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Long-Term Efficacy And Safety Profile Of The Anti-TNF Golimumab Confirmed

MSD have announced that five-year data from pivotal Phase 3 clinical studies demonstrate that once-monthly, subcutaneous (SC) injections of Simponi® () provided sustained improvements in the signs and symptoms of patients with both active ankylosing spondylitis (AS) and moderate to severe, active rheumatoid arthritis (RA) over five years.1, 2 The new findings from long-term extensions of the GO-FORWARD and GO-RAISE clinical studies were presented at the 2013 European League Against Rheumatism (EULAR) Annual Congress.

Professor Peter Taylor, Norman Collison Professor of Musculoskeletal Sciences, Kennedy Institute of Rheumatology, Oxford said: ‘These five-year data provide us with important clinical evidence of how patients with debilitating diseases such as rheumatoid arthritis and ankylosing spondylitis respond over the long-term to golimumab, and also confirms that the safety profile of the therapy is consistent with previous results and with other anti-TNFs.’

Additionally, new published data3 from the observational GO-MORE study, also presented at EULAR4, showed improved efficacy and comprehensive disease control when once-monthly, subcutaneous (SC) injections of golimumab 50 mg were added to conventional disease-modifying anti-rheumatic drug (DMARD) therapy in with active RA for a period of six months, as measured by clinical indices and patient reported outcomes.4 More than 3,000 RA patients were enrolled in the open-label, multi-national, prospective study.4

Ruth Slack, Rheumatology Nurse, West Suffolk NHS Trust said: ‘These findings are most reassuring – improving physical function is an important outcome for patients and achieving sustained, long-term reduction in symptoms of progressive rheumatological diseases is the desired goal of an effective therapy.’

GO-RAISE

The findings from the GO-RAISE (GOlimumab – A Randomized Study in Ankylosing Spondylitis Subjects of a Novel Anti-TNF mAB Injection (SC) Given Every Four Weeks) study demonstrated that reductions in AS signs and symptoms, and improvements in physical function and range of motion, among patients receiving golimumab 50 mg or golimumab 100mg for active AS were sustained through five years.1 In the randomized, placebo-controlled Phase 3 study of 356 patients with active AS, patients were randomized to placebo, golimumab 50 mg or golimumab 100 mg; those randomized to placebo were switched to golimumab 50 mg at Week 16 or Week 24.1 Of the 356 patients originally randomized, 254 were evaluated at five years; reductions in AS signs and symptoms and improvements in physical function and range of motion were sustained through five years.1

As determined by improvements according to the Assessment in SpondyloArthritis International Society criteria (ASAS), 43 percent of patients in the placebo group who were switched to golimumab at Week 16 or Week 24 achieved partial remission (24 of 61); 51 percent (48 of 94) of patients receiving golimumab 50 mg and 39 percent (38 of 98) of patients receiving golimumab 100 mg achieved partial remission.1 Golimumab 50 mg and golimumab 100 mg also demonstrated an acceptable safety profile consistent with prior study results and with other anti-TNF therapies; there were no observed differences between the two treatment arms.1

GO-FORWARD

The findings from the GO-FORWARD (GOlimumab FOR Subjects With Active RA Despite Methotrexate) study demonstrated that reductions in signs and symptoms and , and improvements in physical function, among patients receiving golimumab 50 mg and methotrexate for the treatment of moderate to severe, active RA were sustained through five years.2 In the randomized, placebo-controlled Phase 3 study, of the 444 patients with active RA initially randomized, 313 continued treatment through to week 252. Patients were randomized to receive placebo and methotrexate, golimumab 100 mg and placebo, golimumab 50 mg and methotrexate or golimumab 100 mg and methotrexate.2 Patients receiving placebo and methotrexate crossed over to receive golimumab and methotrexate at weeks 16 or 24.2

At the end of the treatment period (week 256), 77 percent of patients (57 of 74) randomized to receive golimumab 50 mg in combination with methotrexate achieved at least a 20 percent improvement in American College of Rheumatology criteria (ACR 20), and 54 percent (40 of 74) of patients randomized to receive golimumab 50 mg with methotrexate achieved at least a 50 percent improvement (ACR 50).2 The study also evaluated patients’ disease activity and physical function at five years, as measured by EULAR response and HAQ-DI score improvement of at least 0.25; these criteria were achieved in 89 percent (65 of 73) and 74 percent (55 of 74) of patients randomized to receive golimumab 50 mg with methotrexate, respectively. 2

Radiographic progression appeared controlled in patients randomized to receive golimumab and methotrexate in the GO-FORWARD study, with 59 percent (47 of 79) of patients randomized to receive golimumab 50 mg and methotrexate demonstrating no radiographic progression at week 256, defined as a change from baseline in the vdH-S score of < 0. 2

GO-MORE

The findings from the GO-MORE study demonstrated that six months of add-on treatment with golimumab 50 mg resulted in good comprehensive disease control in patients in adult patients with active RA, whose disease had progressed despite treatment with DMARDs and who were naïve to biologic therapy.4 At baseline, 21 percent of patients were diagnosed with moderate disease activity (DAS28-ESR EULAR 3.2 to 5.1) while 79 percent had high disease activity (DAS28-ESR EULAR >5.1).4 At Month 6, remission based on DAS28-ESR and simplified disease activity index (SDAI) was attained by 24 percent and 14 percent of patients, respectively.4 Low disease activity based on DAS28-ESR and SDAI was reached by 38 percent and 48 percent of patients at Month 6, respectively.4 Patients with moderate baseline disease activity were more likely to achieve remission (DAS28-ESR = 43 percent; SDAI = 24 percent) or low disease activity state (DAS28-ESR = 63 percent; SDAI = 64 percent) than those with high baseline disease activity (DAS28-ESR = 19 percent (p<0.0001); SDAI = 12 percent / DAS28-ESR = 31 percent (p<0.0001); SDAI = 44 percent (p<0.0001), respectively).4 Also at Month 6, patient acceptable symptom state (PASS) and minimal or no functional impairment (HAQ-DI ≤0.5) were achieved by 66 percent and 37 percent of patients, respectively.4

Source

1. Deodhar, A., Braun, J., Inman, R., et al. Long-term safety and efficacy of golimumab in the treatment of ankylosing spondylitis: results through 5 years of the GO-RAISE trial. Poster presented at EULAR June 2013.

2. Keystone, E., Genovese, MC., Hall, S., et al. Five-year safety and efficacy of golimumab in patients with active rheumatoid arthritis despite prior treatment with methotrexate: final study results of the phase 3, randomized placebo-controlled GO-FORWARD trial. Abstract presented at EULAR June 2013.

3. Combe, B., Dasgupta, B. Louw, I ., et al Efficacy and safety of golimumab as add-on therapy to disease-modifying antirheumatic drugs: results of the GO-MORE study. Published online 5 June 2013.

4. Combe, B., Veale, D., Burgos-Vargas, R., et al. Comprehensive disease control with golimumab in patients with rheumatoid arthritis. Abstract presented at EULAR June 2013.

Please refer to the Summary of Product Characteristics for full information on ‘Simponi’ including contraindications, precautions, special warnings and side effect information. Available here.

European League Against Rheumatism (EULAR)