Factors related with treatment adherence to interferon b and glatiramer acetate therapy in multiple sclerosis

Abstract

Background: Awareness of the factors influencing discontinuation of immunomodulatory drugs (IMD) treatment in multiple sclerosis (MS) can help to find approaches to patient management with the aim of establishing more specific indications and also attaining more optimal patient selection in future clinical trials. Objective: To identify the causes that influence adhesion to IMD therapy within the clinical practice in a large cohort of patients with MS. Patients and methods: We have studied all MS patients who have initiated IMD in our hospital. All patients took part in training sessions where treatment expectations and side effects were explained and they received training in the administration technique. Reasons for stopping therapy were recorded during follow-up. Results: We studied 632 MS patients (mean follow-up was 47.1 (28.7) months). At the time of analysis, 107/632 patients (17%) were no longer receiving IMD. Almost half of the patients who stopped IMD (52/107) did so within the first two years on therapy. Fifty-six patients stopped IMD because of lack of efficacy. Only 27 patients (4.3%) discontinued treatment for reasons other than inefficacy or side effects. The proportion of patients with secondary progressive MS that stopped IMD therapy was 30%, while only 13.5% of the patients with relapsing—remitting MS stopped therapy (P= 0.0001). Expanded Disability Status Scale (EDSS) score at entry was the main factor that predicted interruption of therapy. Conclusions: The proportion of patients interrupting IMD in our centre is low, possibly due to individualized care. Higher EDSS, mainly in the first two years of treatment, is the main factor related with interruption. Close follow-up of these patients would be useful in avoiding early discontinuation of therapy.

Keywords

interferon multiple sclerosis immunomodulatory adherence response efficacy

Get full access to this article

View all access options for this article.

References

The IFNβ Multiple Sclerosis Study Group . Interferon beta-1b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial . Neurology 1993; 43: 655-661 .

Jacobs LD , Cookfair DL , Rudick RA , Herndon RM , Richert JR , Salazar AM et al. Intramuscular interferon b-1a for disease progression in relapsing multiple sclerosis . Ann Neurol 1996; 39: 285-294 .

PRIMS Study Group . Randomised double-blind placebo-controlled study of interferon b-1a in relapsing-remitting multiple sclerosis . Lancet 1998; 352: 1498-1504 .

Johnson KP , Brooks BR , Cohen JA , Ford CC , Goldstein J , Lisak RP et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: results of a phase III multicenter, double-blind placebo-controlled trial. The Copolymer 1 Multiple Sclerosis Study Group . Neurology 1995; 45: 1268-1276 .

Tremlett HL , Oger J. Interrupted therapy. Stopping and switching of the b-interferons prescribed for MS . Neurology 2003; 61: 551-554 .

Taus C , Taffi R , Morelli M , Fie A , Angeleri VA , Sgolastra M et al. Adherence to IFNβ therapy in multiple sclerosis: an Italian clinical setting . Mult Scler 2001; 7: S55-S55 .

Mohr DC , Goodkin DE , Likosky W , Gatto N , Neilley LK , Griffin C et al. Therapeutic expectations of patients with multiple sclerosis upon initiating interferon beta 1b: relationships to adherence to treatment . Mult Scler 1996; 2: 222-226 .

Mohr DC , Goodkin DE , Masuoka L , Dick LP , Russo D , Eckhardt J et al. Treatment adherence and patient retention in the first year of a Phase III clinical trial for the treatment of multiple sclerosis . Mult Scler 1999; 5: 192-197 .

Goodin DS , Frohman EM , Garmany GP , Halper J , Likosky WH , Lublin FD et al. Disease modifying therapies in multiple sclerosis . Neurology 2002; 58: 169-178 .

10.

Neilley L , Goodin DS , Goodkin DE , Hauser SL. Side effect profile of interferon beta-1b in MS: Results of an open label trial . Neurology 1996; 46: 552-554 .

11.

Weinshenker BG , Issa M , Baskerville J. Long-term and short-term outcome of multiple sclerosis. A 3-year follow-up study . Arch Neurol 1996; 53: 353-358 .

12.

Rio J , Nos C , Tintore M , Borras C , Galan I , Comabella M et al. Assessment of different treatment failure criteria in a cohort of relapsing-remitting MS patients treated with interferon beta. Implications for clinical trials . Ann Neurol 2002; 52: 400-406 .

13.

Milanese C , La Mantia L , Palumbo R , Martinelli V , Murialdo A , Zaffaroni M et al. A post-marketing study on interferon beta-1b and 1 a treatment in relapsing-remitting multiple sclerosis: different response in drop-outs and treated patients . J Neurol Neurosurg Psychiatry 2003; 74: 1689-1692 .