Session Information
Session Type: Abstract Submissions (ACR)
Background/Purpose: To assess the treatment effect of ustekinumab on fatigue using data from PSUMMIT 2.
Methods: Adult patients with active psoriatic arthritis (PsA) despite DMARD (N=132) and/or previous treatment with biologics (N=180) were randomized to receive ustekinumab 45mg, 90mg, or placebo (PBO) at wks 0, 4, and q12wks thereafter through week 40. PBO-treated patients crossed over to receive ustekinumab 45mg at weeks 24, 28 and q12wks through week 40. Fatigue was measured using the Functional Assessment of Chronic Illness Therapy‐Fatigue (FACIT-Fatigue, 0-52) and the vitality scales of SF-36 health survey questionnaire (SF-36 VT, 0-100). High scores indicate low severity in fatigue. Clinically meaningful improvement was defined as ≥4 point increase in FACIT-Fatigue or ≥3 point increase in SF-36 VT score from baseline. Disease activity was measured by disease activity score using 28 joints (DAS28), and physical function was measured using Health Assessment Questionnaire (HAQ).
Results:
At baseline, patients had a mean FACIT-Fatigue score of 25.8 and had a mean SF-36 VT score of 36.9, which was significantly below the values of the U.S. normal population (50), indicating severe fatigue. Both FACIT-Fatigue and SF-36 VT scores were significantly correlated with DAS28 (r=0.42, 0.38, respectively) and HAQ (r=0.62, 0.51, respectively) at baseline, and the improvements in FACIT-Fatigue and SF-36 VT scores were significantly correlated with improvement in DAS28 (r=0.45, 0.43, respectively) and improvement in HAQ scores (r=0.43, 0.41, respectively) at week 24. At week 24, patients who received ustekinumab achieved statistically significantly greater improvement in FACIT-Fatigue score (4.35 vs. 0.86, p=0.002) and in SF-36 VT score (3.87 vs. 0.67, p=0.004) compared with PBO. Compared to PBO, a greater proportion of ustekinumab-treated patients achieved a clinically meaningful improvement in FACIT-Fatigue (49% vs. 25.5%) or SF-36 VT (45% vs. 29.9%) (all p<0.01). No significant differences were observed between the ustekinumab 45 and 90mg groups. The treatment effect on fatigue was consistent across biologically-experienced and DMARD-experienced patients, and maintained through week 52. Patients who were randomized to PBO and switched to active treatment at week 24 achieved comparable improvement at week 52.
Conclusion: Ustekinumab therapy significantly reduces the symptom of fatigue in patients with active PsA. Clinically meaningful improvement in fatigue was observed within 3 doses of ustekinumab therapy.
Disclosure:
C. T. Ritchlin,
Amgen, Janssen, and UCB ,
2,
Abbott, Amgen, Janssen, Regeneron, Roche, and UCB,
5;
P. Rahman,
Abbott, Amgen, Janssen, Merck/Schering-Plough, and Wyeth,
2;
L. Puig Sanz,
Abbott, Amgen, Celgene, Janssen Research & Development, LLC., Merck/Schering-Plough, and Pfizer,
2;
A. B. Gottlieb,
Amgen, Astellas, Akros, Celgene, BMS, Beiesrdorf, AbbVie,Janssen, TEVA, Actelion, UCB, Novo Nordisk, Novartis, Dermipsor, Incyte, Pfizer, Canfite, Lilly, Coronado, Vertex, Karyopharm, CSL Behring Biotherapies for Life, GSK, Xenoport, Catabasis, Sanofi Ave,
5,
Janssen, Amgen, AbbVie, Novartis, Celgene, Pfizer, Lilly, Coronado, Levia, Merck,
2;
A. Kavanaugh,
AbbVie,
2,
Amgen,
2,
Roche Pharmaceuticals,
2,
Pfizer Inc,
2,
Janssen Pharmaceutica Product, L.P.,
2,
UCB,
2,
BMS,
2,
Astellas,
2;
I. B. McInnes,
Pfizer Inc,
2,
UCB,
2,
Pfizer Inc,
5,
Janssen Pharmaceutica Product, L.P.,
5,
UCB,
5,
BMS,
5,
Abbvie,
5,
Astra Zeneca,
5;
S. Li,
Janssen Research & Development, LLC.,
3,
Johnson & Johnson,
1;
Y. Wang,
Janssen Research & Development, LLC.,
3;
R. Ganguly,
Janssen Global Services, LLC.,
3;
A. M. Mendelsohn,
Janssen Research & Development, LLC.,
3;
C. Han,
Janssen Global Services, LLC.,
3.
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/treatment-effect-of-ustekinumab-on-fatigue-in-patients-with-psoriatic-arthritis-results-from-a-phase-3-clinical-trial/