Ibrutinib (Imbruvica) in combination therapy for people who have not had treatment for CLL
In 2019, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of ibrutinib when used in combination therapy compared to the standard treatment for chronic lymphocytic leukemia (CLL) – more specifically, for people who have not had treatment for CLL before and who are not able to have chemotherapy and immunotherapy.
For this purpose, they analyzed the data from one study involving 145 patients. 73 of the patients were given ibrutinib and obinutuzumab, and 72 of them had the standard treatment of chlorambucil and obinutuzumab. Treatment using obinutuzumab and chlorambucil was limited to a maximum of 6 treatment cycles each.
This is what was found:
What are the advantages of ibrutinib?
Severe side effects: Initial results suggest that ibrutinib and obinutuzumab has an advantage over the standard treatment in women: Women who were given ibrutinib and obinutuzumab experienced severe side effects after nearly 8 months on average (median value). Women who were given chlorambucil and obinutuzumab experienced severe side effects after a little over 1 month on average (median value).
There was no difference here in men: Regardless of which treatment they were given, they had severe side effects after about 3 to 4 months on average (median value).
In addition, the results suggest that the combination of ibrutinib and obinutuzumab has advantages regarding some individual severe side effects in both men and women.
The initial results also suggest that the combination of ibrutinib and obinutuzumab has advantages compared to chlorambucil and obinutuzumab in terms of the following side effects:
- Reaction to the obinutuzumab infusion
What are the disadvantages of ibrutinib?
Heart diseases: Initial results suggest that the combination of ibrutinib and obinutuzumab has a disadvantage here compared to chlorambucil and obinutuzumab.
Life expectancy: There was no real difference between the two treatment groups here. Regardless of which treatment was used, about 19 out of 100 patients passed away in each group.
General health: There was no real difference between the two treatments here. The patients in the study were asked to assess their general health themselves.
Treatment stopped due to side effects: There was no difference here either.
Infections and parasitic diseases: There was no difference between the two treatment groups in terms of this side effect.
Skin conditions: There was no real difference regarding this side effect.
What remains unanswered?
Symptoms of the disease and quality of life: The manufacturer didn’t provide any data on this.
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Ibrutinib (chronic lymphocytic leukemia) – Benefit assessment according to §35a Social Code Book V; Dossier assessment; Commission A19-77. November 28, 2019. (IQWiG reports; Volume 848).
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