PDSA e-News: September 30, 2019

Doctor and patient in research studyPrognostic factors for Immune Thrombocytopenia remission after laparoscopic splenectomy

This retrospective study examined 165 ITP patients who had undergone laparoscopic splenectomy (LS) in order to explore long term effects and factors that predict patient outcomes following surgery. This study found that 70%-90% of patients who received a laparoscopic splenectomy achieved short-term total remission with elevated platelet counts. Of those patients, 66% were able to obtain a long-term total remission after splenectomy. Of note, most relapses from splenectomy will occur within the first two years following surgery.

Significant factors correlating with long-term total remission rates in patients included younger age, higher body mass index (BMI), and a higher platelet count. Patients in this study who were under the age of 41, had a BMI under 24.3, or a preoperative platelet count greater than or equal to 97,000 had a greater chance at long-term ITP remission after splenectomy. The duration of time living with ITP and order of of ITP treatments given did not reveal any relation to the chances of remission post-splenectomy.

Comment from PDSA medical advisors:

Unique findings in this article are:

  1. Defining worse outcomes of splenectomy after age 50. Previous studies had shown that older patients had worse outcomes but had not well-defined an age. To be fair other studies had suggested ages starting at age 45 and varying by study.
  2. The figure shows long-term relapses out to 8 or more years after splenectomy. This has been quite unusual and remains to be better explored.
  3. The findings with BMI (body size including height and weight) are of interest and not surprising since there have been considerable studies suggesting that being overweight is linked to inflammation as well as many other adverse events. As with many studies, it reports findings for groups but does not help individual patients.

The main limitations are that this is a study of retrospective outcomes. It is very hard to be sure what the associations or predictions mean. It is also not clear that this fully reflects all the long- term issues connected with splenectomy ie infections and strokes (as an example of too much clotting).



Research studyComparison of first-line treatments for newly diagnosed Immune Thrombocytopenia

Corticosteroids, prednisolone and dexamethasone are currently the first-therapy options for the treatment of newly diagnosed Immune Thrombocytopenia (ITP). Recent studies have shown that other treatments such as rituximab (Rituxan) or thrombopoietin receptor agonists (eltrombopag (Promacta/ Revolade; romiplostim (Nplate)) can also be effective first-line therapy options. This study established a clinically meaningful hierarchy of treatments for newly diagnosed primary ITP in adults.

Utilizing a total of 21 randomized control trials reviewing1,898 patients in total, the study found that patients achieved a better sustained response from combining ITP treatments, such as recombinant human thrombopoietin (rhTPO) and dexamethasone, or rituximab and dexamethasone, than from the conventional approach of treatment with one first-line therapy at a time, like the use of prednisolone or dexamethasone. In addition, recombinant human thrombopoietin and a steroid option together wasfound to improve early overall response compared to prednisolone, dexamethasone, or rituximab alone. Combination therapy did not display any additional therapy-related adverse effects compared to treatment with a steroid alone; furthermore patients found the drug side effects still tolerable. Therefore, it may be beneficial to consider combination therapy up-front when treating a newly-diagnosed ITP patient. More studies are required to determine the best course of action for patients receiving combination therapy as first-line treatment.

Comment from PDSA medical advisors:

This is a very complicated study that is hard to carefully understand. Key points were made in the limitations section that helped to fully appreciate why the findings were what they were. First, to be “in remission” only required a count off treatment of 30,000/uL. This might be more than adequate but does not speak well to long-term stable responses automatically because a very slight deterioration would indicate a relapse. Using a higher count, at least 50,000/uL off treatment for a number of months, would be much more important and clinically significant.

Second, they only use for long-term outcome 3-6 months. This is just inadequately short to be called long-term outcome. Much better and much more clinically important would be 1 year, 2 years and 3 years and 5 years. As it is the “effects” of TPO agents may well be overweighted because the timeframe is so short. It if were longer, then probably dexamethasone and rituximab would be higher rated.



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