Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trialBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c147 (Published 03 February 2010) Cite this as: BMJ 2010;340:c147
- Wolfram Sterry, department chair1,
- Jean-Paul Ortonne, department chair2,
- Bruce Kirkham, lead clinician3,
- Olivier Brocq, rheumatologist4,
- Deborah Robertson, clinical program leader5,
- Ronald D Pedersen, biostatistician5,
- Joanne Estojak, clinical scientist5,
- Charles T Molta, senior medical director, department of inflammation5,
- Bruce Freundlich, multiple therapeutic area head5
- 1Department of Dermatology and Allergy, Charité University Medicine 10117, Berlin, Germany
- 2Department of Dermatology, Hôpital de l’Archet, Nice, France
- 3Rheumatology Department, Guy’s and St Thomas’ NHS Foundation Trust, NIHR Biomedical Research Centre at GStT, London
- 4Princesse Grace Hospital, Monaco
- 5Pfizer Inc, Collegeville, PA, USA
- Correspondence to: W Sterry
- Accepted 16 November 2009
Objectives To compare the efficacy over 12 weeks of two different etanercept regimens in treating the skin manifestations of psoriasis in patients who also have psoriatic arthritis and to evaluate efficacy and safety over an additional 12 weeks of open label etanercept treatment.
Design Randomised double blind multicentre outpatient study.
Setting 98 outpatient facilities in Europe, Latin America, and the Asia Pacific region.
Participants 752 patients with both psoriasis (evaluated by dermatologists) and psoriatic arthritis (evaluated by rheumatologists).
Interventions During the blinded portion of the study, participants were randomised to receive etanercept 50 mg twice weekly (n=379) or 50 mg once weekly (n=373) for 12 weeks by subcutaneous injection. All participants then received open label etanercept 50 mg once weekly for 12 additional weeks, while remaining blinded to the regimen.
Main outcome measures The primary efficacy end point was the proportion of participants achieving “clear” or “almost clear” on the physician’s global assessment of psoriasis at week 12. Secondary efficacy analyses included psoriasis area and severity index, American College of Rheumatology responses, psoriatic arthritis response criteria, and improvement in joint and tendon disease manifestations.
Results At week 12, 46% (176/379) of participants receiving etanercept 50 mg twice weekly achieved a physician’s global assessment of psoriasis of “clear” or “almost clear” compared with 32% (119/373) in the group treated with 50 mg once weekly (P<0.001). In contrast, an equally high percentage of participants in both groups achieved psoriatic arthritis response criteria (77% (284/371) in the twice weekly/once weekly group versus 76% (282/371) in the once weekly/once weekly group). Participants treated with 50 mg twice weekly/once weekly had greater mean reductions from baseline in the psoriasis area and severity index at week 12 compared with those who received 50 mg once weekly/once weekly (71% v 62%, P<0.001), with less difference at week 24 (78% v 74%, P<0.110). Joint and tendon disease manifestations improved from baseline in both groups to a similar extent. No new safety signals were seen in either etanercept treatment group, and no significant difference in the safety profiles was observed.
Conclusions In participants with active psoriasis and psoriatic arthritis, initial treatment of the psoriasis with etanercept 50 mg twice weekly may allow for more rapid clearance of skin lesions than with 50 mg once weekly. A regimen of 50 mg once weekly seems to be appropriate for treatment of joint and tendon rheumatic symptoms. The choice of regimen should be determined by the clinical needs of the individual patient.
Trial registration Clinical trials NCT00245960.
We thank Xuesong Zhang for assistance with statistical content, Robyn Boyle and Precise Publications for manuscript preparation, and Joanne Foehl for assistance with preparation and review of the manuscript. We also to thank the other investigators and their staff who participated in the PRESTA (study 401) study, including: A Gonda and S Szanto, Hungary; S Karpati and E Koo, Hungary; N Aste and A Mathieu, Italy; P Calzavara-Pinton and F Franceschini, Italy; G Trevisan and P Morassi, Italy; G Altomare and F Capsoni, Italy; G Girolomoni and L M Bambara, Italy; M Goitre and R Carignola, Italy; S Calvieri and G Valesini, Italy; P Lisi and R Gerli, Italy; A Katsambas and D Goules, Greece; O Mourelou and I Chatzigiannis, Greece; N Atakan and A I Ertenli, Turkey; S Philipp, Germany; J Prinz and S Schewe, Germany; K Reich and A S Everding, Germany; T Bieber and M Seidel, Germany; M Sebastian and C Holzheimer-Stock, Germany; J Norgauer and T Eidner, Germany; K G Meyer and U Reuter, Germany; G Schuler, M Sticherling (current principal investigator) and M Ronnenberg, Germany; M Schön and C Kneitz, Germany; R Kaufmann and F Behrens, Germany; J Elsner and V Waltz, Germany; T Rosenbach and W Hungerbach, Germany; C L M. Van Hees and C Bijkerk, Netherlands; P C M van de Kerkhof and M Creemers, Netherlands; P M Steijlen and R Landewe, Netherlands; E P Prens and M V van Krugten, Netherlands; M de la Brassinne and M Malaise, Belgium; J Deweert and F van de Bosch, Belgium; W Placek and N Szalwinska-Dolata, Poland; A Langner and E Wiesik-Szewczyk, Poland; M Bagot and P Claudepierre, France; J M Bonnet Blanc and P Bertin, France; L Dubertret and F Lioté, France; G Guillet and I Azais, France; P Joly and O Vittecoq, France; G Lorette and D Mulleman, France; L Misery and A Saraux, France; J F Nicolas and J P Larbre, France; A Taieb and C Gracia, France; P Celerier and E Dernis, France; M Vuillamie and G Guaydier-Souquieres, France; R Gniadecki and K Asmussen, Denmark; G Jemec and M Sonne, Denmark; L Skov and H Slott Jensen, Germany; K E Andersen and L Ejstrup, Denmark; G Larsen and D Vendelbo, Denmark; L Paimela and M Soini, Finland; S Saari and A Similä, Finland; U Lindqvist, Sweden; G M Alenius, Sweden; S Transö, Sweden; P Foley and L Clemens, Australia; J Sullivan and P McNeil, Australia; T F Tsai and S C Hsieh, Taiwan; J C Ho and Y C Chen, Taiwan; J M Vozmediano and J Bernal, Spain; L Puig and C Diaz, Spain; M Garate and E Brito, Spain; L Borrego and A Rosas, Spain; R Vallverdu and J Maymo, Spain; J Zubizarreta Sr and J Belzunegui, Spain; M Gallego and M Crespo, Spain; M Selores, M Brandão, A Marinho and C Vasconcelos, Portugal; A Figueiredo and M J Salvador, Portugal; K Rappersberger and J Hitzelhammer, Austria; H Kerl, B Yazdani, and T Mueller, Austria; J I Youn and Y W Song, Korea; J H Choi and B Yoo, Korea; R M Trueb and D Kyburz, Switzerland; A K L So, Switzerland; E Hamada and S Al-Saleh, Saudi Arabia; A Alajlan and A R Al-Arfaj, Saudi Arabia; R Galimberti, L Cattogio, and J de la Rosa, Argentina; E Chouela, L Messina, and N Villa, Argentina; C Ramos-Remus and F J Aceves Avila, Mexico; J Barker, UK; M Rustin and H L Beynon, UK; J Berth-Jones and R Neame, UK; C Griffiths and R Benitha, UK; A Layton and B Neville, UK; T Tuomiranta and O M Kekki, Finland; A Finlay and S Smale, UK; A Ormerod and N Basu, UK; B Didona and C R Girardelli, Italy; M Majdan, M Piotrowski, B Kolarz, Z Kielbik, M Dryslewska, and J Arsznal, Poland; W Tlustochowicz, M Sulek, M Tlustochowicz, J Rojek, K Ludwiniak, and Z Samochodzki, Poland; L Kemény and G Sonkodi, Hungary; E Szepes and G Horvath, Hungary; N Bakos and T Arok, Hungary; Z Karolyi and K Fazekas, Hungary; N Damjanov, Serbia; A Dimic, Serbia; K Cobeljic, Serbia; B Bobic, Serbia; M Simon and R Haux, Germany; E Dokoupilova, Czech Republic; J Stolfa and L Šedova, Czech Republic; P Vitek, Czech Republic; H N Cabrera and H Leczycki, Argentina; C F Gatti and A Capuccio, Argentina; F Stengel and C Perandones, Argentina; R Burgos Vargas and G Huerta Sil, Mexico; R Alten and E Toppe, Germany; J Wollenhaupt and P Buck, Germany; R T Lehmann and T Hoffmann, Germany; M Fimiani and M Galeazzi, Italy; S Di Nuzzo and D Santilli, Italy; V Descamps and P Dieudé, France; H Castellanos and J F Restrepo, Colombia; E Melendez and E Forero, Colombia; M Richter, Germany.
Contributors: WS, J-PO, BK, and OB recruited and enrolled participants, collected data, and drafted the report. DR and JE designed the trial, wrote protocols for the participating institutions, interpreted the data, and drafted the report. RDP designed the trial, analysed the data, and drafted the report. CM interpreted the data, served as medical monitor during the trial, and drafted the report. All authors edited the final version of the manuscript. WS is the guarantor.
Funding: Wyeth Research, which was acquired by Pfizer in October 2009, sponsored this clinical trial and was responsible for the collection and analysis of data. The authors and the sponsor were involved in the study design, interpretation of data, manuscript preparation, and decision to publish. All statistical analyses were done by the Global Biostatistics and Programming Department of Wyeth Research.
Competing interests: WS has received fees for speaking/consulting from Abbott, Schering-Plough, Wyeth, and Janssen-Cilag. J-PO has received fees for speaking/conferences/consulting from Schering-Plough, Abbott, Merck-Serono, Centocor, Wyeth, Janssen-Cilag, MedPharma, Laboratorios Pierre-Fabre, Galderma Laboratories, and Leo Pharma. BK has served on advisory boards for Schering-Plough and Roche; has received funds for research/travel/conferences from Wyeth, Centocor, Abbott, Schering-Plough, Roche, and Bristol-Myers Squibb; and has served on a speaker panel for Bristol-Myers Squibb. OB has received fees from Wyeth, Schering-Plough, Abbott, Roche, Chugai, and Bristol-Myers Squibb. DR, RDP, JE, CM, and BF are all employees of Pfizer.
Ethical approval: The protocol and its amendments received independent ethics committee or institutional review board approval and regulatory review and approval before site initiation and recruitment of patients. All participants signed and dated an approved informed consent form.
Data sharing: None.
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