Ixekizumab improves patient-reported outcomes up to 52 weeks in bDMARD-naive patients with active psoriatic arthritis (SPIRIT-P1)

被引:26
|
作者
Gottlieb, Alice B. [1 ]
Strand, Vibeke [2 ]
Kishimoto, Mitsumasa [3 ]
Mease, Philip [4 ,5 ]
Thaci, Diamant [6 ]
Birt, Julie [7 ]
Lee, Chin H. [7 ,9 ]
Shuler, Catherine L. [7 ]
Lin, Chen-Yen [7 ]
Gladman, Dafna D. [8 ]
机构
[1] New York Med Coll, Metropolitan Hosp, Dept Dermatol, 1901 First Ave, New York, NY 10029 USA
[2] Stanford Univ, Div Immunol Rheumatol, Palo Alto, CA 94304 USA
[3] St Lukes Int Hosp, Immunorheumatol Ctr, Tokyo, Japan
[4] Univ Washington, Dept Rheumatol, Swedish Med Ctr, Seattle, WA 98195 USA
[5] Univ Washington, Div Rheumatol, Seattle, WA 98195 USA
[6] Univ Hosp Schleswig Holstein, Comprehens Ctr Inflammat Med, Campus Lubeck, Lubeck, Germany
[7] Eli Lilly & Co, Indianapolis, IN 46285 USA
[8] Univ Toronto, Dept Med, Div Rheumatol, Krembil Res, Toronto, ON, Canada
[9] Genentech Inc, 1 DNA Way, San Francisco, CA 94080 USA
关键词
DMARDs (biologic); psoriatic arthritis; treatment; outcomes research; ixekizumab; QUALITY-OF-LIFE; TO-SEVERE PSORIASIS; EULAR RECOMMENDATIONS; DOUBLE-BLIND; ETANERCEPT TREATMENT; MONOCLONAL-ANTIBODY; RHEUMATIC-DISEASES; CLINICAL-TRIALS; PHASE-3; TRIAL; 2015; UPDATE;
D O I
10.1093/rheumatology/key161
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objective. To report patient-reported outcomes of patients with PsA treated with ixekizumab up to 52 weeks. Methods. In SPIRIT-P1, biologic-naive patients with active PsA were randomized to ixekizumab 80 mg every 4 weeks (IXEQ4W; N= 107) or every 2 weeks (IXEQ2W; N= 103) following a 160 mg starting dose, adalimumab 40 mg every 2 weeks (ADA; N= 101) or placebo (PBO; N= 106) during the initial 24-week double-blind treatment period. At week 24 (week 16 for inadequate responders), ADA (8-week washout before starting ixekizumab) and PBO patients were re-randomized to IXEQ2W or IXEQ4W. Patients receiving ixekizumab at week 24 received the same dose during the extension period (EP) to week 52. Patients completed measures including the Dermatology Life Quality Index (DLQI), Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2, European Quality of Life 5 Dimensions Visual Analogue Scale and Work Productivity and Activity Impairment Questionnaire-Specific Health Problem. Results. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in DLQI at week 24; 22% (PBO), 53% (IXEQ4W), 63% (IXEQ2W) and 54% (ADA) of patients reported DLQI scores of 0/1. The IXEQ4W, IXEQ2W and ADA groups reported significant improvements in Itch Numeric Rating Scale, 36-Item Short Form Health Survey version 2 physical component summary and some domain scores, and European Quality of Life 5 Dimensions Visual Analogue Scale at weeks 12 and 24; and in three of four Work Productivity and Activity Impairment Questionnaire-Specific Health Problem domains at week 24. Results are also presented through week 52 for the EP. Conclusion. In biologic-naive patients with active PsA, ixekizumab significantly improved skin symptoms, health-related quality of life and work productivity.
引用
收藏
页码:1777 / 1788
页数:12
相关论文
共 50 条
  • [21] Golimumab Improves Patient-Reported Outcomes In Patients With Active Rheumatoid Arthritis
    Dasgupta, B.
    Bertin, P.
    Settas, L.
    Fonseca, J. E.
    Wolff, V.
    Yao, R.
    Govoni, M.
    Vastesaeger, N.
    Weng, H. H.
    ARTHRITIS AND RHEUMATISM, 2013, 65 : S209 - S209
  • [22] EFFICACY OF IXEKIZUMAB IMPROVING SF-36 SCORES IN BIOLOGIC DMARD-NAIVE PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS: RESULTS FROM A PHASE 3 STUDY (SPIRIT-P1)
    Strand, V.
    Gottlieb, A. B.
    Kvien, T. K.
    Naegeli, A.
    Lin, C-Y.
    Benichou, O.
    Birt, J.
    ANNALS OF THE RHEUMATIC DISEASES, 2017, 76 : 1334 - 1335
  • [23] Ixekizumab provides improvements through 52 weeks in physical function, quality of life, and work productivity in biologic diseasemodifying antirheumatic drug (bDMARD) naive patients with active psoriatic arthritis (PsA)
    Gottlieb, A. B.
    Husni, M. E.
    Shuler, C. L.
    Burge, R.
    Lin, C. -Y.
    Lee, C. H.
    Gladman, D. D.
    JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2016, 30 : 4 - 4
  • [24] Efficacy and safety of ixekizumab in patients with active psoriatic arthritis: 52-week results from a phase III study (SPIRIT-P1) (vol 45, pg 367, 2018)
    Van der Heijde, D.
    Gladman, D. D.
    Kishimoto, M.
    Okada, M.
    Rathmann, S. S.
    Moriarty, S. R.
    Shuler, C. L.
    Carlier, H.
    Benichou, O.
    Mease, P. J.
    JOURNAL OF RHEUMATOLOGY, 2018, 45 (11) : 1608 - 1608
  • [25] Fifty two-week efficacy and safety results from SPIRIT-P1: A Phase 3 study of ixekizumab in patients with active psoriatic arthritis
    Mease, P.
    Okada, M.
    Kishimoto, M.
    Shuler, C.
    Carlier, H.
    Lin, C.
    Mou, J.
    Moriarty, S. R.
    Lee, C.
    Gladman, D.
    Satler, M.
    JOURNAL OF INVESTIGATIVE DERMATOLOGY, 2017, 137 (10) : S260 - S260
  • [26] Fifty two-week efficacy and safety results from SPIRIT-P1: a Phase 3 study of ixekizumab in patients with active psoriatic arthritis
    Mease, P.
    Okada, M.
    Kishimoto, M.
    Shuler, C.
    Carlier, H.
    Lin, C. -Y.
    Mou, J.
    Moriarty, S.
    Lee, C.
    Gladman, D.
    JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY, 2016, 30 : 32 - 33
  • [27] The effect of ixekizumab on axial manifestations in patients with psoriatic arthritis from two phase III clinical trials: SPIRIT-P1 and SPIRIT-P2
    Deodhar, Atul
    Gladman, Dafna
    Bolce, Rebecca
    Sandoval, David
    Park, So Young
    Leage, Soyi Liu
    Nash, Peter
    Poddubnyy, Denis
    THERAPEUTIC ADVANCES IN MUSCULOSKELETAL DISEASE, 2023, 15
  • [28] EFFICACY OF IXEKIZUMAB IN ACTIVE PSORIATIC ARTHRITIS (PSA) PATIENTS WITH AXIAL PAIN STARTING BEFORE AGE 45: A SUBGROUP ANALYSIS OF SPIRIT-P1 AND SPIRIT-P2 PHASE 3 CLINICAL TRIALS
    Deodhar, Atul
    Ogdie, Alexis
    Muram, Talia
    Sandoval, David
    Geneus, Vladimir
    Nash, Peter
    ANNALS OF THE RHEUMATIC DISEASES, 2019, 78 : 1838 - 1838
  • [29] Bimekizumab efficacy and safety in biologic bDMARD-naive patients with psoriatic arthritis was consistent with or without methotrexate: 52-week results from the phase 3 active reference study BE OPTIMAL
    McInnes, I.
    Mease, P.
    Tanaka, Y.
    Behrens, F.
    Gossec, L.
    Husni, M.
    Kristensen, L.
    Warren, R.
    Ink, B.
    Bajracharya, R.
    Coarse, J.
    Eells, J.
    Gottlieb, A.
    SCANDINAVIAN JOURNAL OF RHEUMATOLOGY, 2023, 52 : 78 - 81
  • [30] IXEKIZUMAB IMPROVES NAIL AND SKIN LESIONS THROUGH 52 WEEKS IN PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS AND INADEQUATE RESPONSE TO TUMOUR NECROSIS FACTOR INHIBITORS
    Merola, J. F.
    Rich, P.
    Dutz, J. P.
    Adams, D.
    Kerr, L.
    Kristensen, L. E.
    ANNALS OF THE RHEUMATIC DISEASES, 2018, 77 : 374 - 375