Background/Purpose:

Last years, biological dose tapering in patients with inflammatory diseases has become a routine clinical practice. Since 2011 we are applying a dose reduction protocol in our biological monographic consultation and our day hospital : etanercept dosage from 50 mgrs to 25 mgrs subcutaneous weekly injection, adalimumab 40 mgrs subcutaneous injection administration spacing of 2 to 3 weeks, tocilizumab, dose reduction from 8 mgrs/kg to 6 mgrs/kg. Thus we have achieved optimization rates in our patients close to 40% at the end of 2013.

 The aim of this study is to analyze baseline characteristics and course of the disease in these optimized patients, in order to improve our treatment protocols if possible.

Methods: : Retrospective analysis of data from clinical records and database of 115 patients under therapy with etanercept, adalimumab and tocilizumab, with  at least two year evolution of dose reduction or withdrawal. We consider baseline features, drug, time of dose tapering, including frecuency, time and course of flares if happened. We used SPSS 21.0 for statistical analysis

Results:

115 patients (59 female and 56 male), 34% with rheumatoid arthritis (RA), 62.6% with axial or peripheral spondylitis (SPa), including psoriatic arthritis, and 3.5% juvenile idiopatic arthritis (JIA), most of them with longstanding disease (148.47 months, range 18-638), and long time disease remission at optimization (33.46 months, range 6-134).  26 patients stopped biological treatment, but most of them (22) for other clinical conditions (surgery, infection, poor adherence, adverse events, malignancy).  Optimized patients kept in remission  for 34,24 months (range 10-77).                                     

32.2% of patients flared, 46,2% suffering from RA and 26.4% with SPa, which means statistically significant difference (chi square 4.45, p=0.035). There was no significant difference among biological drugs analized in terms of flare at any indication, or when you considered SPa, but the differences reached significance when you compare flared RA patients under adalimumab (18.8%) and etanercept (46.3%), Chi square: 16.5; p<0,001.

RA patients flared earlier than SPa patients, with statistical significance (Log Rank test p: 0,027), and this was not influenced by concomitant therapy or the use of metotrexate, but by the biological drug used: RA patients under etanercept flared earlier than SPa (difference in survival curve). This  did not occur among patients under adalimumab.

Extraarticular disease (psoriasis, uveitis, diarrhea) was the main manifestation of flare in 42% of our SPa patients.

Conclusion:  In our experience dose reduction of biological therapies is safe and cost effective, even withdrawall is possible in selected cases. Concerning therapy with etanercept, we must consider a most conservative dose reduction protocol, at least in our RA patients. In SPa patients we must pay close attention extraarticular manifestations specially when dose tapering.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/biological-drugs-dose-tapering-in-inflammatory-rheumatic-diseases-2-year-results-at-basurto-university-hospital/