ACR Meeting Abstracts

ACR Meeting Abstracts

Abstract Number: 1398

Inflammatory Arthritis DMARD Adverse Effects Are Pervasive and Can Greatly Impact Quality of Life and Work and Social Roles: Initial Results from the Omeract Safety Working Group

Kathleen M. Andersen1, Ayano Kelly2, Anne Lyddiatt3, Clifton O. Bingham III4, Vivian P. Bykerk5, Marita Cross6, Adena Batterman7, Joan Westreich8, Lyn March9, Michelle Jones10, Beverly Shea11, Peter Tugwell12, Peter Brooks13, Lee S. Simon14, Robin Christensen15 and Susan J. Bartlett16, 1Department of Family Medicine, McGill University, Montreal, QC, Canada, 2Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, Australia, 3Musculoskeletal Group, Cochrane Collaboration, Hamilton, ON, Canada, 4Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 5Deptartment of Rheumatology, Hospital for Special Surgery, New York, NY, 6Institute of Bone and Joint Research–Kolling Institute, University of Sydney, Sydney, Australia, 7Social Work Programs, Hospital for Special Surgery, New York, NY, 8Department of Social Work Programs, Hospital for Special Surgery, New York, NY, 9Department of Rheumatology, Northern Clinical School, Institute of Bone and Joint Research, Kolling Institute, University of Sydney & Department of Rheumatology, Royal North Shore Hospital, St Leonards, Sydney, Australia, 10Johns Hopkins University School of Medicine, Baltimore, MD, 11University of Ottawa, Ottawa, ON, Canada, 12Center For Global Health, Institute of Population Hlth, Ottawa, ON, Canada, 13The University of Melbourne, Victoria, Australia, 14SDG LLC Consulting, West Newton, MA, 15Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg, Denmark, 16Department of Medicine, Division of ClinEpi, Rheumatology, Respirology, McGill University, Montreal, QC, Canada

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: , , ,

Session Information

Date: Monday, October 22, 2018

Title: Patient Outcomes, Preferences, and Attitudes Poster I: Patient-Reported Outcomes

Session Type: ACR Poster Session B

Session Time: 9:00AM-11:00AM

Background/Purpose: There is suboptimal reporting of adverse events (AE) in trials. The OMERACT Safety Working Group is developing a patient-centered AE collection and reporting approach to complement existing methods. Our initial goal was to hear from inflammatory arthritis (IA) patients about their perspectives on the benefit-harm balance of DMARDs.

Methods: Using an interview schedule, experienced interviewers conducted focus groups with IA patients in the US (n=14), Canada (n=10), and Australia (n=15) that were recorded, transcribed, and analyzed using a pragmatic thematic analysis approach based in grounded theory.

Results: Almost all patients reported AE ranging from mild to severe. The majority learn to live with AE, but some lives were completely changed.

“It was like I was domiciled on the toilet…I couldn’t go anywhere because you never knew when you needed a toilet.” (M 60s, CA)

“I’m on MTX and I’m finally friends with it. It took 2 years…I feel normal…except med day…But I’m happy to give up half a day…to have my life.” (F 20s, USA)

Many patients reported making adjustments to diet, sleep, and lifestyle to address AEs. Patients used different complementary and alternative approaches to self-manage their AEs but continued to live with ongoing disruption of function, self-confidence, work, and social roles due to AE.

“I feel like I can’t think anymore, and that really affects my work. And that’s my biggest problem. I can push through the pain and… fatigue, but I can’t think clearly. I just can’t do my job.” (F 30s USA)

The cumulative burden of AEs often led to patient-initiated discontinuation.

“I would open the fridge and look at the little brown envelope that the syringes were in. The nausea would start just looking at the envelope… I took it for a few more years, but I just couldn’t stand it anymore. It’s just like, get me off of this stuff.” (M 70s CA)

Underreporting was common due to embarrassment and uncertainty whether and how to discuss AEs. Providers were often perceived to react with disinterest, minimization, or irritation. Long-term safety was less concerning to patients with longer IA duration who had more symptoms and decreased function but greater treatment benefits despite repeated drug failures and serious AE.

Conclusion: The prevalence and importance of AEs, especially “nuisance AEs” is viewed differently by patients and clinicians. AEs negatively impacted function, participation, and QOL. Acceptability, tolerability and self-management of SEs varied among patients, by drug type and life stage, and in response to disrupted social and work roles. Patients learned to underreport SE when they perceived disinterest/minimization by clinicians.

Disclosure: K. M. Andersen, None; A. Kelly, Bristol Myers Squibb, 2; A. Lyddiatt, None; C. O. Bingham III, None; V. P. Bykerk, None; M. Cross, None; A. Batterman, None; J. Westreich, None; L. March, None; M. Jones, None; B. Shea, None; P. Tugwell, None; P. Brooks, None; L. S. Simon, None; R. Christensen, None; S. J. Bartlett, UCB, Inc., 5,Lilly, 5,Pfizer, Inc., 5,Novartis, 5.

To cite this abstract in AMA style:

Andersen KM, Kelly A, Lyddiatt A, Bingham III CO, Bykerk VP, Cross M, Batterman A, Westreich J, March L, Jones M, Shea B, Tugwell P, Brooks P, Simon LS, Christensen R, Bartlett SJ. Inflammatory Arthritis DMARD Adverse Effects Are Pervasive and Can Greatly Impact Quality of Life and Work and Social Roles: Initial Results from the Omeract Safety Working Group [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/inflammatory-arthritis-dmard-adverse-effects-are-pervasive-and-can-greatly-impact-quality-of-life-and-work-and-social-roles-initial-results-from-the-omeract-safety-working-group/. Accessed .

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