Objective We aimed to evaluate whether subgroups with more severe inflammatory symptoms during a knee pain flare benefited more from a high dose ibuprofen treatment than subgroups with less severe inflammatory symptoms. Methods This secondary analysis included adults with ≥ 1 flares of knee pain in the last year, who experienced a new episode within 24 h and randomized into two treatment groups of daily ibuprofen 1200 mg or 2400 mg for 5 days. A multilevel regression analysis was used to assess interaction effects between intervention groups and pre-defined subgroups, based on osteoarthritis related symptoms (severity of morning stiffness, swelling, and pain). The primary outcome was the difference in treatment effect between subgroups on pain severity (0–10 on the numeric rating scale (NRS)) after 5 days. Differences in treatment effect between subgroups after 3 days (NRS) and 5 days (Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale) were secondary outcomes. Results Participants (N = 308) had a mean age of 52.4 ± 12.9 (SD) years with 41% female subjects. No significant interaction was found between the pre-defined subgroups and intervention groups on pain severity after day 5 (all p-values ≥ 0.28) or on the secondary outcomes (all p-values ≥ 0.38). Given the potential lack of power, the absolute and adjusted mean differences between treatment arms were compared for each subgroup; none of the differences reached clinical significance. Conclusion Between subgroups with more and less severe inflammatory symptoms during knee pain flares, no significant nor clinical benefit was found from a higher dose of ibuprofen compared to a lower dose.<Table Float="No" ID="Taba"> <tgroup cols="2"> <colspec align="left" colname="c1" colnum="1" /> <colspec align="left" colname="c2" colnum="2" /> <tbody> <row> <entry align="left" nameend="c2" namest="c1"> Keypoints • Despite the overall superiority of the higher dose, patients with severe inflammatory knee symptoms do not benefit more from an anti-inflammatory dose of ibuprofen than patients with less severe symptoms. • A higher dose of ibuprofen is not indicated for patients with severe inflammatory knee symptoms. • Given the heterogeneity among patients with knee osteoarthritis, potential subgroups should be explored in future research. </entry> </row> </tbody> </tgroup> </Table>

Identifying clinically relevant subgroups of patients with knee pain flares for ibuprofen treatment: a secondary analysis

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2025年6月25日

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R. U. Sharma,
J. Runhaar,
P. K. Bos,
D. M. J. Dorleijn,
P. J. E. Bindels,
S. M. A. Bierma-Zeinstra

摘要

Objective

We aimed to evaluate whether subgroups with more severe inflammatory symptoms during a knee pain flare benefited more from a high dose ibuprofen treatment than subgroups with less severe inflammatory symptoms.

Methods

This secondary analysis included adults with ≥ 1 flares of knee pain in the last year, who experienced a new episode within 24 h and randomized into two treatment groups of daily ibuprofen 1200 mg or 2400 mg for 5 days. A multilevel regression analysis was used to assess interaction effects between intervention groups and pre-defined subgroups, based on osteoarthritis related symptoms (severity of morning stiffness, swelling, and pain). The primary outcome was the difference in treatment effect between subgroups on pain severity (0–10 on the numeric rating scale (NRS)) after 5 days. Differences in treatment effect between subgroups after 3 days (NRS) and 5 days (Western Ontario and McMaster Universities Osteoarthritis (WOMAC) scale) were secondary outcomes.

Results

Participants (N = 308) had a mean age of 52.4 ± 12.9 (SD) years with 41% female subjects. No significant interaction was found between the pre-defined subgroups and intervention groups on pain severity after day 5 (all p-values ≥ 0.28) or on the secondary outcomes (all p-values ≥ 0.38). Given the potential lack of power, the absolute and adjusted mean differences between treatment arms were compared for each subgroup; none of the differences reached clinical significance.

Conclusion

Between subgroups with more and less severe inflammatory symptoms during knee pain flares, no significant nor clinical benefit was found from a higher dose of ibuprofen compared to a lower dose.

Keypoints

• Despite the overall superiority of the higher dose, patients with severe inflammatory knee symptoms do not benefit more from an anti-inflammatory dose of ibuprofen than patients with less severe symptoms.

• A higher dose of ibuprofen is not indicated for patients with severe inflammatory knee symptoms.

• Given the heterogeneity among patients with knee osteoarthritis, potential subgroups should be explored in future research.