TY - JOUR
T1 - A Two-Step, Trajectory-Focused, Analytics Approach to Attempt Prediction of Analgesic Response in Patients with Moderate-to-Severe Osteoarthritis
AU - Atkinson, Joanna
AU - Edwards, Roger A.
AU - Bonfanti, Gianluca
AU - Barroso, Joana
AU - Schnitzer, Thomas J.
N1 - Funding Information:
This study was funded by Pfizer and Eli Lilly and Company. The journal’s Rapid Service fee was funded by Pfizer and Eli Lilly and Company.
Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer Healthcare Ltd., part of Springer Nature.
PY - 2022
Y1 - 2022
N2 - Introduction: We sought to predict analgesic response to daily oral nonsteroidal anti-inflammatory drugs (NSAIDs) or subcutaneous tanezumab 2.5 mg (every 8 weeks) at week 16 in patients with moderate-to-severe osteoarthritis, based on initial treatment response over 8 weeks. Methods: Data were derived from three randomized controlled trials of osteoarthritis. A two-step, trajectory-focused, analytics approach was used to predict patients as responders or non-responders at week 16. Step 1 identified patients using a data-element combination method (based on pain score at baseline, pain score at week 8, pain score monotonicity at week 8, pain score path length at week 8, and body site [knee or hip]). Patients who could not be identified in step 1 were predicted in step 2 using a k-nearest neighbor method based on pain score and pain response level at week 8. Results: Our approach predicted response with high accuracy in NSAID-treated (83.2–90.2%, n = 931) and tanezumab-treated (84.6–91.0%, n = 1430) patients regardless of the efficacy measure used to assess pain, or the threshold used to define response (20%, 30%, or 50% improvement from baseline). Accuracy remained high using 50% or 20% response thresholds, with 50% and 20% yielding generally slightly better negative and positive predictive value, respectively, relative to 30%. Accuracy was slightly better in patients aged ≥ 65 years relative to younger patients across most efficacy measure/response threshold combinations. Conclusions: Analyzing initial 8-week analgesic responses using a two-step, trajectory-based approach can predict future response in patients with moderate-to-severe osteoarthritis treated with NSAIDs or 2.5 mg tanezumab. These findings demonstrate that prediction of treatment response based on a single dose of a novel therapeutic is possible and that predicting future outcomes based on initial response offers a way to potentially advance the approach to clinical management of patients with osteoarthritis. ClinicalTrials.gov Identifiers: NCT02528188, NCT02709486, NCT02697773.
AB - Introduction: We sought to predict analgesic response to daily oral nonsteroidal anti-inflammatory drugs (NSAIDs) or subcutaneous tanezumab 2.5 mg (every 8 weeks) at week 16 in patients with moderate-to-severe osteoarthritis, based on initial treatment response over 8 weeks. Methods: Data were derived from three randomized controlled trials of osteoarthritis. A two-step, trajectory-focused, analytics approach was used to predict patients as responders or non-responders at week 16. Step 1 identified patients using a data-element combination method (based on pain score at baseline, pain score at week 8, pain score monotonicity at week 8, pain score path length at week 8, and body site [knee or hip]). Patients who could not be identified in step 1 were predicted in step 2 using a k-nearest neighbor method based on pain score and pain response level at week 8. Results: Our approach predicted response with high accuracy in NSAID-treated (83.2–90.2%, n = 931) and tanezumab-treated (84.6–91.0%, n = 1430) patients regardless of the efficacy measure used to assess pain, or the threshold used to define response (20%, 30%, or 50% improvement from baseline). Accuracy remained high using 50% or 20% response thresholds, with 50% and 20% yielding generally slightly better negative and positive predictive value, respectively, relative to 30%. Accuracy was slightly better in patients aged ≥ 65 years relative to younger patients across most efficacy measure/response threshold combinations. Conclusions: Analyzing initial 8-week analgesic responses using a two-step, trajectory-based approach can predict future response in patients with moderate-to-severe osteoarthritis treated with NSAIDs or 2.5 mg tanezumab. These findings demonstrate that prediction of treatment response based on a single dose of a novel therapeutic is possible and that predicting future outcomes based on initial response offers a way to potentially advance the approach to clinical management of patients with osteoarthritis. ClinicalTrials.gov Identifiers: NCT02528188, NCT02709486, NCT02697773.
KW - k-Nearest neighbors
KW - Nonsteroidal ant-inflammatory drugs
KW - Osteoarthritis
KW - Pain
KW - Prediction
KW - Tanezumab
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U2 - 10.1007/s12325-022-02336-6
DO - 10.1007/s12325-022-02336-6
M3 - Article
C2 - 36301512
AN - SCOPUS:85140839762
JO - Advances in Therapy
JF - Advances in Therapy
SN - 0741-238X
ER -