Teriflunomide Improves Patient Satisfaction in Teri-PRO, TENERE Trials

April 26, 2018

The disease-modifying therapy showed significant improvements in 4 TSQM measures for patients with relapsing multiple sclerosis.

Patricia K. Coyle, MD

Teriflunomide (Aubagio, Sanofi Genzyme) has proved to result in treatment satisfaction improvements in patients with relapsing multiple sclerosis (MS), according to dual trial data.

Presented at the American Academy of Neurology’s 70th Annual Meeting in Los Angeles, California, the results of the phase IV Teri-PRO study and phase III TENERE extension trial revealed positive improvements in Treatment Satisfaction Questionnaire for Medication (TSQM) scores. The assessment consists of a 14-part measurement of global satisfaction, efficacy, adverse events (AEs), and convenience of the therapy in question.

In total, 344 patients from both studies were included in the analysis, 285 from Teri-PRO and 59 from TENERE. The patients in Teri-PRO reported significant improvements in all 4 TSQM categories from baseline through the 48-week study period (P <.0001 for effectiveness). In TENERE, significant score improvements were seen in AEs and convenience from baseline through week 48 (P <.0001).

While the improvements were only significant in 2 categories in TENERE, that significance continued through week 96, at which point patient global satisfaction had improved significantly from baseline.

Patricia K. Coyle, MD, director of the Multiple Sclerosis Comprehensive Care Center, Stony Brook University, told NeurologyLive’s sister publication, MD Mag, that patient satisfaction with treatment is a very important aspect of how a patient is doing while on a given therapy.

“With multiple options, you do not want a patient suffering,” Coyle said. “It can have great efficacy, but if a patient’s report is that they’re unhappy with the treatment, I believe that’s a valid reason to switch.”

“The good news in this study is that, pretty uniformly, we saw excellent reported satisfaction with the drugs,” she added.

Patients in Teri-PRO reported the most common AEs to be thinning of hair, diarrhea, nausea, headache, urinary tract infection, alanine aminotransferase increase, nasopharyngitis, and fatigue, while patients in TENERE reported diarrhea, nasopharyngitis, hair thinning, paresthesia, and back pain. Serious AEs from Teri-PRO included MS relapse, hypertension, ALT increase, and urinary tract infection.

In Teri-PRO, 786 of 1000 patients with relapsing MS from 14 real-world global sites completed the treatment period.1 They were switched from either interferon beta-1a or interferon beta-1b to teriflunomide 14 mg for 48 weeks. At baseline, the mean TSQM score for global satisfaction was 53.4, for effectiveness was 58.4, for AEs was 65.2, and for convenience was 58.4. By week 4, those who switched to teriflunomide showed those scores improved to 74.9, 70.2, 89.3, and 93.0, respectively (P <.0001 for all). By week 48, the scores dipped slightly, but remained significant across the board at 69.7 for global satisfaction, 68.5 for effectiveness, 84.8 for AEs, and 90.4 for convenience (P <.0001 for all).

In TENERE, 324 patients with relapsing MS were randomized 1:1:1 to either teriflunomide 7-mg (n = 109) or 14-mg (n = 111) doses, or subcutaneous interferon beta-1a 44 µg (n = 104).2 The baseline scores were not recorded. At week 48, the scores for the 7-mg and 14-mg doses were 68.29 and 68.82 (mean difference from interferon beta-1a, 7.32 and 7.84; P <.02 for both) for global satisfaction, 67.25 and 63.13 (mean difference, 7.95 and 3.84; P <.02 for 7 mg; P <.28 for 14 mg) for effectiveness, 95.29 and 93.15 (mean difference, 23.92 and 21.77; P <.0001 for both) for AEs, and 88.30 and 89.85 (mean difference, 26.40 and 27.96; P <.0001 for both) for convenience, respectively.

Teriflunomide is currently approved in 70-plus countries, with the support of trial data including more than 5000 patients, allowing the research community to add to its resume that demographically-differing patients with relapsing MS reported similar benefits when transferring to the therapy.

REFERENCES

1. Coyle PK, Khatri B, Edwards KR, et. al. Patient-reported outcomes in relapsing forms of MS: Real-world, global treatment experience with teriflunomide from the Teri-PRO study. Mult Scler Relat Dis. 2017;7(17):107-115.

doi

: 10.1016/j.msard.2017.07.006.

2. Vermersch P, Czlonkowska A, Grimaldi LM, et. al. Teriflunomide versus subcutaneous interferon beta-1a in patients with relapsing multiple sclerosis: a

randomised

, controlled phase 3 trial. Mult Scler J. 2013;20(6):705-716.

doi

: 10.1177/1352458513507821.