Session Type: ACR Poster Session A
Session Time: 9:00AM-11:00AM
Background/Purpose: Osteoarthritis (OA) is an important cause of chronic pain in older adults. Fasinumab is a fully-human, high-affinity monoclonal antibody directed against the nerve growth factor (NGF). By selectively blocking NGF, fasinumab has the potential to effectively modulate NGF‑associated pain without causing some of the well-known adverse side effects of commonly used analgesic medications such as opioids and NSAIDS. We assessed the efficacy and safety of fasinumab on pain due to OA in patients with intolerance or inadequate pain relief from analgesics.
Methods: Adult patients were required to have a diagnosis of OA of the knee or hip based on American College of Rheumatology classification criteria. Eligible patients had an inadequate response or were intolerant to standard-of-care pain medications. Patients were required to have a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score of ≥4 and a Kellgren-Lawrence X-ray grading of ≥2 in at least one hip or knee joint. Patients were excluded if they had evidence of joint instability on screening imaging or if they had significant concomitant medical conditions that could interfere with the efficacy or safety assessments. Eligible patients were randomized to receive placebo or 1 mg, 3 mg, 6 mg, or 9 mg of fasinumab subcutaneously every 4 weeks through Week 12. Primary efficacy was measured as a change from baseline to week 16 for the WOMAC pain subscale. WOMAC physical function and Patient Global Assessment (PGA) were measured as secondary endpoints. The primary efficacy variables were analyzed using a mixed-effect model repeated measure approach.
Results: Four hundred and nineteen subjects received at least one dose of study medication. At week 16, LS mean changes from baseline in the WOMAC pain subscale in patients were -2.25 for placebo, -3.35 (1 mg), -3.33 (3 mg), -3.03 (6 mg), and -3.65 (9 mg) for the fasinumab groups; all fasinumab groups showed significant improvement vs placebo (p≤0.05). Improvements were also observed for WOMAC physical function and PGA. Fasinumab was generally well tolerated. As expected for the class of NGF antibodies, certain neuromuscular events, including arthralgia, paraesthesia, hypoaesthesia, and peripheral edema, occurred more commonly in fasinumab treated patients. During the study period, there were the following number of subchondral insufficiency fracture cases: 1, 0, 2, 0, and 4 in the placebo, 1 mg, 3 mg, 6 mg and 9 mg groups, respectively. There was 1 case of rapidly progressive osteoarthritis in each of the 3 mg, 6 mg, and 9 mg fasinumab groups.
Conclusion: <span”,’serif’; mso-fareast-language:=”mso-fareast-language:” mso-ansi-language:=”mso-ansi-language:” mso-fareast-theme-font:=”mso-fareast-theme-font:” font-size:=”font-size:” ar-sa;”=”AR-SA;”” mincho’;=”Mincho’;” mso-fareast-‘ms=”mso-fareast-‘MS” 12pt;=”12pt;” minor-fareast;=”minor-fareast;” en-us;=”EN-US;” mso-bidi-language:=”mso-bidi-language:”>These 16-week results suggest that fasinumab provided significant clinical benefit in relieving osteoarthritic pain compared with placebo in patients with moderate to severe OA who have inadequate pain relief or are intolerant to other analgesics. Fasinumab was generally well tolerated in the majority of patients in this study. Clinicaltrials.gov NCT02447276
To cite this abstract in AMA style:Maloney J, Kivitz A, Schnitzer TJ, Dakin P, Stehman-Breen C, Geba G. Efficacy and Safety of Fasinumab for Osteoarthritic Pain in Patients with Moderate to Severe Osteoarthritis of the Knees or Hips [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/efficacy-and-safety-of-fasinumab-for-osteoarthritic-pain-in-patients-with-moderate-to-severe-osteoarthritis-of-the-knees-or-hips/. Accessed December 2, 2020.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/efficacy-and-safety-of-fasinumab-for-osteoarthritic-pain-in-patients-with-moderate-to-severe-osteoarthritis-of-the-knees-or-hips/