patients recovering from AHF. Methods: A modified web-based Delphi process was undertaken involving 15 panelists from across the globe. In Round 1, new variables, modifications to suggested variables, and agreement-disagreement within the panelists were obtained. In Round 2, agreement on a 5-point Likert scale was obtained. In Round 3, the algorithm was compiled, and excluded statements were discussed via web-based calls. The new variables were grouped into themes via an inductive process. The level of agreement and rating for each statement were analyzed using descriptive statistics, including frequency and percentages. We used Kappa statistics to examine the level of agreement between the panelists for each criterion. The consensus criterion was defined a priori as statements with a mean rating of ≥4 on the 5-point Likert scale by ≥70% of the panelists and Kendall’s coefficient of concordance ( W ) of ≥0.3 between panelists. Results: From Round 1, 54 new variables were obtained. More than two-thirds (118/170, 69%) of statements reached consensus and reported a fair level of agreement between panelists ( W ≥ 0.3). The final algorithm with all its criteria received a 100% (13/13) consensus. Conclusion: Physician-referral criteria, physiotherapy assessment process, exercise prescription, safety criteria, and termination criteria were formulated for early mobilization and exercise training for patients recovering from AHF.
Patient Characteristics and Outcomes of Cardiac Rehabilitation Following Thoracic Aortic Dissection Surgery: A Multicenter Retrospective Study
Heybati, Kiyan , Ochal, Domenic, Poudel, Keshav , Zuberi, Eric , Deng, Jiawen , Dineen, Elizabeth H. , Brahmbhatt, Pavan M., Daugherty, David H., Farres, Sam, Landolfo, Kevin, Bonikowske, Amanda R. , Mergo, Patricia J. , Shapiro, Brian P. , Deng, J , Taylor, Bryan J. , Brahmbhatt, Pavan M., Landolfo, Kevin , Thomas, Randal J.

Mayo Clinic

Journal of Cardiopulmonary Rehabilitation and Prevention | November 26, 2025 | Volume: 46 | Issue: 1 | Pages: 50-57

10.1097/hcr.0000000000000982 | PMID 41294921 Get It

Purpose: Despite the 2022 American Heart Association/American College of Cardiology guidelines recommending cardiac rehabilitation (CR) after aortic dissection repair, both patient participation in CR and the associated clinical outcomes remain poorly understood. Methods: Adults (≥18 years of age) discharged alive following thoracic aortic dissection surgery across the Mayo Clinic Enterprise (January 2012 to November 2022), with follow-up until May 2024, were included (IRB #24-001141). Data were presented using summary statistics and logistic regression modeling. Results: A total of 186 patients were referred; 37% were female, and the median age was 64 (51, 73) years. Dissections were classified as type A (43%), type B (18%), or a combination, and 55% had residual dissection. Over half (53%) did not start CR, with older age (aOR = 0.97: 95% CI, 0.94 - 0.99; P = .003), family history of aortic dissections and/or aneurysms (aOR = 0.17: 95% CI, 0.04 - 0.54; P = .005), and tobacco use (aOR = 0.35: 95% CI, 0.13 - 0.91; P = .037) being associated with lower odds of enrollment. Of the 87 who enrolled, 34 did so at a Mayo Clinic facility. There were no complications, with no difference in adverse outcomes. Among those with evaluations at graduation from CR (n = 21), quality of life (Dartmouth index 16 [14, 19] vs 25 [22, 30]; P = .002) and 6-minute walk distance (488 [375, 531] vs 302 [235, 398] m; P = .001) improved. Conclusions: Following thoracic aortic dissection repair, CR significantly improved quality of life and functional capacity without adverse events. Further work is needed to improve enrollment and establish data-driven safety margins for exercise.
Depression Symptoms in Patients With COPD: A Randomized Study of Home-Based Pulmonary Rehabilitation With Health Coaching
Benzo, Roberto, Roy, Madison, Benzo, M.V. , Clark, Matthew M. , Thomas, Benjamin, Benzo, Maria, Thomas, Benjamin

Mayo Clinic

Journal of Cardiopulmonary Rehabilitation and Prevention | November 26, 2025 | Volume: 46 | Issue: 2 | Pages: 125-131

10.1097/hcr.0000000000000990 | PMID 41295266 Get It

Purpose: Patients with chronic obstructive pulmonary disease (COPD) and symptoms of depression have increased health care utilization and lower quality of life. There is a knowledge gap regarding feasible and effective approaches for the management of depressive symptoms in patients with COPD. The objective of this randomized clinical trial sub-study is to determine whether 12-weeks of home-based pulmonary rehabilitation (PR) with health coaching is feasible and effective for improving depressive symptoms in patients with COPD. Methods: Patients with severe COPD and symptoms of depression (Patient Health Questionnaire-9 [PHQ-9] ≥5 points) randomized to the intervention (N = 90) or control (N = 78) groups in the parent study were included. The primary outcome of this sub-study was the 12-week change in the PHQ-9 score. Secondary outcomes included dyspnea, fatigue, emotions, and mastery (self-management) as measured by the Chronic Respiratory Questionnaire (CRQ) and daily physical activity and sleep measured by ActiGraph. Results: Home-based PR with health coaching was associated with improved measures of depression ( P = .07), dyspnea, fatigue, emotion, and mastery (self-management) ( P < .001). Being in the intervention group was associated with a higher odds of improving by the minimal clinically important difference on the PHQ-9 (OR = 2.10: 95% CI, 1.06-4.27), CRQ-Dyspnea (OR = 2.37: 95% CI, 1.11-5.26), CRQ-Fatigue (OR = 3.35: 95% CI, 1.59-7.35), CRQ-Emotions (OR = 4.59: 95% CI, 2.13-10.40), and CRQ-Mastery (OR = 3.36: 95% CI 1.60-7.28) after multivariable adjustment. The improvement in depression symptoms was maintained for 3 and 6 months after finishing the intervention. Conclusion: Home-based PR with health coaching is feasible and possibly effective in improving depressive symptoms and quality of life in patients with COPD and symptoms of depression.
Socioeconomic position and its effect on cardiovascular outcomes and mortality in patients with prostate cancer
Nahle, Tarek , Shah, Viraj , Kunhiraman, Harikrishnan Hyma , Afzal, Muhammad Umar , Riaz, Irbaz Bin , Agarwal, Neeraj , Swami, Umang , Rachoin, Jean-Sébastien , Weintraub, Neal L, Guha, Avirup , Makram, Omar M , Shah, Viraj R , Hyma Kunhiraman, Harikrishnan , Afzal, Muhammad Umar , Riaz, Irbaz B , Agarwal, Archana M , Swami, Umang , Rachoin, Jean-Sebastien , Guha, Avirup

Mayo Clinic

JNCI Cancer Spectrum | November 26, 2025 | Volume: 9 | Issue: 6 | Pages: No page available

10.1093/jncics/pkaf113 | PMID 41308174 Get It

Abstract Background Socioeconomic position (SEP) is a fundamental social determinant of health (SDoH) contributing to observed disparities in cancer and cardiovascular (CV) care among individuals with prostate cancer (PC). Understanding the influence of SEP on CV health is essential for addressing outcome inequities within this population. Methods We conducted a retrospective study utilizing Surveillance, Epidemiology, and End Results (SEER)-Medicare to evaluate CV outcomes in patients ≥65 years with PC from 2009 to 2017. We studied the impact of SEP on cardiovascular events (CVEs), cardiovascular mortality (CVm), PC-specific mortality (PCsm), and all-cause mortality. CVE, CVm, and PCsm were analyzed using competing risk models and all-cause mortality with Cox proportional hazards models. A subgroup analysis was performed in Non-Hispanic Black and Non-Hispanic White individuals. Results We included 141 242 patients of whom 76 844 were in high SEP areas (45.6%) and 64 398 in low SEP ones (54.4%). Both groups had a mean age of 72 years; patients in low SEP areas were 67.5% Non-Hispanic White, 34.4% having diabetes, 73.3% hypertension, and 67.7% dyslipidemia versus the high SEP group with 85.6% Non-Hispanic White, 30.4% diabetes, 69.9% hypertension, and 70.7% dyslipidemia. Patients in low SEP areas had higher risks of CVm (subdistribution hazard ratio [sHR] = 1.18, 95% CI = 1.12 to 1.25), PCsm (sHR = 1.12, 95% CI = 1.06 to 1.17), CVE (sHR = 1.07, 95% CI = 1.04 to 1.09), and all-cause mortality (HR 1.16, 95% CI = 1.13 to 1.20). Accentuated results were shown in the Non-Hispanic Black subgroup. Conclusion Adverse SEP plays a significant role in shaping outcomes among older patients with PC, contributing to elevated risks of adverse CV and survival outcomes.
Renal Replacement Therapy in Lupus Nephritis–Related End‐Stage Kidney Disease: A Systematic Review and Meta‐Analysis
Jorge, April , Bartels, Christie M. , Cunha, Joanne S., DeQuattro, Kimberly , Fava, Andrea , Garg, Shivani , Greco, Jessica , Cuéllar‐Gutiérrez, María C. , Iyer, Priyanka , Johannemann, Andrew, Kasturi, S.Psi. Taufik , Khawandi, Jana , Legge, Alexandra , Liang, Kelly V. , Lockwood, Megan M. , Sánchez-Rodríguez, Alain , Turgunbaev, Marat, Williams, Jessica N. , Sammaritano, Lisa R. , Bermas, Bonnie L. , Dall’Era, Maria , Hiraki, Linda T. , Turner, Amy S. , Jorge, April , Bartels, Christie M , DeQuattro, Kimberly , Fava, Andrea , Figueroa-Parra, Gabriel , Garg, Shivani , Cuéllar-Gutiérrez, María C, Kirou, Kyriakos A , Lockwood, Megan M , Sanchez-Rodriguez, Alain , Williams, Jessica N , Sammaritano, Lisa R , Askanase, Anca , Bermas, Bonnie , Duarte-García, Alí , Hiraki, Linda T , Rovin, Brad H , Turner, Amy S , Mustafa, Reem A , Kawtharany, Hassan , Azzam, Muayad , Figueroa‐Parra, Gabriel , Iyer, Priyanka, Kirou, Kyriakos A. , Duarte‐García, Alí , Rovin, Brad H. , Son, Mary Beth F.

Mayo Clinic

ACR Open Rheumatology | November 26, 2025 | Volume: 7 | Issue: 12 | Pages: No page available

10.1002/acr2.70121 | PMID 41294263 Get It

Objective To assess the impact of renal replacement therapy in people with lupus nephritis (LN)–associated end‐stage kidney disease (ESKD) and support the development of the 2024 American College of Rheumatology LN treatment guidelines. Methods We conducted a systematic literature review and meta‐analysis to address three Population, Intervention, Comparison, and Outcome (PICO) questions related to renal replacement therapy for ESKD due to LN, including comparisons of kidney transplant versus dialysis, hemodialysis versus peritoneal dialysis, and preemptive kidney transplant versus no preemptive kidney transplant. Outcomes of interest included mortality, cardiovascular (CV) events, infections, lupus flares, disease‐related damage, graft failure, and quality of life. We conducted a meta‐analysis and analyzed hazard ratios for time‐to‐event analyses and risk ratios for dichotomous outcomes, as well as absolute risk estimates. Results Sixteen comparative observational studies addressed at least one of the three PICO questions. Kidney transplant was found to reduce the risks of all‐cause mortality, CV mortality, infection‐related mortality, and CV events compared with dialysis (high certainty). Dialysis modality (peritoneal vs hemodialysis) was not associated with mortality (high certainty) or with other outcomes of infection, CV complications, and systemic lupus erythematosus flares (low certainty). Preemptive kidney transplant was associated with lower risks of graft failure and mortality (low certainty). Conclusion This systematic review identified improved outcomes with kidney transplant versus dialysis for people with LN‐associated ESKD and potential benefits of preemptive kidney transplant. This evidence supports the use of kidney transplant as a preferred renal replacement therapy for people with LN‐ESKD.
Combining Pirfenidone With Mycophenolate Mofetil for Systemic Sclerosis–Related Interstitial Lung Disease (Scleroderma Lung Study III ): An Investigator‐Initiated, Multicenter, Randomized, Double‐Blind, Pl
Khanna, Dinesh , Spino, Cathie , Kleerup, Eric C., Harui, Airi, Ibrahim, Grace, Kim, Grace Hyun J. , Huang, Suiyuan, McLain, Richard, Tu, Yi‐Hsuan, Steen, Virginia , Weigt, S. Samuel , Lee, Joyce , Fischer, Aryeh , Scholand, Mary Beth , Gordon, Jessica , Dellaripa, Paul F. , Rosas, Iván O. , Hunninghake, Gary M. , Trojanowski, Marcin A. , Dematte, Jane E. , Hsu, Vivien , Domsic, Robyn T. , Raghu, Ganesh , Boente, R. , Roth, Michael D. , Investigators, the Scleroderma Lung Study III, Kim, Grace Hyun J , Nagaraja, Vivek , Silver, Richard M. , Gordon, Jessica K , Dellaripa, Paul F , Domsic, Robyn T , Mayes, Maureen D , Boente, Ryan D , Roth, Michael D , Khanna, Dinesh , Lee, Joyce S , Hunninghake, Gary M , Tashkin, Donald P. , Bernstein, Elana J. , Goldin, Jonathan , Nagaraja, Vivek , Simms, Robert W. , Mayes, Maureen D. , Investigators, the Scleroderma Lung Study III

Mayo Clinic

ACR Open Rheumatology | November 26, 2025 | Volume: 7 | Issue: 12 | Pages: No page available

10.1002/acr2.70126 | PMID 41294296 Get It

Objective Mycophenolate mofetil (MMF) can stabilize or improve lung function in systemic sclerosis–related interstitial lung disease (SSc‐ILD). We hypothesized that combining MMF with pirfenidone (PFD) would produce a significantly more rapid and/or greater improvement in lung function. Methods A randomized (1:1), double‐blind, placebo (PLA)‐controlled phase 2 trial was conducted in SSc‐ILD in which patients received PFD or PLA (801 mg three times daily) along with MMF (1,500 mg twice daily) for 18 months. The primary outcome was change in percent predicted forced vital capacity (FVC‐%). Linear mixed‐effects models assessed treatment differences in a modified intention‐to‐treat population. Results Only fifty‐one of 150 intended subjects (34%) were randomized (MMF+PLA, n = 24; MMF+PFD, n = 27). The FVC‐% improved from baseline to 18 months by 2.24 ± 1.35 (least‐squares mean [LSM] ± SEM) in the MMF+PLA group and 2.09 ± 1.28 in the MMF+PFD group (LSM treatment difference −0.14; P = 0.93). Median time to achieve a ≥3% improvement in FVC‐% was numerically faster in the MMF+PFD versus MMF+PLA group (12.3 vs 17.8 months, respectively), but the difference was not significant ( P = 0.33). For secondary outcomes, only the change over 18 months in the Patient‐Reported Outcomes Measurement Information System 29‐item physical function score, favoring MMF+PFD, reached statistical significance ( P = 0.04). Although other related patient‐reported outcomes (PROs) numerically favored the MMF+PFD group, as did quantitative high‐resolution computed tomography measures of ILD, the differences between groups did not reach statistical significance. Early withdrawals from study medication and adverse events of special interest were numerically greater with MMF+PFD (n = 8 vs 2 and n = 20 vs 7, respectively). Conclusion In this underpowered study, there was no statistically significant treatment difference in overall change in FVC‐% between groups. MMF+PFD was not as well tolerated as MMF+PLA.