POS0230 DISAGREEMENT BETWEEN PATIENT AND PHYSICIAN GLOBAL ASSESSMENT OVER TIME IN PSORIATIC ARTHRITIS: INSIGHT INTO TREATMENT PRIORITIES

Background

The PsA core domain set developed by the Outcome Measures in Rheumatology working group includes musculoskeletal disease, fatigue, physical function, and structural damage, of which arthritis activity, pain, and fatigue were identified as essential by both patients (Pts) and physicians (Phs).^[1-2] Assessing agreement between Pt and Ph global assessments (GA) may provide valuable insight into differential importance of specific PsA manifestations to Pts vs Phs. Although previous studies have assessed Pt/Ph disagreement, they have not evaluated potential variation over time.^[3]

Objectives

To assess agreement of PtGA and PhGA through week (W) 24 and identify factors driving disagreement between PtGA and PhGA using pooled data (N=1120) from the phase 3 DISCOVER (D)-1 & -2 studies of the fully human IL-23p19 subunit inhibitor (i), guselkumab (GUS).

Methods

Pts with active PsA despite standard therapies (D1: ≥3 swollen/tender joint counts [SJC/TJC], CRP ≥0.3 mg/dL, ~30% with prior TNFi; D2: ≥5 SJC/TJC, CRP ≥0.6 mg/dL, biologic-naïve) were randomized 1:1:1 to GUS 100 mg every 4 weeks (Q4W); GUS 100 mg at W0, W4, Q8W; or placebo. Pt/Ph agreement was defined as a difference of -15<PhGA-PtGA<15. Determinants of PhGA exceeding PtGA by ≥15 (PhGA>PtGA) and PtGA exceeding PhGA by ≥15 (PtGA>PhGA) among pts with PtGA/PhGA disagreement were assessed with the same logistic regression model considering pt demographics, disease characteristics, and pt-reported outcomes (PROs). The effect of GUS on disease parameters identified as determinants of PtGA vs. PhGA disagreement was assessed with repeated measures mixed models adjusting for treatment group, baseline (BL) levels, prior TNFi use, and BL DMARD use.

Results

At BL, mean (SD) SJC=11.5 (7.4), TJC=20.6 (13.3), FACIT-Fatigue score=29.9 (10.0), PtGA=66.9 (19.9), and PhGA=64.8 (15.9) were consistent with moderate to high disease activity. Agreement between PtGA and PhGA was seen in most instances (61.2%); 23.2% of cases were characterized by PtGA>PhGA and 15.7% by PhGA>PtGA. The proportion of pts with PtGA>PhGA increased to 39.1% at W24, while that with PhGA>PtGA decreased to 11.2%. The main determinant of PtGA>PhGA was higher Pt Pain (all time points); additional factors included worse physical health-related quality of life at BL and worse fatigue at W24 (Table 1). Conversely, Phs emphasized objective disease measures, namely higher SJC (all time points) and TJC (W8 to W24), and elevated CRP (BL to W16). GUS treatment was associated with prompt and sustained significant improvements in all identified determinants, including those driving PtGA>PhGA (Figure 1).

Conclusion

PtGA and PhGA were aligned in most encounters. PtGA>PhGA disagreement was driven by pain, fatigue, and physical health being weighed more by Pts than Phs. These findings have important implications in shared decision making and highlight the need to prioritize treatments addressing the full spectrum of PsA symptoms, including PROs.

References

[1]Leung YY, et al. J Rheum. 2020 (Suppl);96:46 [2]Mease PJ, et al. Ann Rheum Dis. 2022;81:879 [3]Desthieux C, et al. Arthritis Care Res. 2017;69:1606

Acknowledgements:

NIL.

Disclosure of Interests

Proton Rahman Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Grant/research support from: Janssen and Novartis, Laura Coates Speakers bureau: AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Medac, Novartis, Pfizer and UCB, Consultant of: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Celgene, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Peter Nash Grant/research support from: AbbVie, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Janssen, Pfizer, Novartis, Roche, Sandoz, and Sun Pharmaceutical Industries, Atul Deodhar Speakers bureau: AbbVie, Eli Lilly, Janssen, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Aurinia, Bristol Myers Squibb, Celgene, Eli Lilly, GlaxoSmithKline, Janssen, MoonLake, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer, and UCB, Francois Nantel Shareholder of: Johnson & Johnson, Consultant of: Janssen, Emmanouil Rampakakis Consultant of: Janssen, Employee of: JSS Medical Research, Louis Bessette Speakers bureau: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Fresenius Kabi, Janssen, MSD, Novartis, Pfizer, Sandoz, Sanofi, Teva, and UCB, Consultant of: AbbVie, Amgen, Bristol Myers Squibb, Eli Lilly, Fresenius Kabi, Gilead, Janssen, MSD, Novartis, Pfizer, Sandoz, Sanofi, Teva, and UCB, Grant/research support from: AbbVie, Amgen, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, MSD, Novartis, Pfizer, Sanofi, and UCBA, Marilise Marrache Shareholder of: Johnson & Johnson, Employee of: Janssen Inc., Toronto, Canada, Frederic Lavie Shareholder of: Johnson & Johnson, Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, May Shawi Shareholder of: Johnson & Johnson, Employee of: Immunology Global Medical Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson, William Tillett Speakers bureau: AbbVie, Amgen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Consultant of: AbbVie, Amgen, Eli Lilly, Janssen, MSD, Novartis, Pfizer, and UCB, Grant/research support from: AbbVie, Amgen, Eli Lilly, Janssen, and UCB.