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Observational Study
. 2024 Sep 20;10(3):e004318.
doi: 10.1136/rmdopen-2024-004318.

Comparative early effectiveness across 14 PsA drugs and 5 classes of PsA treatment: 3-month results from the PRO-SPIRIT study

Lars Erik Kristensen  1 , Khai Jing Ng  2 , Marcus Ngantcha  2 , Jacques Morel  3   4 , Ennio Lubrano  5 , William Tillett  6 , Rieke Alten  7 , Vinod Chandran  8 , Àngels Martinez Ferrer  9 , Baojin Zhu  2 , Dominika Kennedy  2 , Thorsten Holzkämper  2 , Nicola Gullick  10   11 , Andris Kronbergs  2 , Walid Fakhouri  2 , Inmaculada de la Torre  2 , Dennis G McGonagle  12
Affiliations
Observational Study

Comparative early effectiveness across 14 PsA drugs and 5 classes of PsA treatment: 3-month results from the PRO-SPIRIT study

Lars Erik Kristensen et al. RMD Open. .

Abstract

Background: The psoriatic arthritis (PsA) Observational Study of Persistence of Treatment (PRO-SPIRIT) assesses effectiveness and persistence of real-world PsA treatments. Ixekizumab (IXE) is an interleukin (IL)-17A inhibitor (i) (IL-17Ai), approved for the treatment of adult PsA.

Methods: The aim of this predefined interim analysis was to report baseline characteristics along with early (3-month) descriptive and comparative real-world effectiveness in patients with PsA prescribed with advanced treatment including IL-17Ai; IXE or secukinumab (SEC), IL-12/23i, IL-23i, tumour necrosis factor (TNFi) or Janus kinase (JAKi).

Results: 1192 patients across 6 countries were analysed. At baseline, patients receiving IXE had longer disease duration and higher previous biological/targeted-synthetic disease-modifying antirheumatic drugs experience than patients starting TNFi and SEC 150, and less concomitant conventional-synthetic DMARD use than TNFi and JAKi. Comparative analyses at 3 months showed that: (a) versus TNFi, IXE exhibited similar improvement in clinical Disease Activity in PsA (cDAPSA) but significantly greater improvement in body surface area affected by psoriasis (BSA) and global assessments (physician GA, patient GA (PatGA)); (b) versus IL-12/23i and IL-23i (pooled), IXE showed significantly greater improvement in cDAPSA and PatGA; (c) IXE was as fast as JAKi in improving joint disease activity. Ad hoc analysis indicated that more patients with active psoriasis (BSA ≥3%) achieved minimal disease activity with IXE than JAKi or IL-12/23i. The responses to SEC varied by dosage.

Conclusions: This study confirms the rapid 3-month effectiveness of IXE on joint disease activity-as fast as TNFi and JAKi (cDAPSA), and exceeding IL-12/23i and IL-23i-along with clear benefits to skin.

Keywords: arthritis, psoriatic; health-related quality of life; interleukin-17; patient reported outcome measures; tumor necrosis factor inhibitors.

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Conflict of interest statement

Competing interests: LEK has received honoraria or fees for serving as a speaker or consultant from AbbVie, Amgen, Biogen, Bristol Myers Squibb, Eli Lilly and Company, Gilead, GSK, Janssen, Merck, Novartis, Pfizer and UCB. He has received investigator-initiated study grants from AbbVie, Biogen, Eli Lilly and Company, Janssen, Novartis, Pfizer and UCB. KJN and MN are employees and minor shareholders of Eli Lilly and Company. JM has received grants, speaker honoraria or travel support, or participated on an advisory board for AbbVie, Biogen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly and Company, Fresenius Kabi, Galapagos, Medac, Mylan, Novartis, Pfizer, Roche Chugaï, Sanofi and Viatris. EL has received speaker honoraria from AbbVie, Eli Lilly and Company, Janssen, Novartis and UCB. WT has received grants, consulting fees, speaker honoraria and/or travel support from AbbVie, Eli Lilly and Company, GSK, Janssen, Novartis, Ono-Pharma, Pfizer and UCB. RA has received consulting fees, speaker honoraria and/or travel support from AbbVie, Amgen, Bristol Myers Squibb, Celltrion, Eli Lilly and Company, Galapagos, Gilead, Janssen, Mylan, Novartis, Pfizer, Roche Chugaï, Viatris and UCB. VC has received grants, royalties or consulting fees, or had a leadership role in, AbbVie, Amgen, Bristol Myers Squibb, Canadian Psoriasis Network, Eli Lilly and Company, Fresenius Kabi, Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), Janssen, Novartis, UCB and University Health Network. AMF has received speaker honoraria, payment for expert testimony and/or travel support from AbbVie, Eli Lilly and Company, Janssen, Pfizer, Novartis and UCB. BZ, DK and TH are employees and minor shareholders of Eli Lilly and Company. NG has received grants, consulting fees, speaker honoraria, travel support or equipment/services, or participated on an advisory board for AbbVie, AstraZeneca, Eli Lilly and Company, Galapagos, Janssen, Novartis and UCB. AK, WF and IdlT are employees and minor shareholders of Eli Lilly and Company. DGMcG has received consulting fees, speaker honoraria, research grant support and/or travel support from AbbVie, Almiral, Bristol Myers Squibb, Eli Lilly and Company, Janssen, Novartis, Pfizer and UCB.

Figures

Figure 1
Figure 1. Baseline-adjusted change from baseline in mean cDAPSA scores of the full study sample (n=1192) (descriptive, adjusted for baseline differences in mean cDAPSA). All data presented as mean (95% CI). Adjusted for between-group comparison through the use of MMRM to account for baseline differences in mean cDAPSA. SEC 150 (n=87; mean (95% CI)=−10.99% (−13.58% to −8.40%)) and SEC 300 (n=79; −8.01% (−10.75% to −5.27%)) pooled together for data visualisation purposes. cDAPSA, clinical disease activity in psoriatic arthritis; i, inhibitor; IL, interleukin; IXE, ixekizumab; JAKi, Janus kinase inhibitor; MMRM, mixed model for repeated measures; PsA, psoriatic arthritis; SEC, secukinumab; TNF, tumour necrosis factor.
Figure 2
Figure 2. Baseline-adjusted change from baseline in mean affected BSA of the full study sample (n=1192) (descriptive, adjusted for baseline differences in mean BSA). All data presented as mean (95% CI). Adjusted for between-group comparison through the use of MMRM to account for baseline differences in mean BSA. SEC 150 (n=87; mean (95% CI)=−2.68% (−3.87% to −1.48%)) and SEC 300 (n=79; −2.69% (−3.97% to −1.42%)) pooled together for data visualisation purposes. BSA, body surface area; i, inhibitor; IL, interleukin; IXE, ixekizumab; JAKi, Janus kinase inhibitor; MMRM, mixed model for repeated measures; PsA, psoriatic arthritis; SEC, secukinumab; TNF, tumour necrosis factor.
Figure 3
Figure 3. Forest plots depicting comparative assessment (least squares mean difference (TJC, SJC, cDAPSA, BSA, PhysGA, PatGA, HAQ-DI, Pain VAS) or OR (MDA)) of early response to treatment (3 months after initiation) in the full sample of patients with real-world psoriatic arthritis (n=1192). All data presented as LSM difference (TJC, SJC, cDAPSA, BSA, PhysGA, PatGA, HAQ-DI and Pain VAS) or OR (MDA) and 95% CI. Adjusted for between-group comparison through the use of IPTW to account for all baseline differences. Secukinumab 150 mg: n=87; secukinumab 300 mg: n=79. BSA, body surface area; cDAPSA, clinical disease activity in psoriatic arthritis; HAQ-DI, Health Assessment Questionnaire-Disability Index; i, inhibitor; IPTW, inverse probability of treatment weighting; LSM, least squares mean; MDA, minimal disease activity; PatGA, patient global assessment; PhysGA, physician global assessment; SJC, swollen joint count; TJC, tender joint count; TNF, tumour necrosis factor; VAS, visual analogue scale.
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