Background It is known from the COMET-trial1 that patients who start Etanercept (ETN) treatment early have a great chance of reaching clinical remission and radiographic non-progression. However, it is still unclear, how many patients with either Rheumatoid Arthritis (RA) or Psoriatic Arthritis (PsA) achieve remission and radiographic non-progression under the conditions of routine rheumatologic care.
Objectives To collect data on radiological progression, disease activity and safety in RA and PsA patients in Germany during long-term routine use of ETN (up to 36 months).
Methods 2000 adult RA and PsA patients with x-rays of hands and feet available at baseline (<3 months prior to or after start of ETN treatment) are recruited in this ongoing non-interventional trial. X-rays of hands and feet taken 52 to 78 weeks after baseline (2nd x-ray) as well as historic x-rays taken 12 to 48 months prior to baseline (if available) are collected. Radiological progression is evaluated with blinded sequence by 2 different raters using the “van der Heijde modified Total Sharp Score”2 (mTSS). Furthermore, the disease course is documented in regular intervals for up to 78 weeks by e.g. disease activity score (DAS28). Finally, another x-rays and data on disease activity and safety will be collected 30 to 36 months after baseline. Here we present the data of the first interim analysis of the trial.
Results So far, 141 patients with RA (and 36 with PsA, not presented here) completed phase 1 of the study and were evaluated for this interim analysis. The mean disease duration (i.e. time from diagnosis to baseline) was 8.3±9.4 yrs. Baseline x-rays of 111 patients could be evaluated (mean mTSS=22.6±32.6). Thereof, 107 patients had x-rays at baseline and after 52 to 78 weeks with a mean radiographic progression of 1.4±6.8 under ETN therapy. 58 patients had a historic and a baseline x-ray with a mean radiographic progression of 4.7±22.1. On ETN treatment, 29.9% of patients experienced no change (-0.5 to 0.5) and 31.8% an improvement (<-0.5) of mTSS. In total, 61.7% were considered to be in radiographic remission. Comparison between the radiographic progression under ETN treatment with prior disease progression (before baseline x-ray) revealed a smaller radiographic progression per year under treatment with ETN (-4.3±23.08; p=0.1.73). The difference is not significant due to the small number of patients in this analysis. DAS28 decreased from a mean baseline value of 4.6±1.3 to 2.9±1.1 at week 78 indicating a lower disease activity under ETN treatment. A total of 41.2% of the patients reached DAS28 remission (DAS28<2.6) at week 78. Treatment with ETN was well tolerated and no new safety signals have been observed.
Conclusions This is the first prospective, non-interventional study evaluating radiographic progression before and during treatment with ETN in individual adult RA and PsA patients. These preliminary results confirm that treatment with ETN lowers radiographic progression, reduces diseases activity and is well tolerated in RA patients over a time frame up to 78 weeks also in routine treatment.
Lancet 2008; 272: 375-382.
J. Rheumatol 2000; 27: 261-63.
Acknowledgements The study was funded by Pfizer Pharma GmbH.
Disclosure of Interest S. Wassenberg Consultant for: AbbVie, Chugai, Janssen, MSD, Novartis, Pfizer, Roche and UCB., Speakers bureau: AbbVie, Chugai, Janssen, MSD, Novartis, Pfizer, Roche and UCB., R. Rau Consultant for: Pfizer Pharma GmbH, T. Klopsch Consultant for: Abbvie, BMS, MSD, Pfizer, Roche, UCB, Speakers bureau: Abbvie, BMS, MSD, Pfizer, Roche, UCB, R. Lippe Shareholder of: Pfizer Inc, Employee of: Pfizer Pharma GmbH, U. Lendl Shareholder of: Pfizer Inc, Employee of: Pfizer Pharma GmbH, P.-A. Löschmann Shareholder of: Pfizer Inc, Employee of: Pfizer Pharma GmbH