Background/Purpose: Subcutaneous (SC) tanezumab, a monoclonal antibody that inhibits nerve growth factor, was investigated for the relief of signs and symptoms of moderate-severe OA in patients (pts) for whom use of other analgesics was ineffective or not appropriate in a randomized NSAID-controlled long-term global safety study (NCT02528188). The primary safety (joint safety over 80 weeks [Wk]) and coprimary efficacy endpoints (pain, function, and Pt Global Assessment of OA [PGA-OA] at Wk 16) were recently disclosed.^1,2 The current analysis examines the time-course and longer term maintenance of treatment effect of tanezumab versus NSAID on pain and physical function through Wk 56.

Methods: Eligible pts had hip or knee OA based on ACR criteria with x-ray confirmation; baseline (BL) WOMAC Pain and Physical Function subscale scores of ≥5; BL PGA-OA of “fair”, “poor”, or “very poor”; history of inadequate pain relief with acetaminophen; inadequate pain relief with/intolerance tramadol or opioids, or unwilling to take opioids. Pts were on a qualifying, stable dose of NSAID before study entry. Pts received SC tanezumab (2.5 mg or 5 mg every 8 Wks) or oral NSAID (BID) over the 56-Wk treatment period. At Wk 16, pts who did not have the required efficacy response (≥15% reduction from BL at Wk 2, 4, or 8, and ≥30% reduction from BL in WOMAC Pain at Wk 16) were discontinued from study treatment and entered the safety follow-up period. Pts were permitted to use rescue medication (≤3000 mg/day acetaminophen) up to 3 days/Wk up to Wk 16 and daily thereafter. Treatment effect through Wk 56 versus NSAID was evaluated by measuring change from BL in average index joint pain (electronic pain diary: daily from Day 1 to Wk 16, then weekly to end of study) and WOMAC Pain and Physical Function, and PGA-OA scores (Wk 2 through Wk 56 at clinic visits). Unadjusted p-values are presented.

Results: In total, 3,021 pts were randomized and 2,996 included in the efficacy analyses. A total of 1,312 pts completed the treatment period (42–45% across treatment groups). BL pt characteristics were similar across treatment groups: mean age 60.3–61.2 years; duration of index joint OA 7.9–8.1 years; index joint was the knee 84.9–85.5%; female 63.6–66.5%. Reductions from BL in average index joint pain scores were largely similar across treatment groups from BL to Wk 4 (Figure 1). From Wk 4 to Wk 20 reductions were significantly greater (P≤0.05) in both tanezumab groups versus NSAID. Changes from BL in WOMAC Pain, Physical Function and PGA-OA scores were largely similar across treatment groups but there were scattered significant improvements for pts receiving tanezumab versus NSAID at Wks 4, 8 and 16 (Figure 2). Changes in WOMAC Pain, Physical Function and PGA-OA scores across treatment groups were generally maintained up to Wk 56.

Conclusion: Pts with moderate-severe hip or knee OA treated with tanezumab or NSAID experienced an early improvement in pain and function that was maintained long-term.

Disclosures: Sponsored by Pfizer and Eli Lilly & Company.

References:

1. Hochberg M, et al. ACR/ARHP 2019 Annual Scientific Meeting. 2019;71(S10):4888.
2. Hochberg M, et al. ACR/ARHP 2019 Annual Scientific Meeting. 2019;71(S10):2243.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/observed-efficacy-with-subcutaneous-tanezumab-is-early-and-maintained-in-patients-with-osteoarthritis-results-from-a-56-week-randomized-nsaid-controlled-study/