Evaluation of Health Outcomes with Etanercept Treatment in Patients with Early Nonradiographic Axial Spondyloarthritis.
Analyses were conducted to examine the baseline burden of illness and compare the effect of etanercept (ETN) versus placebo (PBO) on quality of life (QOL) in patients with nonradiographic axial spondyloarthritis (nr-axSpA) who failed nonsteroidal antiinflammatory drugs (NSAID).



Patients fulfilling the Assessment of Spondyloarthritis International Society axSpA criteria, not meeting the modified New York criteria for ankylosing spondylitis (AS), who were symptomatic 3 months to 5 years, with a Bath AS Disease Activity Index score ≥ 4, and failed ≥ 2 NSAID were randomized to ETN 50 mg weekly or PBO (double-blind) for 12 weeks, followed by open-label ETN 50 mg for 92 weeks. Stable NSAID were allowed throughout our study. QOL outcomes over 24 weeks were analyzed using ANCOVA models.



At baseline, Multidimensional Fatigue Inventory (MFI; ETN mean 14.7, PBO mean 15.0), EQ-5D utility (0.52, 0.57), EQ-5D visual analog scale (56.5, 56.4), and Medical Outcomes Study (MOS) Sleep Index II (45.5, 48.1) were worse than population norms (6.6-8.0, 0.86, 82.5, and 25.8, respectively). At Week 12, Bath AS Patient Global Score, nocturnal and average back pain, MOS Short Form-36 (SF-36) physical component, and Work Productivity and Activity Index (WPAI) presenteeism and activity impairment favored ETN (p < 0.05). Nonsignificant improvements for ETN were seen in other WPAI domains, MFI, MOS-Sleep Index I and II, Hospital Anxiety and Depression Scale, EQ-5D utility score, and SF-36 mental component (p > 0.05). At Week 24, patients in the PBO group who had switched to ETN at Week 12 showed improvement in most QOL assessments, similar to that seen in patients receiving ETN for 24 weeks.



Improvements favored ETN in QOL and productivity measures, with limited improvement on general QOL measures. Short disease duration, a short PBO-controlled period, and a wide range of QOL scores at baseline may have influenced improvements.
From the Paris Descartes University, Cochin Hospital, Paris, France; Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Medicity S.A.S., Bucaramanga, Colombia; Pfizer, Collegeville, Pennsylvania; Pfizer, New York, New York, USA.M. Dougados, MD, President, Clinical Epidemiology and Biostatistics, Paris Descartes University, Cochin Hospital; W.C. Tsai, MD, Division of Rheumatology, Chung-Ho Memorial Hospital; D.L. Saaibi, MD, Medicity S.A.S.; R. Bonin, BS; J. Bukowski, MS, PhD; R. Pedersen, MS; B. Vlahos, MBA, BSN, RN, Director; S. Kotak, MS, MBA, Inflammation and Immunology, Pfizer. maxime.dougados@cch.aphp.fr.
Maxime
M
Dougados
From the Paris Descartes University, Cochin Hospital, Paris, France; Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Medicity S.A.S., Bucaramanga, Colombia; Pfizer, Collegeville, Pennsylvania; Pfizer, New York, New York, USA.M. Dougados, MD, President, Clinical Epidemiology and Biostatistics, Paris Descartes University, Cochin Hospital; W.C. Tsai, MD, Division of Rheumatology, Chung-Ho Memorial Hospital; D.L. Saaibi, MD, Medicity S.A.S.; R. Bonin, BS; J. Bukowski, MS, PhD; R. Pedersen, MS; B. Vlahos, MBA, BSN, RN, Director; S. Kotak, MS, MBA, Inflammation and Immunology, Pfizer.
Wen-Chan
WC
Tsai
From the Paris Descartes University, Cochin Hospital, Paris, France; Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Medicity S.A.S., Bucaramanga, Colombia; Pfizer, Collegeville, Pennsylvania; Pfizer, New York, New York, USA.M. Dougados, MD, President, Clinical Epidemiology and Biostatistics, Paris Descartes University, Cochin Hospital; W.C. Tsai, MD, Division of Rheumatology, Chung-Ho Memorial Hospital; D.L. Saaibi, MD, Medicity S.A.S.; R. Bonin, BS; J. Bukowski, MS, PhD; R. Pedersen, MS; B. Vlahos, MBA, BSN, RN, Director; S. Kotak, MS, MBA, Inflammation and Immunology, Pfizer.
Diego L
DL
Saaibi
From the Paris Descartes University, Cochin Hospital, Paris, France; Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Medicity S.A.S., Bucaramanga, Colombia; Pfizer, Collegeville, Pennsylvania; Pfizer, New York, New York, USA.M. Dougados, MD, President, Clinical Epidemiology and Biostatistics, Paris Descartes University, Cochin Hospital; W.C. Tsai, MD, Division of Rheumatology, Chung-Ho Memorial Hospital; D.L. Saaibi, MD, Medicity S.A.S.; R. Bonin, BS; J. Bukowski, MS, PhD; R. Pedersen, MS; B. Vlahos, MBA, BSN, RN, Director; S. Kotak, MS, MBA, Inflammation and Immunology, Pfizer.
Randi
R
Bonin
From the Paris Descartes University, Cochin Hospital, Paris, France; Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Medicity S.A.S., Bucaramanga, Colombia; Pfizer, Collegeville, Pennsylvania; Pfizer, New York, New York, USA.M. Dougados, MD, President, Clinical Epidemiology and Biostatistics, Paris Descartes University, Cochin Hospital; W.C. Tsai, MD, Division of Rheumatology, Chung-Ho Memorial Hospital; D.L. Saaibi, MD, Medicity S.A.S.; R. Bonin, BS; J. Bukowski, MS, PhD; R. Pedersen, MS; B. Vlahos, MBA, BSN, RN, Director; S. Kotak, MS, MBA, Inflammation and Immunology, Pfizer.
Jack
J
Bukowski
From the Paris Descartes University, Cochin Hospital, Paris, France; Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Medicity S.A.S., Bucaramanga, Colombia; Pfizer, Collegeville, Pennsylvania; Pfizer, New York, New York, USA.M. Dougados, MD, President, Clinical Epidemiology and Biostatistics, Paris Descartes University, Cochin Hospital; W.C. Tsai, MD, Division of Rheumatology, Chung-Ho Memorial Hospital; D.L. Saaibi, MD, Medicity S.A.S.; R. Bonin, BS; J. Bukowski, MS, PhD; R. Pedersen, MS; B. Vlahos, MBA, BSN, RN, Director; S. Kotak, MS, MBA, Inflammation and Immunology, Pfizer.
Ron
R
Pedersen
From the Paris Descartes University, Cochin Hospital, Paris, France; Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Medicity S.A.S., Bucaramanga, Colombia; Pfizer, Collegeville, Pennsylvania; Pfizer, New York, New York, USA.M. Dougados, MD, President, Clinical Epidemiology and Biostatistics, Paris Descartes University, Cochin Hospital; W.C. Tsai, MD, Division of Rheumatology, Chung-Ho Memorial Hospital; D.L. Saaibi, MD, Medicity S.A.S.; R. Bonin, BS; J. Bukowski, MS, PhD; R. Pedersen, MS; B. Vlahos, MBA, BSN, RN, Director; S. Kotak, MS, MBA, Inflammation and Immunology, Pfizer.
Bonnie
B
Vlahos
From the Paris Descartes University, Cochin Hospital, Paris, France; Chung-Ho Memorial Hospital, Kaohsiung, Taiwan; Medicity S.A.S., Bucaramanga, Colombia; Pfizer, Collegeville, Pennsylvania; Pfizer, New York, New York, USA.M. Dougados, MD, President, Clinical Epidemiology and Biostatistics, Paris Descartes University, Cochin Hospital; W.C. Tsai, MD, Division of Rheumatology, Chung-Ho Memorial Hospital; D.L. Saaibi, MD, Medicity S.A.S.; R. Bonin, BS; J. Bukowski, MS, PhD; R. Pedersen, MS; B. Vlahos, MBA, BSN, RN, Director; S. Kotak, MS, MBA, Inflammation and Immunology, Pfizer.
Sameer
S
Kotak
D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects / Q000627:therapeutic use; D001208:Asia; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D000068800:Etanercept / Q000009:adverse effects / Q000627:therapeutic use*; D005060:Europe; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D007843:Latin America; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D025241:Spondylarthritis / Q000175:diagnosis* / Q000188:drug therapy* / Q000523:psychology; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D007166:Immunosuppressive Agents; D000068800:Etanercept
ETANERCEPT; NONRADIOGRAPHIC AXIAL SPONDYLOARTHRITIS; QUALITY OF LIFE; SPONDYLOARTHROPATHIES; TUMOR NECROSIS FACTOR-α; WORK