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Abstract Number: 1546

Patient-Reported Outcomes of Etanercept in Early Non-Radiographic Axial Spondyloarthritis: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial

Maxime Dougados1, Wen-Chan Tsai2, Diego Luis Saaibi3, Randi Bonin4, Jack Bukowski5, Ronald Pedersen6, Bonnie Vlahos7 and Sameer Kotak8, 1Rheumatology B Department, Paris-Descartes University, APHP, Cochin Hospital, Paris, France, 2Chung-Ho Memorial Hospital, Kaohsiung, 807, Taiwan, 3MEDICITY S.A.S, Bucaramanga, Santander 681001, Colombia, 4Pfizer Inc, Collegeville, PA, 5Department of Specialty Care, Pfizer Inc, Collegeville, PA, 6Specialty Care, Pfizer Inc, Collegeville, PA, 7Department of Specialty Care, Pfizer Inc., Collegeville, PA, 8Specialty Care, Pfizer Inc., New York, NY

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: etanercept, patient outcomes, randomized trials and spondylarthritis

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Session Information

Title: Spondylarthropathies and Psoriatic Arthritis: Clinical Aspects and Treatment: II

Session Type: Abstract Submissions (ACR)

Background/Purpose: Limited data are available on the efficacy of anti-TNF agents in non-radiographic axial spondyloarthritis (nr-axSpA). This analysis compares the impact of etanercept (ETN) vs placebo (PBO) on patient-reported outcomes (PROs), after 12 weeks of double-blind treatment in patients (pts) with nr-axSpA who had an insufficient response to NSAIDs.

Methods: Enrolled pts satisfied ASAS criteria for axSpA, had symptom duration of 3 months-5 years and a BASDAI score ≥4 despite current NSAID use. Pts were randomized to ETN 50 mg weekly or PBO with concomitant background NSAIDs. The primary clinical endpoint was ASAS40 at week 12. PROs included BASDAI, BASFI, BAS-G, Work Productivity and Activity Index-Ankylosing Spondylitis (WPAI-AS), Multidimensional Fatigue Inventory (MFI), Nocturnal back pain VAS, total back pain VAS, subject assessment of disease activity (SGA), Short Form (SF-36), Medical Outcomes Study (MOS)-Sleep, Patient Acceptable Symptom State (PASS), Minimal Clinically Important Improvement (MCII), EuroQol (EQ)-5D and Hospital Anxiety and Depression Screening (HADS). ANCOVA models were used with baseline score, treatment, region and SI status as variables. LOCF was used for missing data.

Results: At baseline, MFI general scores (14.7, 15.0 [ETN, PBO]), EQ-5D utility scores (0.52, 0.57), EQ-5D VAS scores (56.5, 56.4) and MOS Sleep Index II scores (45.5, 48.1) were worse than population norms (6.6-8.01, 0.862, 82.53 and 25.84, respectively). By week 12, more pts achieved ASAS40 with ETN50 than PBO (32% vs. 16%, P=0.006).5 By week 12 significant improvements favoring ETN50 vs. PBO were seen in stiffness, joint pain, ease of standing from an armless chair, ease of physically demanding and full-day activities, looking over the shoulder, reaching up high, putting on socks and SGA (p<0.05 for all, Table). Mean WPAI presenteeism, SF-36 bodily pain and MOS-sleep quantity favored ETN50 (P<0.05), as did the proportion of pts with MCII (p=0.0458). Non-significant improvements for ETN50 vs. PBO were seen in bending forward from the waist, WPAI, MFI, MOS-Sleep Problems Index I and II, HADS, EQ-5D and SF-36 total scores (P>0.05 for all).

Conclusion: The data show substantial improvements in PRO measures for disease specific and functional domains such as BASDAI, BASFI, BAS-G, and pain, but limited improvement on general PRO measures such as sleep, fatigue and general health. Short disease duration, a short placebo-controlled period, and a wide range of PRO scores at baseline may have influenced relative improvements.

                                                                            

Table. Improvements from baseline to week 12 in PROs (observed cases), adjusted mean change (95% CI)

 

ETN50 + NSAID

(n=106)

PBO + NSAID
(n=109)

BASDAI PRO

 

 

Duration of morning stiffness

-2.05 (-2.67, -1.44)†

-0.84 (-1.43, -0.25)†

Severity of morning stiffness

-2.30 (-3.01, -1.60)†

-1.39 (-2.06, -0.72)†

Severity of pain in the neck/back/hip

-2.46 (-3.19, -1.74)†

-1.48 (-2.17, -0.80)†

Severity of pain in joints other than neck/back/hip

-1.37 (-2.06, -0.69)*

-0.69 (-1.34, -0.03)*

BASFI

 

 

Ease of bending forward from the waist

-1.26 (-1.85, -0.67)

-0.72 (-1.28, -0.16)

Ease of standing from an armless chair

-1.80 (-2.37, -1.22)†

-0.95 (-1.50, -0.40)†

Ease of doing a full day of activities

-2.16 (-2.75, -1.56)†

-1.13 (-1.70, -0.56)†

Ease of looking over your shoulder

-1.48 (-2.06, -0.90)*

-0.85 (-1.40, -0.29)*

Ease of physically demanding activities

-1.65 (-2.24, -1.06)†

-0.81 (-1.37, -0.25)†

Ease of reaching up high

-0.60 (-1.15, -0.06)*

-0.06 (-0.58, 0.46)*

Ease of putting on socks

-1.08 (-1.64, -0.51)*

-0.51 (-1.05, 0.03)*

BAS-G total

-1.88 (-2.44, -1.33)*

-1.29 (-1.82, -0.77)*

BAS-G (since last week)

-2.00  (-2.66, -1.34)*

-1.20 (-1.83, -0.57)*

Nocturnal back pain VAS

-2.00 (-2.75, -1.26)†

-0.93 (-1.63, -0.22)†

Total back pain VAS

-2.00 (-2.67, -1.33)†

-1.03 (-1.67, -0.40)†

Average back pain VAS

-2.01 (-2.70, -1.32)†

-0.98 (-1.64, -0.32)†

Subject assessment of disease activity

-2.12 (-2.76, -1.47)†

-1.19 (-1.81, -0.58)†

*P <0.05 for ETN50 vs. PBO at week 12; †P<0.01 for ETN50 vs. PBO at week 12.

1. Schwarz, R., et al. Onkologie, 2003. 26(2): p. 140-4. 2. Dolan, P., Med Care, 1997. 35(11): p. 1095-108. 3. Kind, P., G. Hardman, and S. Marcran, eds., Centre for Health Economics, University of York: York. 4. Hays, R.D., et al., Sleep Med, 2005. 6(1): p. 41-4; 5. Dougados M. et al. Ann Rheum Dis. 2013; 72 (suppl. 3): Abstract #21799

 


Disclosure:

M. Dougados,

Pfizer Inc,

5,

Pfizer Inc,

2;

W. C. Tsai,
None;

D. L. Saaibi,
None;

R. Bonin,

Pfizer Inc,

1,

Pfizer Inc,

3;

J. Bukowski,

Pfizer Inc,

1,

Pfizer Inc,

3;

R. Pedersen,

Pfizer Inc,

3;

B. Vlahos,

Pfizer Inc,

1,

Pfizer Inc,

3;

S. Kotak,

Pfizer Inc,

1,

Pfizer Inc,

3.

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