RA: Novel Strategies with ‘Old’ Drugs

A wide range of topics related to TNFi's were reported today at EULAR, from a new triple therapy regimen with adalimumab + MTX + steroids, to alternative treatment paradigms, durability of TNFi, and lack of placental transfer of certolizumab pegol.

EULAR guidelines for RA include use of steroids (often as bridging/induction therapy). Roberto Caporali (OP0015) presented the results of an RCT that examined remission and maintenance with high-dose steroids, adalimumb and MTX. The idea was to front-end load active early RA patients with negative prognostic factors by using MTX + ADA + high-dose steroids (tapered off over 6 months) compared to MTX + ADA + placebo (i.e. a new type of triple therapy). In total, 236 patients were randomized. Six months after stopping steroids or placebo, remission rates were not different between the groups, but there was a higher rate of side effects with triple therapy. This study suggests that steroids do not add value, however another comparison could be considered using steroids + MTX vs. ADA + MTX (due to cost differences) or trying this only in MTX inadequate responders.

Turesson et al (OP0016) presented new data from the Swedish (ARTIS) registry on the comparative effectiveness of TNFi's in >5,800 RA patients. Not surprisingly, there were more drop-outs with infliximab and there was higher retention with etanercept and adalimumab. There were no differences for the other TNFi's except that numerically certrolizumab had somewhat more frequent early drop-outs. Effectiveness was lower only for infliximab and all the rest were not significantly different from the reference, etanercept. There may be confounding factors over time where later products may be used and switched more often as other options become available, but the data are consistent with other studies suggesting that infliximab lacks durability.

Xavier Mariette (OP0017) presented a study evaluating placental transfer of certolizumab pegol (CZP, Cimzia) with a specific assay to understand how much CZP is (or is not) transmitted through the placenta. Moms had to be at least 30 weeks pregnant. Most had RA, but some patients had other diseases for which CZP is indicated (e.g. Crohn’s, PsA, etc). There were 14 babies evaluated. All had normal growth and 13 of 14 had no detectable CZP in their blood at the time of delivery; one baby had a very low level of CZP (the mother had the highest CZP blood levels). Similarly, CZP levels in cord blood were very low with only a handful of cases showing very low levels. This is reassuring.

Finally, preliminary results of a Canadian study (disclosure, it was presented by yours truly!) (Pope et al, OP0018) examining DMARD withdrawal in RA patients on CZP were reported. In this Canadian observational study, RA patients who achieved a therapeutic response with CZP combined with a wide range of non-biologic DMARDs were randomized to continuing their regimen or to stopping the DMARD(s). Although there were no differences in outcomes between the two groups, numerically there was a better response at the end of the study in patients who continued DMARD(s) and CZP vs. those who were randomized to discontinue their DMARD(s). We will soon know if we can stop DMARDs in patients who do not tolerate them as a background regimen. More to come as this trial is fully enrolled and the final results are pending.

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