Background Intra-articular (IA) glucocorticoid injections are often employed in the management of osteoarthritis (OA) patients, but in whom to best target treatment is unclear. OA clinical guidelines have advocated for the identification of predictors of response to different treatments, but no reliable subgroups with treatment effect have been found.

Objectives This study aims to conduct an individual patient data (IPD) meta-analysis to evaluate the efficacy of IA glucocorticoid for knee or hip OA in specific subgroups of patients according to the baseline pain severity and inflammatory signs. This is an update on an IPD meta-analysis on IA glucocorticoid by the OA Trial Bank ^[1].

Methods Randomised trials evaluating one or more IA glucocorticoid preparations in hip and knee OA, published from 2012 to May 2018, were selected from the literature. IPD of participant and disease characteristics and outcome measures were acquired. The primary outcome was pain severity at short-term follow-up (around 4 weeks). A two-stage IPD analysis was performed. Potential interaction effect of baseline severe pain (≥70 points, 0-100 scale) and signs of inflammation were studied using linear mixed-effects models. Analysis of trend was conducted, assessing if a baseline pain cut-off was associated with the threshold for clinically important treatment effect of IA glucocorticoid compared to placebo.

Results Four out of 16 eligible randomised clinical trials (n=641) were combined with the existing OA Trial Bank studies (n=620), yielding n=1261 from eleven studies. Participants with severe baseline pain compared to those with less severe pain had greater pain reduction at mid-term (around 12 weeks) (mean reduction: -6.90 (95%CI -10.91; -2.90)), but not at short- or long-term follow-up. No interaction effects were found between inflammatory signs and IA glucocorticoid injections compared to placebo at all follow-up time-points (Table 1). Analysis of trend showed treatment response to IA glucocorticoid injections from baseline pain levels >50 (0-100 scale) and above (Figure 1).

Conclusion This IPD meta-analysis demonstrated that in participants with severe baseline pain, clinically relevant response is seen at mid-term follow-up, suggesting that sustained response to IA glucocorticoid injection may be seen in a subgroup of OA participants. As baseline pain score increases, treatment response is seen in participants from moderate pain levels onwards. No concrete conclusions can be made on baseline inflammatory signs. Ongoing IPD studies with an increased number of studies are required.

Reference [1]van Middelkoop M, Arden NK, Atchia I, U, et al. The OA Trial Bank: meta-analysis of individual patient data from knee and hip osteoarthritis trials show that patients with severe pain exhibit greater benefit from intra-articular glucocorticoids. Osteoarthritis Cartilage 2016; 24: 1143-1152.

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Acknowledgements All data contributors (researchers and institutions) are to be acknowledged for the provision of their data to the OA Trial Bank. This publication includes research using data from data contributors Sanofi that has been made available through Vivli, Inc. Vivli has not contributed to or approved, and is not in any way responsible for, the contents of this publication.

Disclosure of Interests Shirley Yu: None declared, Marienke Van Middelkoop: None declared, Manuela Ferreira: None declared, Leticia Deveza: None declared, S.M.A. Bierma-Zeinstra: None declared, Venkatesha Venkatesha: None declared, David Hunter Consultant of: Provides consulting advice to Merck Serono, Pfizer, Lilly, TLCBio, Novartis.