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Objectives This analysis evaluated associations between clinically important improvements in PROs and reduced disease activity from the phase 2 SLEek study evaluating upadacitinib (UPA) vs placebo (PBO) in patients with SLE.Methods Data are reported for patients who received UPA 30mg monotherapy or PBO for 48 weeks. Assessments included BICLA, SRI-4, and LLDAS responses among patients who reported or did not report MCID in PROs at weeks 24 and 48 ( table 1). Between-group differences and P-values were estimated using Cochran-Mantel-Haenszel test, adjusted for baseline corticosteroid dose, SLEDAI-2K score at screening, baseline interferon score, and baseline immunosuppressant use.Results 137 patients were included in the analysis (UPA, n=62; PBO, n=75); 90% were female, most were White. Mean baseline FACIT-Fatigue, SF-36 PCS, SF-36 MCS, Pain NRS scores were 29.3, 40.3, 42.4, 5.3 (PBO); and 27.1, 38.2, 43.7, 7.1 (UPA). Among patients who reported PRO changes>=MCID at week 48, a higher proportion achieved SRI-4, BICLA, and LLDAS responses with UPA vs PBO (P <.05 for most; figure 1). Similar trends were observed at week 24 (figure 1). SRI-4, BICLA, and LLDAS responses at weeks 24 and 48 were lower among patients who did not report PRO change >/=MCID ; however, a higher proportion of these patients achieved SRI-4, BICLA, and LLDAS responses with UPA vs PBO. Of patients who received UPA and reported changes >/=MCID for FACIT-Fatigue at week 48, over 80% achieved SRI-4 and BICLA responses, and approximately three-quarters achieved LLDAS (figure 1A). In patients who received UPA and reported changes >/=MCID in SF-36 PCS or MCS scores or Pain NRS at week 48, over 80% achieved BICLA, and SRI-4 and LLDAS were achieved by approximately three-quarters of patients who reported changes >/=MCID for SF-36 PCS scores (figure 1B) and approximately two-thirds of patients who reported changes >/=MCID for SF-36 MCS scores (figure 1C) and Pain NRS (figure 1D).Abstract PT4:08 Table 1MCID thresholdsAbstract PT4:08 Figure 1Proportion of patients achieving SRI-4, BICLA, or LLDAS responses with upadacitinib vs placebo based on changes in MCID for (A) FACIT-fatigue, (B) SF-36 PCS scores, (C) SF-36 MCS scores, or (D) pain NRS at weeks 24 and 48 (NRI)Conclusions Patients who reported changes >/=MCID in PROs generally demonstrated higher SRI-4, BICLA, and LLDAS responses than those who did not. These findings demonstrate the strong association of PRO improvements with disease activity improvements in SLE and highlight the potential multifaceted benefits of UPA for patients with SLE.