Persistence and effectiveness of the IL-12/23 pathway inhibitor ustekinumab or tumour necrosis factor inhibitor treatment in patients with psoriatic arthritis: 1-year results from the real-world PsABio Study

Abstract

Objective: We evaluated real-world treatment persistence and effectiveness at 1 year following initiation of IL-12/23 inhibitor ustekinumab or a tumour necrosis factor inhibitor (TNFi) for psoriatic arthritis (PsA).

Methods: PsABio (NCT02627768), a prospective, observational study, followed patients with PsA prescribed first-line to third-line ustekinumab or TNFi. Drug persistence, effectiveness (achievement of clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) low disease activity (LDA)/remission and minimal disease activity/very low disease activity (MDA/VLDA)), and safety were assessed every 6 months. In addition to descriptive statistics, propensity score (PS)-adjusted comparisons across cohorts were performed.

Results: At 1 year, overall persistence was similar in the ustekinumab (n=317/438, 72.4%) and TNFi (n=321/455, 70.5%) groups. PS-adjusted HR (95% CI) for stopping/switching ustekinumab versus TNFi was 0.82 (0.60; 1.13). cDAPSA LDA (including remission)/remission was achieved in 55.9%/22.1% of ustekinumab-treated and 67.1%/31.7% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.80 (0.57; 1.10) for cDAPSA LDA and 0.73 (0.49; 1.07) for remission. MDA/VLDA was achieved in 34.2%/11.9% of ustekinumab-treated and 43.1%/12.6% of TNFi-treated patients; PS-adjusted ORs (95% CI) were 0.89 (0.63; 1.26) for MDA and 0.90 (0.54; 1.49) for VLDA. The safety profiles were similar in both groups.

Conclusion: In the real-world PsABio Study, after 1 year of treatment, although unadjusted persistence was numerically slightly higher for ustekinumab versus TNFi and unadjusted effectiveness was numerically slightly higher for TNFi versus ustekinumab, the PS-adjusted comparisons demonstrated comparable overall persistence, effectiveness and safety for both modes of action in PsA.

Keywords: arthritis; biological therapy; psoriatic; tumor necrosis factor inhibitors.

Conflict of interest statement

Competing interests: LG reports research grants from: Amgen, Galapagos, Lilly, Pfizer, Sandoz, Sanofi; consulting fees from: AbbVie, Amgen, Bristol-Myers Squibb, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB. SS reports non-financial support from Janssen during the conduct of the study; grants from: Boehringer-Ingelheim, Bristol-Myers Squibb; personal fees from: AbbVie, Biogen, Novartis; grants and personal fees from: Amgen (previously Celgene), GlaxoSmithKline, Janssen, UCB; all outside the submitted work. PB is a full-time employee of Janssen and owns stock at Johnson & Johnson. KdV reports personal fees from Janssen. EG reports payment or honoraria from AbbVie, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Novartis, Pfizer, Sanofi. BJI has nothing to disclose. TVK reports consulting fees from MCD, Pfizer, Janssen, BiOCAD, AbbVie, Novartis, Sandoz, Lilly. FL reports non-financial support, full-time employment and restricted share units from Janssen during the conduct of the study. WN is a full-time employee of and owns stock at Johnson & Johnson. MTN reports grants and non-financial support from Janssen during the conduct of the study; grants from: Bristol-Myers Squibb, Amgen, Pfizer; grants and personal fees from: AbbVie, Eli Lilly; all outside the submitted work. PPS reports non-financial support from Janssen during the conduct of the study; grants from: UCB; personal fees from: Merck Sharpe & Dohme; grants and personal fees from: AbbVie, Lilly, Pfizer, Novartis; all outside the submitted work. ET is a full-time employee of Janssen. JSS reports grants to his institution from: AbbVie, Astro, AstraZeneca, Janssen, Lilly, Merck Sharpe & Dohme, Pfizer, and Roche; providing expert advice for or had symposia speaking engagements with: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO Pharma, Janssen, Lilly, Merck Sharp & Dohme, Novartis-Sandoz, Pfizer, R-Pharm, Roche, Samsung, Sanofi, and UCB.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

Kaplan-Meier plots of treatment persistence with ustekinumab versus TNFi (A) Overall, (B) By sex, (C) By treatment line, (D) By presence/absence of methotrexate and (E) By extent of skin involvement at baseline. BSA, body surface area; MTX, methotrexate; TNFi, tumour necrosis factor inhibitor; UST, ustekinumab.

Figure 2

Disease outcomes at month 12 for patients with PsA receiving ustekinumab or TNFi. *Main (solid) bar represents cDAPSA LDA (including remission; cDAPSA ≤13) and inset (hashed) bar represents cDAPSA remission ≤4. †Main (solid) bar represents MDA (including VLDA) and inset (hashed) bar represents VLDA. cDAPSA, clinical disease activity in psoriatic arthritis; LDA, low disease activity; MDA, minimal disease activity; PsA, psoriatic arthritis; TNFi, tumour necrosis factor inhibitor; VLDA, very low disease activity.

Figure 3

Proportion of patients achieving MDA at month 6 (observed) and month 12 (LOCF) and PS-adjusted ORs. *The 6-month PS-adjusted OR 95% CI are from the 6-month analysis. LOCF, last observation carried forward; MDA, minimal disease activity; mo, month; obs, observed; PS, propensity score.

Figure 4

Mean PsAID-12 overall and domain scores at baseline and 1 year with ustekinumab (n=438) and TNFi (n=455). UST: mean (95% CI) total score improved from 5.8 (5.5; 6.0) at baseline to 3.9 (3.6; 4.1) at 6 months and 3.7 (3.4; 3.9) at 1 year. TNFi: mean (95% CI) total score improved from 5.5 (5.3; 5.7) at baseline to 3.4 (3.2; 3.7) at 6 months and 3.1 (2.9; 3.4) at 1 year. LOCF, last observation carried forward; PsA, psoriatic arthritis; PsAID-12, 12-item Psoriatic Arthritis Impact of Disease; TNFi, tumour necrosis factor inhibitor; UST, ustekinumab.