Highlights from the WCO-IOF-ESCOE osteoporosis conference in Krakow, Poland.

Last week I attended the annual WCO-IOF-ESCOE osteoporosis conference, which was held at the ICE Congress Centre in the beautiful city of Krakow, Poland. What were the major themes and stand-out talks during the four days? Here are my picks.

Osteoporosis diagnosis

One of the major obstacles in osteoporosis is the large treatment gap; too few patients that could greatly benefit from osteoporosis therapies are currently not receiving them. Two of the major initiatives that were discussed throughout the congress were the use of fracture risk assessment (FRAX) to identify patients, and the success of fracture liaison services (FLS). Use of both has continued to grow strongly year-on-year, and evidence was presented showing their benefits. Results from the SCOOP study showed the feasibility of using FRAX to screen for patients, and then stratify their risk of developing osteoporosis. The FRAX tool has evolved since it was developed, adding additional risk factors, such as glucocorticoid use, and there was a lot of discussion on where FRAX could be improved further. It seems likely that further changes will be made in the future, with one of the most likely additions being the risk of falls added into the calculation. The success of FLS services was frequently presented – they have been shown to be clinically and cost-effective – so the International Osteoporosis Foundation (IOF) are keen increase their use through their “Capture the Fracture” programme. FLSs have been particularly popular in many European countries, but the more fragmented healthcare system in the United States has somewhat constrained their uptake. Currently it’s not clear how this situation may change.

Osteoporosis treatment

The risk of re-fracturing was discussed in several talks. Although FRAX can calculate the 10-year probability of a patient sustaining a re-fracture, that probability is not evenly distributed throughout the ten years, but concentrated in the first two years after fracture. Therefore, there is a high need to treat these patients quickly. There was enthusiasm for concentrating efforts to treat these high-risk patients. However, owing to high patient fear of osteoporosis drug side-effects there is strong reluctance to receive treatment. So, how best to convey to patients the severity of osteoporosis and the importance of disease management? Several strategies were discussed to help patients better understand their osteoporosis risk, including presenting individualised risk estimates more visually (using 3D models, animations, icon arrays, etc). It is hoped that patients who are more enfranchised in their treatment will be more willing to be prescribed drug-treatments, and to be more adherent. Drug adherence is another major obstacle for osteoporosis treatments!

Osteoporosis therapies

As expected, no unpublished data were presented from any new major clinical trials for osteoporosis drugs. However, several talks were dedicated to proving the cost-effectiveness, efficacy, and safety of some of the drugs currently available.

  • Eli Lilly’s Forteo (teriparatide) – Data were provided from the VERO study, which is the first to compare two osteoporosis therapies (Forteo and risedronate), with fracture as the primary end-point. Forteo’s superiority in reducing the risk of vertebral fractures versus risedronate was demonstrated in this study. In further sub-analysis, no heterogeneity in treatment effect was observed across a range of clinically relevant subgroups. Real-world data (RWD) were also presented for Forteo, showing significant reductions in vertebral fractures occur in practice, and not just a clinical trial setting. Although Radius Health’s Tymlos performed favorably head-to-head with Forteo in the ACTIVE trial, Eli Lilly will surely look to capitalize on these strong RWD findings.
  • Amgen’s Prolia (denosumab) – Patient fear of osteonecrosis of the jaw (ONJ) has resulted in a large reduction in treatment rates. Trial data were presented showing the rarity of ONJ events in Prolia-treated patients (0.06 per 100 subject years), and gave clues to which of these patients are most at risk, with most cases observed after an invasive dental procedure. Reassuringly, in the few patients that ONJ was identified, most cases healed with appropriate dental therapy after 4-20 months. Amgen, will be hoping these data will help frame ONJ risks to reassure patients, physicians, and maybe even dentists. RWD analysis was also presented to evaluate patients in ‘real-life’ settings. Prolia was shown to be very effective in reducing the incidence of total, hip, and vertebral fractures in these patients.
  • Radius Health’s Tymlos (abaloparatide) – With little clinical data to assess Tymlos’s efficacy against more established osteoporosis therapies, a network meta-analysis was presented to assess the relative efficacy of Tymlos against alternative drug options, and the probability of each analysed therapy being the most effective treatment. The presenters found Tymlos to be superior to all other osteoporosis therapies in the reduction of vertebral, non-vertebral, and wrist fractures in post-menopausal women. A cost-effectiveness analysis was presented in a separate talk. The authors found that in high-risk patients, Tymlos is cost-effective compared to Prolia and alendronate. However, compared to Forteo, Tymlos was the dominant strategy (both less costly and results in better health outcomes) in all scenarios. Radius Health will undoubtedly be using these findings, and similar analyses, to convince payers, physicians, and patients of Tymlos’ value and effectiveness.

There were many other insightful talks and posters presented, too numerous to talk about here, as well as many thoroughly well-deserved awards that were handed out. I’m sure the organizers of next year’s conference in Paris will be looking to emulate the success of this year’s conference.

 

Key ESMO Highlights 2020

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