The addition of chemotherapy with fluorouracil and cisplatin to treatment with external-beam and intracavitary radiation significantly improved survival among women with locally advanced cervical cancer.

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and anti-TNF-experienced 4 patients with RA when administered monthly via subcutaneous injection.Intravenous administration of golimumab every 12 weeks (q12 weeks) was previously assessed in a phase 3 trial in patients with RA, with persistent disease despite MTX therapy. 5 While the study's primary endpoint (≥50% improvement in American College of Rheumatology (ACR50) response criteria at week 14) was not achieved (21.4% vs 13.2%, p=0.051), intravenous golimumab+MTX substantially reduced RA signs/symptoms and improved physical function, particularly beyond week 14. Moreover, intravenous golimumab 2 mg/kg at weeks 0 and 12, plus MTX, yielded a substantially higher ACR20 response at week 14 (55%, 71/129 patients) than placebo+MTX (28%, 36/129); no unexpected toxicities were observed. 5 The current GO-FURTHER trial further assessed intravenous golimumab 2 mg/kg effi cacy/safety in a larger patient population, while also evaluating a different dosing strategy (induction dosing at weeks 0 and 4, followed by q8-week maintenance therapy; see online supplementary fi le) to establish an efficacious dosing regimen for long-term maintenance therapy with intravenous golimumab. PATIENTS AND METHODS PatientsAdults with active RA despite MTX (stable regimen of 15-25 mg/week for ≥4 weeks) for ≥3 months were enrolled. Active RA was defi ned by ≥6/66 swollen joints and ≥6/68 tender joints at screening and baseline, rheumatoid factor positive and/or anticyclic citrullinated protein-positive at screening, and a screening C-reactive protein (CRP) concentration ≥1.0 mg/dl (upper limit of normal (ULN): 1.0 mg/dl). Patients were naïve to prior anti-TNF treatment. Stable (≥2 weeks) approved regimens of non-steroidal anti-infl ammatory drugs and/or oral corticosteroids (≤10 mg/day) were allowed. Additional details of patient eligibility criteria are provided online. Study designThe study (NCT00973479, EudraCT 2008-006064-11) was conducted according to the ▶ Additional materials are published online only. To view these fi les please visit the journal online (http://ard.bmj.com/ content/early/recent) ABSTRACTObjectives Evaluate the effi cacy of intravenous golimumab 2 mg/kg+methotrexate (MTX) in patients with active rheumatoid arthritis (RA) receiving MTX. Methods Patients (n=592) with active disease (≥6/66 swollen, ≥6/68 tender joints, C-reactive protein ≥1.0 mg/dl, rheumatoid factor positive and/or anticyclic citrullinated protein antibody positive at screening) despite MTX (15-25 mg/week) participated in this double-blind, placebo-controlled, phase 3 study. Patients were randomised (2:1) to receive intravenous golimumab 2 mg/kg, or placebo infusions at weeks 0 and 4 and every (q) 8 weeks; patients continued MTX. Placebo patients with <10% improvement in combined swollen/tender joint counts at week 16 could early escape to intravenous golimumab 2 mg/kg. The primary endpoint was week 14 American College of Rheumatology 20% (ACR20) response. Analyses employed non-responder imputation and last-observation-carried-forward. Results At week ...

ObjectivesAssess golimumab's long-term efficacy/safety in psoriatic arthritis (PsA).MethodsAdults with active PsA (≥3 swollen and tender joints, active psoriasis) were randomly assigned to subcutaneous placebo, golimumab 50 mg, or golimumab 100 mg every 4 weeks (q4wks) through wk20. All patients received golimumab 50 mg or 100 mg q4wks from wk24 forward. Methotrexate was allowed and taken by approximately half the patients. Findings through 5 years are reported herein. Efficacy assessments included ≥20% improvement in American College of Rheumatology (ACR20) response, C-reactive-protein-based, 28-joint-count Disease Activity Score (DAS28-CRP) response, ≥75% improvement in Psoriasis Area and Severity Index (PASI75) scores, and PsA-modified Sharp/van der Heijde scores (SHSs).Results126/405 (31%) randomised patients discontinued treatment through wk252. Golimumab was effective in maintaining clinical improvement through year-5 (ACR20: 62.8–69.9%, DAS28-CRP: 75.2-84.9% for randomised patients; PASI75: 60.8–72.2% among randomised patients with ≥3% body surface area involvement) and inhibiting radiographic progression (mean changes in PsA-modified SHS: 0.1–0.3) among patients with radiographic data. While concomitant methotrexate did not affect ACR20/PASI75, it appeared to reduce radiographic progression. No new safety signals were identified. Antibodies-to-golimumab occurred in 1.8%/10.0% of patients with/without methotrexate).ConclusionsLong-term golimumab safety/efficacy in PsA was demonstrated through 5 years.Trial registration numberNCT00265096.