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 (Bindawas et al., 2015; Farr et al., 2013; Gore et al., 2012; Gore et al., 2011; Ma et al., 2014). Pharmacologic therapy for OA and CLBP often includes non-steroidal anti-inflammatory drugs (NSAIDs) and opioids, typically in a step-up approach (McAlindon et al., 2014; Qaseem et al., 2017).

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 (Kissin, 2010). 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 (Aronson, 2009).

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 the long-acting injectable treatments currently being investigated.

Pfizer and Lilly are collaborating on the development of tanezumab, a novel treatment for chronic pain. Tanezumab, a nonopioid analgesic administered subcutaneously every 8 weeks, is being investigated in 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. This report contains only the US results because of the limited generalizability of preference data and different data-collection periods across the regions (i.e., UK study was fielded later).

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 acromym 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 future 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: 7 December 2017

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

UK data collection: TBC

References

Bindawas SM, Vennu V, Auais M. Health-related quality of life in older adults with bilateral knee pain and back pain: data from the Osteoarthritis Initiative. Rheumatol Int. 2015 Dec;35(12):2095-101.

Farr II J, Miller LE, Block JE. Quality of life in patients with knee osteoarthritis: a commentary on nonsurgical and surgical treatments. Open Orthop J. 2013 Nov 13;7:619 23.

Gore M, Tai KS, Sadosky A, Leslie D, Stacey BR. Clinical comorbidities, treatment patterns, and direct medical costs of patients with osteoarthritis in usual care: a retrospective claims database analysis. J Med Econ. 2011;14(4):497-507.

Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D. The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings. Spine (Phila Pa 1976). 2012 May 15;37(11):E668-77.

Kissin I. The development of new analgesics over the past 50 years: a lack of real breakthrough drugs. Anesth Analg. 2010 Mar 1;110(3):780-9. doi: 10.1213/ANE.0b013e3181cde882.

Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1.

McAlindon TE, Bannuru RR, Sullivan MC, Arden NK, Berenbaum F, Bierma-Zeinstra SM, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014 Mar;22(3):363-88.

Qaseem A, Wilt TJ, McLean RM, Forciea MA; Clinical Guidelines Committee of the American College of Physicians. Noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. [Epub ahead of print; 2017 Feb 14]