838 Russell with RA.Torrance et al.reported changes in activity (numeric rating scale).patient general o e orms.as a meas treatmen ecei ed Hr-OOl n therapy hac QOL POP ciated with significantly s with lower scores in those HUI attributes that may be ed the HA-DI.com ared with those expected to be reduced as a result of RA:pain, who received either monotherapy.Improvements in dexterity and ambulation.However,other attributes HR-QOL were more rapid and were sustained long er in the combination therapy group than in eithe lation norms monotherapy group (combination vs methotrexate in total HUI3 Crreres.ved with adalimum p=0.005:combi 30.00 exter the duration of the trials.which ained ma e,p as lon nd than with 1 vear.These im ments wer significantly - thotrexate perior to those observed with methotrexate mono In contrast,Farahani et al.conducted a 1-year therapy.While improvements in ambulation were community-based study that compared patients with also noted,this only reachec statistical significance RA who were able to obtain etanercept after its relative to methotrexate in the 1-year study.Higher on into the Canadian market (active treat ment,n=223)with those unable to obtain this agen pumher of OALYs lone.Th ined tients a other the 12-m ate was 0.145 and 0.104 in the two studies.and was cause of improved physical (rather than emotional statistically significant (p<0.001). or mental)parameters,improvements in QOL were documented within the first 6 months in patients who received etanercept compared with those who While is als nti-TN did not.However,this difference between groups ne onsignificant r some QOL e of .es tigue inten y,dur y he and adalimumab.Etanercept is a recombinant obtained in the TEMPO(Trial of Etane cept and Methotrexate with radioo nhic patient outeomes trial of etanercept and methotrexate2 highlight the for red inducing major clinic differences that may often be observed betweer 10 also carry over into economic analyses. Patient-reported outcome 5.4 Anakinro were evaluated in a I-vear randomized double-blind clinical trial of Anakinra is a recombinant interleukin(IL)-1 re- etanercept in combination with methotrexate com- eptor antagonist that is similar to the endogenous pared with either DMARD as monotherapy.Out- IL-1 receptor antagonist (IL-Ira).Like TNFo,IL- s a pro-infla heDe truments such as and th Q-5D visual ana receptor,anaki mmatory response Ahodowaegu ough anakinra h838 Russell with RA, Torrance et al.[61] reported changes in activity (numeric rating scale), patient general health utility using the HUI3, compared with popu- health assessment (visual analogue scale) and pa￾lation norms, as a measure of HR-QOL.[61] Baseline tient satisfaction with treatment.[62] Patients who HUI3 scores were significantly lower (p < 0.001) received combination therapy had significantly im￾than population norms,[61] and this reduction in HR- proved HR-QOL and were more likely to achieve QOL was primarily associated with significantly population norms with regard to function, as indicat￾lower scores in those HUI attributes that may be ed by scores on the HAQ-DI, compared with those expected to be reduced as a result of RA: pain, who received either monotherapy. Improvements in dexterity and ambulation. However, other attributes HR-QOL were more rapid and were sustained long￾also showed significant reductions relative to popu- er in the combination therapy group than in either lation norms.[61] Rapid improvements from baseline monotherapy group (combination vs methotrexate, in total HUI3 scores, as well as in the attributes of p = 0.005; combination vs etanercept, p = 0.002; pain and dexterity, were observed with adalimumab etanercept vs methotrexate, p = 0.780).[62] Patients plus methotrexate treatment and were sustained over also reported significantly greater satisfaction with the duration of the trials, which was as long as combination and etanercept monotherapy than with 1 year. These improvements were significantly su- methotrexate monotherapy.[62] perior to those observed with methotrexate mono- In contrast, Farahani et al.[63] conducted a 1-year therapy.[61] While improvements in ambulation were community-based study that compared patients with also noted, this only reached statistical significance RA who were able to obtain etanercept after its relative to methotrexate in the 1-year study. Higher introduction into the Canadian market (active treat￾proportions of adalimumab-treated patients ment, n = 223) with those unable to obtain this agent achieved or exceeded HUI3 population norms than (control, n = 208). As a reflection of actual clinical patients treated with methotrexate alone.[61] The practice, these patients had no previous treatment number of QALYs gained per year among with etanercept, and no restrictions were placed on adalimumab-treated patients relative to methotrex- other therapies during the 12-month study.[63] Be￾ate was 0.145 and 0.104 in the two studies, and was cause of improved physical (rather than emotional statistically significant (p < 0.001). or mental) parameters, improvements in QOL were documented within the first 6 months in patients 5.3 Etanercept who received etanercept compared with those who While etanercept is also an anti-TNF did not. However, this difference between groups α agent that decreased or became nonsignificant for some QOL binds to TNF and blocks its interaction with cell variables, especially pain severity and fatigue inten- receptors on the cell surface, it is a different type of sity, during the second 6 months.[63] The apparent entity from the monoclonal antibodies infliximab inconsistency between these QOL results and those and adalimumab. Etanercept is a recombinant obtained in the TEMPO (Trial of Etanercept and human fusion protein for the soluble TNFα recep- Methotrexate with radiographic Patient Outcomes) tor.[56] It may be used as monotherapy or in combi- trial of etanercept and methotrexate[62] highlight the nation with methotrexate, and is indicated for reduc- differences that may often be observed between ing signs and symptoms, inducing major clinical clinical trials and clinical practice, and which may response, inhibiting the progression of structural also carry over into economic analyses.[63] damage and improving physical function in patients with moderately to severely active RA.[56] 5.4 Anakinra Patient-reported outcomes were evaluated in a 1-year randomized double-blind clinical trial of Anakinra is a recombinant interleukin (IL)-1 re￾etanercept in combination with methotrexate com- ceptor antagonist that is similar to the endogenous pared with either DMARD as monotherapy. Out- IL-1 receptor antagonist (IL-1ra). Like TNFα, IL-1 comes included standard QOL instruments such as is a pro-inflammatory cytokine, and by blocking its the HAQ-DI and the EQ-5D visual analogue scale, access to the IL-1 receptor, anakinra may downregu￾as well as patient global assessment of RA disease late the inflammatory response. Although anakinra © 2008 Adis Data Information BV. All rights reserved. Pharmacoeconomics 2008; 26 (10)