Subcutaneous tanezumab for osteoarthritis: Is the early improvement in pain and function meaningful and sustained?

Bérenbaum, Francis; Langford, R. M.; Perrot, Serge; Miki, Kenji; Blanco, Francisco J.; Yamabe, Takaharu; Isogawa, Naoki; Junor, Rod; Carey, William; Viktrup, Lars; West, Christine R.; Brown, Mark T.; Verburg, Kenneth M.

doi:10.1002/ejp.1764

Cited by 8 publications

(12 citation statements)

References 19 publications

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“…Early clinical trials of tanezumab were aimed at studying the clinical efficacy of intravenous administration [ 68 , 69 , 76 , 77 , 79 , 80 , 81 ]; in contrast, more recent and ongoing trials study the efficacy of subcutaneous administration, and results seem to indicate that 5 mg is the minimum dose for achieve a valuable clinical reduction in pain and an improvement in quality of life [ 49 , 70 , 78 , 82 , 83 ].…”

Section: Mabs In Osteoarthritis Painmentioning

confidence: 99%

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Monoclonal Antibodies for Chronic Pain Treatment: Present and Future

Sánchez¹,

Girón²,

Paniagua³

et al. 2021

IJMS

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Chronic pain remains a major problem worldwide, despite the availability of various non-pharmacological and pharmacological treatment options. Therefore, new analgesics with novel mechanisms of action are needed. Monoclonal antibodies (mAbs) are directed against specific, targeted molecules involved in pain signaling and processing pathways that look to be very effective and promising as a novel therapy in pain management. Thus, there are mAbs against tumor necrosis factor (TNF), nerve growth factor (NGF), calcitonin gene-related peptide (CGRP), or interleukin-6 (IL-6), among others, which are already recommended in the treatment of chronic pain conditions such as osteoarthritis, chronic lower back pain, migraine, or rheumatoid arthritis that are under preclinical research. This narrative review summarizes the preclinical and clinical evidence supporting the use of these agents in the treatment of chronic pain.

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Section: Mabs In Osteoarthritis Painmentioning

confidence: 99%

“…Risk of RPOA at high doses. [ 49 , 68 , 69 , 70 , 71 , 72 , 76 , 77 , 78 , 79 , 80 , 81 , 82 , 83 , 157 ] Fulranumab Greater pain relief relative to oxycodone. Arthralgias and risk of RPOA associated to treatment.…”

Section: Future Applications Of Mabs In Preclinical Development: Cancer Pain and Pain In Bone Fracturementioning

confidence: 99%

Monoclonal Antibodies for Chronic Pain Treatment: Present and Future

Sánchez¹,

Girón²,

Paniagua³

et al. 2021

IJMS

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“…Of the overall population, 696 were enrolled in North America [ 14 ], 743 were enrolled in Europe [ 24 ], and 106 were enrolled in Japan [ 24 ]. Across the three treatment groups (placebo, tanezumab 2.5 mg, tanezumab 5 mg) in the overall population, the index joint was a knee for 83.9–84.4% of patients, KL grade 3 for 43.0–45.1%, and KL grade 4 for 32.9–33.5% of patients, and WOMAC Pain score (mean) was 6.9 (Table 1 ).…”

Section: Resultsmentioning

confidence: 99%

Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis

Conaghan

Abraham

Viktrup

et al. 2022

BMC Musculoskelet Disord

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Background To evaluate the impact of tanezumab on health status, non-work activities, and work productivity in a pooled analysis of two large phase 3 osteoarthritis (OA) studies. Methods Subcutaneous tanezumab (2.5 mg and 5 mg) was tested in double-blind, placebo-controlled, 16-week (NCT02697773) and 24-week (NCT02709486) clinical trials in patients with moderate-to-severe OA of the hip or knee. At baseline and week 16, all patients completed EQ-5D-5L and the Work Productivity and Activity Impairment-OA (WPAI-OA) activity impairment item. Those currently employed also completed WPAI-OA work time missed, impairment while working, and overall work impairment items. Between-group differences in least squares (LS) mean changes from baseline at week 16 were tested using analysis of covariance. Results Of 1545 pooled patients, 576 were employed at baseline. Improvements in EQ-5D-5L index value at week 16 were significantly greater for the tanezumab 2.5-mg group (difference in LS means [95% confidence interval (CI), 0.03 [0.01, 0.05]; p = 0.0083) versus placebo. Percent improvements (95% CI) in activity impairment (− 5.92 [− 8.87, − 2.98]; p < 0.0001), impairment while working (− 7.34 [− 13.01, − 1.68]; p = 0.0112), and overall work impairment (− 7.44 [− 13.22, − 1.67]; p = 0.0116) at week 16 were significantly greater for the tanezumab 2.5-mg group versus placebo. Results for the tanezumab 5-mg group were generally comparable to the tanezumab 2.5-mg group, although, compared with placebo, percent improvement (95% CI) in work time missed was significantly greater for the tanezumab 5-mg group (− 3.40 [− 6.47, − 0.34]; p = 0.0294), but not the tanezumab 2.5-mg group (− 0.66 [− 3.63, 2.32]; p = 0.6637). Conclusions These pooled analyses showed that health status, non-work activities, and work productivity were significantly improved following tanezumab administration, compared with placebo. Trial registration ClinicalTrials.gov: NCT02697773, NCT02709486.

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“…The efficacy and general safety results of a subgroup analysis of the Japanese patients from Study 2 have been published [ 23 ]. In the current analysis, we included efficacy and overall safety findings of the Japanese patients from Study 1; Japanese patients from Study 2 were only included in the integrated safety analysis.…”

Section: Methodsmentioning

confidence: 99%

Efficacy, General Safety, and Joint Safety of Tanezumab in Japanese Patients with Osteoarthritis: Subgroup Analyses from Two Randomized, Phase 3 Studies

Miki¹,

Ohta

Abe

et al. 2022

Pain Ther

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Introduction Tanezumab is a monoclonal antibody against nerve growth factor that is under investigation for the treatment of osteoarthritis (OA) pain. We conducted subgroup analyses of two randomized phase 3 studies to summarize efficacy, general safety, and adjudicated joint safety of tanezumab in Japanese patients with moderate-to-severe OA. Methods In Study 1 (NCT02528188), patients received subcutaneous tanezumab 2.5 mg or 5 mg every 8 weeks or daily oral nonsteroidal anti-inflammatory drugs (NSAID) for 56 weeks. The co-primary efficacy endpoints were change from baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale score and WOMAC Physical Function subscale score at Week 16 (overall study and Japan-specific endpoints) as well as Patient Global Assessment (PGA)-OA score at Week 16 (overall study endpoint only). In Study 2 (NCT02709486), patients received subcutaneous tanezumab 2.5 mg, 5 mg, or placebo every 8 weeks for 24 weeks. Safety monitoring included adjudicated composite joint safety endpoint (CJSE) including rapidly progressive osteoarthritis type 1 (RPOA1), RPOA2, primary osteonecrosis, pathological fracture, or subchondral insufficiency fracture. Results For Study 1, Japanese patients ( n = 200) treated with tanezumab 2.5 mg and 5 mg showed numerically greater improvements in WOMAC Pain, WOMAC Physical Function, and PGA-OA scores versus NSAID at Week 16. Incidences of treatment-emergent adverse events were generally similar between tanezumab 2.5 mg, 5 mg, and NSAID groups. In the integrated safety analysis (Studies 1 + 2; n = 306), ten patients were adjudicated to have a component of CJSE: RPOA1 [tanezumab 2.5 mg ( n = 2), tanezumab 5 mg ( n = 5)], RPOA2 [tanezumab 2.5 mg ( n = 1), tanezumab 5 mg ( n = 1)], or primary osteonecrosis [tanezumab 2.5 mg ( n = 1)]. Time-adjusted adjudicated rates of RPOA1 and RPOA2 were higher with tanezumab than NSAID or placebo and increased with dose of tanezumab. Conclusion Observations from the Japanese subgroup were generally consistent with the overall study populations. Supplementary Information The online version contains supplementary material available at 10.1007/s40122-022-00384-y.

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Subcutaneous tanezumab for osteoarthritis: Is the early improvement in pain and function meaningful and sustained?

Cited by 8 publications

References 19 publications

Monoclonal Antibodies for Chronic Pain Treatment: Present and Future

Monoclonal Antibodies for Chronic Pain Treatment: Present and Future

Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis

Efficacy, General Safety, and Joint Safety of Tanezumab in Japanese Patients with Osteoarthritis: Subgroup Analyses from Two Randomized, Phase 3 Studies

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