Patients with relapsing-remitting multiple sclerosis (RRMS) who switched to infusions with Sanofi Genzyme’s Lemtrada (alemtuzumab) report increased satisfaction with treatment and improvements in health-related quality of life, according to preliminary data from two ongoing clinical studies.
Those findings were presented May 7 at the 2019 American Academy of Neurology (AAN) Annual Meeting in Philadelphia.
The interim results of two real-world studies surveying patient-reported experiences were detailed in two posters: “Treatment Sequencing and Satisfaction With Alemtuzumab in Relapsing Multiple Sclerosis Patients: Interim Results of the Real-world PRO-ACT Study,” and “Significant and Clinically Meaningful Health-Related Quality of Life Improvements With Alemtuzumab in RRMS Patients in Clinical Practice: Interim Results From a Prospective, Non-Interventional, Real-World Study (PROMiS).“
One poster reports data from the PRO-ACT study, a two-year, observational study, evaluating patient-rated treatment satisfaction among RRMS patients who switched to Lemtrada from a prior disease-modifying treatment (DMT), in routine clinical practice. Up until June 2018, the study enrolled 201 patients in the U.S., Puerto Rico, and Canada.
The primary objective is to address patients’ experiences with Lemtrada, in particular their satisfaction with the treatment, which is assessed through the patient-reported Treatment Satisfaction Questionnaire for Medication (TSQM). That questionnaire includes four domains: global satisfaction, effectiveness, side effects, and convenience, with higher scores indicating greater satisfaction.
This preliminary (interim) analysis assessed changes in TSQM in 83 patients from whom data were available after one year of treatment with Lemtrada.
Most of these patients were transitioning to Lemtrada due to lack of effectiveness, safety, or tolerability of prior DMTs, including Tysabri (natalizumab, by Biogen; 36.8% of the patients), Gilenya (fingolimod, by Novartis; 14.4%), Tecfidera (dimethyl fumarate, by Biogen; 13.4%), Aubagio (teriflunomide, by Sanofi Genzyme; 12.4%), IFNB (11.4%), and Copaxone (glatiramer acetate, by Teva Pharmaceutical; 7.5%).
Results showed that patients reported improvements in global satisfaction, as well as treatment effectiveness, one year after switching to Lemtrada; however, they rated more side effects, and no changes in convenience.
The second poster focused on another ongoing real-world study, called PROMiS, in which the main objective is to determine the impact of Lemtrada in health-related quality of life of people with RRMS in the U.S.
During one year, patients are asked to complete three questionnaires: the Multiple Sclerosis Impact Scale (MSIS)-29, which evaluates health-related quality of life, especially the physical and psychological impact of MS; the Multiple Sclerosis Performance Scale (MSPS); and the Patient-Determined Disease Steps (PDDS). The latter two evaluate MS-associated disability.
Of note, higher MSPS and PDDS scores indicate greater disability in functional health, while higher MSIS-29 scores indicate worse health-related quality of life.
Interim data presented at the AAN meeting included eight-month follow-up results for 171 patients (mean age 44.8 years), most of whom (97.7%) had switched to Lemtrada from a prior MS therapy.
Patients reported clinically meaningful improvements in health-related quality of life, both in their physical and psychological conditions, as well as a numerical — but not clinically significant — increase in their functional ability.
“Patient-reported outcomes are increasingly being used in clinical practice to provide insight into the patient’s perspective of relapsing MS and treatment,” Sibyl Wray, MD, director of the Hope Neurology MS Center in Knoxville, Tennessee, said in a press release.
“The interim results being reported at AAN from the PRO-ACT and PROMiS studies are encouraging, as they show that Lemtrada-treated patients experienced improvements in treatment satisfaction and health-related quality of life,” Wray said.
The next step is to evaluate patient-reported satisfaction and quality of life after the completion of the second course of Lemtrada, which will start 12 months after the first course.