Chronic pain

Osteoarthritis (OA) and Chronic Low Back Pain (CLBP) are two of the most common chronic pain conditions worldwide. Both conditions are associated with substantial humanistic and socioeconomic burdens. Pharmacologic therapy for OA and CLBP often includes non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, typically in a step-up approach.

There is an unmet need for novel, nonopioid treatments for the management of chronic pain conditions because available therapies often have limited effect or work for only some patients. In addition, there are major risks associated with NSAIDS and opioids that limit their usefulness, particularly for patients with comorbidities who are not appropriate candidates for NSAID and/or opioid treatment.

Patient preferences for pharmacologic treatments for chronic OA pain and CLBP have been formally measured; however, existing studies are limited in their ability to provide results that can inform the benefit-risk tradeoffs that patients are willing to make among NSAIDs, opioids, and potential alternative forms of systemic pharmacologic treatment.

To quantify patients’ perspectives of the value of alternatives to NSAIDs and opioids, Pfizer and Lilly conducted a DCE in patients with OA only, CLBP only, and concurrent OA and CLBP in the US. The patient samples included difficult-to-treat patients with moderate-to-severe pain due to knee and hip OA or CLBP who have taken or tried three or more classes of pain treatment in the past 2 years, for whom NSAIDs are contraindicated, or who are intolerant of NSAIDs or unwilling to take opioids.

To quantify patients’ perspectives of the value of tanezumab compared with other products, Pfizer and Lilly were interested in conducting a DCE in patients with OA only, CLBP only, and concurrent OA and CLBP in the US. Specifically, Pfizer and Lilly hoped to quantify patient preferences for the characteristics of tanezumab relative to those of NSAIDs, opioids, and other NGF-inhibitor products. Separate preference studies were conducted in the US and UK using the same survey instrument.

FACT SHEET

Therapeutic area: Chronic pain

Study led by: Pfizer, Eli Lily

PREFER leads team: Leo Russo, Kristin Bullok

MPLC decision point of interest: Pre-approval and late development

PREFER case study acronym: Pfizer-Lily

Clinical objectives: Quantify patient preferences for pharmaceutical treatments for chronic moderate-to-severe musculoskeletal pain associated with osteoarthritis (OA) and chronic low back pain (CLBP). Understand patients’ preferences for, and potential trade-offs among, treatment attributes that are most relevant to them and that correspond to existing and potential alternative treatment options

Patients from: Patients recruited from US and UK online panels maintained by a company called Dynata. Panel members are recruited via partnerships with trusted loyalty programs, as well as through banner ads, pop-ups and messages on websites, television

Methods in Qualitative study: Focus groups

Methods in Quantitative study:Discrete Choice Experiment (DCE), Best-worst Scaling Case 1

End-date qualitative data collection: US data collection: March 2019, UK data collection: March 2019

End-date quantitative data collection : US data collection: 20 March 2019, UK data collection: TBC

PUBLICATIONS

D. Turk, M. Boeri, L. Abraham, J. Atkinson, A.G. Bushmakin, J.C. Cappelleri, B. Hauber, K. Klein, L. Russo, L. Viktrup, D. Walsh, Patient preferences for osteoarthritis pain and chronic low back pain treatments in the United States: a discrete-choice experiment, Osteoarthritis and Cartilage, Volume 28, Issue 9, 2020, Pages 1202-1213.

D.C. Turk, A plain-language summary to complement a publication reporting patient preferences for analgesic therapy characteristics by Turk et al., Osteoarthritis and Cartilage, Volume 29, Issue 8, 2021, Pages 1237-1238,

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PREFER

The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).