7th annual european congress of rheumatology

7th Annual European Congress ofRheumatology21–24 June 2006; Amsterdam, The Netherlands

Fiona Cameron and Sam CrofskeyAdis International Inc., Yardley, Pennsylvania, USA

MEETING REPORT Int J Pharm Med 2006; 20 (5): 321-3261364-9027/06/0005-0321/$39.95/0

© 2006 Adis Data Information BV. All rights reserved.

The European League Against Rheumatism (EULAR) heldthe 7th Annual European Congress of Rheumatology (EULAR2006) in Amsterdam in June. EULAR represents patient, healthprofessional and scientific society interests in relation to rheumatol-ogy; EULAR aims to reduce the burden of rheumatic diseases onindividuals and society, and to improve the treatment, preventionand rehabilitation of musculoskeletal diseases.

1. Long-Term AIM for Treating Rheumatoid Arthritis (RA)

Abatacept (Orencia®)1 sustains inhibition of radiographicprogression over 2 years in patients with rheumatoid arthritis(RA) who have had an inadequate response to methotrexate ther-apy, according to new data from the extension phase of the AIM(Abatacept in Inadequate responders to Methotrexate) trial.[1]

The AIM trial was a randomised, double-blind, multicentre,phase III study involving 652 patients with RA who had not re-sponded adequately to methotrexate. Patients received fixedabatacept doses of approximately 10 mg/kg (n = 433) or placebo,in addition to their existing methotrexate regimen for 1 year;study medication was administered by a 30-minute IV infusionon days 1, 15 and 29, and every 28 days thereafter. During months6–12, patients were allowed to receive another nonbiologicaldisease-modifying antirheumatic drug (DMARD; hydroxychloro-quine, sulfasalazine or gold) in addition to their study medica-tion.

The 1-year treatment period was completed by 385 patientsin the abatacept group and 162 placebo recipients; these patientswere eligible to enter the open-label extension phase of the trial,whereby all patients received a fixed abatacept dose of approxi-mately 10 mg/kg every 28 days, in addition to their existing meth-otrexate regimen, for a further 12 months.

1.1 Radiographic Progression Minimised

Minimal radiographic progression occurred during the secondyear of therapy in patients who received abatacept for 2 years.Using a linear mixed model analysis to compare the slope ofradiographic progression over the 2-year period, treatment withabatacept for 2 years was significantly better than placebo for 1year followed by abatacept for inhibiting joint erosion (p < 0.001)and joint space narrowing (p < 0.05).

1.2 Treatment Effect Better at Second Year

Among patients who received 2 years of abatacept treatment,radiographic progression was significantly slowed during thesecond year of therapy; the mean change in Genant-modifiedSharp total score was 57% less for year 2, compared with themean change from baseline at year 1 (p < 0.0001).

“The long term extension of the AIM study shows that 2 yearsof abatacept treatment slowed progression of structural damagein rheumatoid arthritis patients, potentially providing a valuabletreatment option for those patients with an inadequate responseto methotrexate”, said Professor Harry Genant from the Universityof California, San Francisco. “It is especially interesting to notethat the effect seen at year 2 was significantly better than that seenat year 1, suggesting progressive improvement and sustainedreduction of damage which could equate to increased patientsquality of life measures such as mobility and independence.”

1.3 Clinical Benefits Sustained …

A separate analysis of the AIM trial presented at the meetingdemonstrated that abatacept provided sustained benefits forclinical and patient-reported outcomes through 2 years’ therapy.

Of patients who entered the long-term extension phase of the

1 The use of trade names is for product identification purposes only and does not imply endorsement.

trial, ACR20, ACR50 and ACR70 response rates, defined as theproportion of patients with an improvement from baseline of≥20%, ≥50% and ≥70%, respectively, according to AmericanCollege of Rheumatology (ACR) criteria, were significantlyhigher among abatacept than placebo recipients at 1 year; theseresponse rates were maintained through 2 years of abatacepttherapy.[2] Importantly, patients who switched to abatacept at thestart of the long-term extension phase experienced similar ACRresponse rates to those who received abatacept from day 1 of thedouble-blind phase. The proportions of patients achieving remis-sion (mean 28-joint Disease Activity Score [DAS28] of <2.6) andHealth Assessment Questionnaire Disability Index (HAQ-DI)response (improvement from baseline of ≥0.3 units) were alsosimilar at year 2.

1.4 … As Well as Patient-Reported Outcomes

The significant improvements in Short Form (SF)-36 physi-cal and mental component summary scores among abatacept-treated patients at the end of the double-blind phase were main-tained through 2 years of therapy. Improvements from baselinein SF-36 physical and mental component summary scores weresimilar at year 2, regardless of initial randomisation.

With respect to clinical and patient-reported outcomes, thestudy investigators note that patients switching from placebo plusmethotrexate to abatacept plus methotrexate rapidly achievedsustained improvements after 1 year that were comparable to theoriginal abatacept treatment group.[2]

2. PROMPT Use of Methotrexate Prevents RA

One of the highlights of EULAR 2006 was the presentationof the results of the PROMPT (Probable RA: Methotrexate vsPlacebo Therapy) study. Conducted by investigators from theLeiden University Medical Center in The Netherlands, thePROMPT study[3] investigated the efficacy of methotrexate forthe prevention of chronic destructive RA in patients diagnosedwith early undifferentiated arthritis. Methotrexate therapy inearly RA was also the focus of a trial[4] presented by anothergroup of researchers from The Netherlands. In this study, theeffects of early intensive therapy were compared with a conven-tional treatment regimen.

2.1 Methotrexate Delays the Development of RA: The PROMPT Study

Methotrexate therapy in patients with undifferentiated ar-thritis prevented or delayed the development of RA, according tothe results of the PROMPT study.[3] The study involved 110 pa-

tients who fulfilled the ACR 1958 criteria for probable RA, andwho had been experiencing symptoms for <2 years. Patients weretreated with methotrexate or placebo for at least 12 months. Meth-otrexate was initiated at a dosage of 15 mg/week, and the dosagewas adjusted to a maximum of 30 mg/week, based on a targetDAS28 of ≤2.4.

The results of PROMPT showed that 20% of patients treatedwith methotrexate developed RA, according to the ACR 1987criteria, compared with 29% of those treated with placebo. Ofnote, the difference between the methotrexate and placebo groupswas significant in patients who were positive for anti-citrullinated peptide (CCP), but not in those who were anti-CCP-negative. The results also showed that the time to diagnosis ofRA was significantly longer in the methotrexate group than theplacebo group (p < 0.05), according to a Kaplan-Meier survivalanalysis.

2.1.1 Window of OpportunityThe authors of the trial comment that “anti-CCP-positive

patients seem to benefit most from treatment with MTX [metho-trexate], which indicates the existence of a window of opportu-nity in anti-CCP-positive arthritic patients to influence the diseaseprogression into full-blown RA.”[3] They add that “this is the firstRCT [randomised controlled trial] that demonstrates the exist-ence of such a window of opportunity.”

Professor Tom Huizinga, one of the study investigators, con-siders the PROMPT data “excellent news” as the results show“that methotrexate appears to delay or even prevent progressionto rheumatoid arthritis.”

Another PROMPT investigator, Henrike Van Dongen, saysthat “one of the most interesting findings from the study was thatthe patients who benefited the most were the ones showing apositive anti-CCP test, which would in general terms show thata patient has a very high likelihood of developing full-blown RA;however, this study indicates that the progression to a full-blowndisease amongst these patients could be influenced.”

2.2 An Intensive Individually Tailored Regimen is Beneficial

“Intensive treatment with MTX [methotrexate] tailored tothe individual patient is clinically more beneficial than conven-tional treatment with MTX”, say Dutch investigators.[4] “Further-more, a computer assisted approach, to make more objectivelydecisions on dosage changes, is feasible in daily practice”, theyremark.

In their trial, a total of 301 patients were randomised to intensiveor conventional therapy with methotrexate.[4] Patients assignedto the intensive treatment regimen visited the outpatient clinic at

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monthly intervals, and the dosage of oral methotrexate wasadjusted to the individual patient with the goal of achieving dis-ease remission. The initial dosage was 7.5 mg/week, increasedup to 30 mg/week as required. In the conventional therapy group,patients visited the outpatient clinic every 3 months. The metho-trexate dosage range was also 7.5–30 mg/week, but the dosagewas adjusted based on daily practice. In both treatment groups,oral therapy could be switched to subcutaneous therapy if patientsfailed to achieve disease remission. Response was evaluated us-ing a computer programme.

The results showed that intensive methotrexate therapy pro-vided significant benefits over conventional therapy. A total of41% of patients in the intensive therapy group achieved diseaseremission for a period of at least 6 months, compared with just24% of those in the conventional therapy group. In addition, themedian area under the concentration-time curve (AUC) for sev-eral clinical variables, including morning stiffness, pain scores,tender and swollen joint counts, and erythrocyte sedimentationrate were significantly better with intensive therapy than conven-tional therapy.

Discontinuation rates were 33% and 19% in the intensive andconventional treatment groups, respectively.

3. Drug Development in RA

Many of the studies presented at EULAR 2006 investigateddrugs under research and development for the treatment of RA.Highlights from several of these studies are presented below,including encouraging long-term data on rituximab, disappoint-ing results for apratastat and MK 0812, and the slightly contro-versial results of a trial on tocilizumab.

3.1 ACZ 885 Looks Hopeful for Some Patients

Treatment with ACZ 885, a fully human monoclonal anti-body to interleukin-1β under development with Novartis, re-sulted in “important clinical improvement in a subset of pts [pa-tients], and was well tolerated” in patients with methotrexate-resistant RA, according to German-based investigators.[5]

Preliminary efficacy data from this phase I/II pharmacoki-netic study showed that 6 of 19 patients (32%) who received ACZ885 10 mg/kg/day and 4 of 6 patients (67%) who received 3mg/kg/day achieved a 20% response according to the ACR cri-teria, compared with just 1 of 15 placebo recipients (7%). Themaximum concentration and AUC pharmacokinetic values forACZ 885 were proportional to dose, and the drug was reportedto be well tolerated.

3.2 AMG 714 Provides Some Benefits

“The overall clinical results suggest efficacy of AMG 714 inthe treatment of DMARD-refractory RA,” conclude researchersfrom Glasgow Royal Infirmary, Scotland and Amgen.[6]

This multinational trial investigated the effects of AMG 714,a fully humanised monoclonal antibody to interleukin-15 that isbeing developed by Danish company Genmab A/S in collabora-tion with Amgen for the potential treatment of autoimmune dis-eases. A total of 180 patients who had an inadequate response toat least one DMARD were included. The results failed to show asignificant difference between placebo and the highest dose ofAMG 714 for the primary endpoint, defined as the proportion ofpatients who achieved a 20% response according to the ACRcriteria at 14 weeks. However, treatment with AMG 714, com-pared with placebo, was associated with significant improve-ments in C-reactive protein levels and erythrocyte sedimentationrates (both p < 0.01).

3.3 Apratastat Results Disappointing

“Although apratastat was generally well tolerated and safe,it failed to demonstrate efficacy in this short-term phase II study,”report investigators from Radiant Research in Dallas, TX, andWyeth Research.[7]

Apratastat is an orally active, small-molecule inhibitor oftumour necrosis factor-α (TNFα) converting enzyme and matrixmetalloproteinase that was under development with Wyeth.However, the results of this present trial failed to show any im-provement in patients treated with apratastat at dosages of up to450 mg/day, compared with those who received placebo, withrespect to the proportion of patients who achieved the ACR20response criteria.

3.4 Golimumab Gets the Go-Ahead

Currently in phase III testing, golimumab is a high-affinity,fully humanised anti-TNFα monoclonal antibody that was dis-covered through a collaboration between Medarex and Centocor(Johnson & Johnson). At EULAR 2006, investigators from Mas-sachusetts General Hospital and Centocor reported thatgolimumab improves symptoms in a significant proportion ofpatients with methotrexate-refractory RA.[8]

A total of 172 patients were randomised to treatment witheither golimumab 50 or 100mg administered every 2 or 4 weeksin combination with methotrexate at a minimum dosage of 10mg/week, or to treatment with methotrexate alone. The primaryendpoint, a 20% improvement according to the ACR20 criteriaat week 16, was met by a significantly higher proportion of

EULAR 2006 Meeting Report 323


patients in the golimumab plus methotrexate group than the meth-otrexate alone group (62% vs 37%; p < 0.01). Treatment withgolimumab was not associated with an increased incidence ofadverse events.

Additional pharmacokinetic (PK) and pharmacodynamic(PD) data on golimumab showed that there was a positive corre-lation between serum trough concentrations and improvement inmeasures of clinical efficacy. According to researchers fromCentocor, “target drug concentrations obtained from PK/PDmodelling provide supportive rationale to carry out the pivotalphase III trials with the dosing regimens of 50mg and 100mgevery 4 weeks.”[9]

3.5 MK 0812 Fails to Impress

MK 0812 does not provide any clinically meaningful bene-fits over placebo, according to researchers from Canada andMerck Laboratories.[10]

MK 0812 is an oral, small-molecule antagonist of thechemokine receptor 2 (CCR2) under development with Merck.At a dosage of 10 mg/day, MK 0812 did not improve the meanswollen joint count (primary endpoint) after 3 months’ treatment,compared with placebo. In addition, the proportion of patientswho achieved the ACR20 response criteria was actually lower inthe MK 0812 groups than the placebo group (25% and 16% vs31%).

3.6 Ofatumumab Tolerability Satisfactory

Ofatumumab has an acceptable tolerability profile in patientswith RA who had failed to respond to DMARDs, say researchersfrom Hvidovre Hospital in Denmark and Genmab A/S.2 [11] Theysuggest that the tolerability data from their trial support furtherclinical development of ofatumumab in patients with RA.

In this small trial (n = 39), patients were treated with twodoses of ofatumumab 300, 700 or 1000mg. Preliminary efficacydata showed greater improvements in ofatumumab recipientsthan placebo recipients. Two serious adverse events were reported,both of which were related to the infusion of ofatumumab 300mg.Other adverse events included grade 1–2 rash, hypotension,fever, nausea and flushing.

3.7 Rituximab Efficacy Sustained: DANCER and REFLEX

The 1-year results of the Dose-ranging Assessment iNter-national Clinical Evaluation of Rituxumab in RA (DANCER)trial “support the long term benefits” of rituximab in patients with

an inadequate response to DMARDs, say researchers involved inthis trial.[12]

After treatment with a single course of rituximab (500 or1000mg doses administered on day 1 and 15), the ACR20 re-sponse criteria were met by 67% and 59% of those in the 500mgand 1000mg groups at 48 weeks, respectively, compared with45% of those in the placebo group. The corresponding remissionrates were 16% and 10% versus 5%.

“The majority of pts [patients] who withdrew did so to re-ceive further courses of RTX [rituximab] between weeks 24 and48,” say the investigators.[12]

In the Randomised Evaluation oF Long-term Efficacy ofrituXimab in RA (REFLEX) trial, a long-term response wasachieved in some patients who had previously had an inadequateresponse to TNFα antagonists.[13] Rituximab [Rituxan®,MabThera®] is a mouse/human chimeric rDNA pan-B antibodythat targets the CD20 cell surface marker.

The trial included 517 patients receiving concomitant meth-otrexate. At the 48-week follow-up period, the proportion of pa-tients who remained on therapy was higher in the rituximab groupthan the placebo group (37% vs 11%), and the ACR20 responsecriteria were met by 51% and 33% of patients, respectively.

3.8 TgAAC 94 Tolerability Data Promising

“A single dose of IA [intra-articular] tgAAC94 appears to besafe and well-tolerated”, report researchers from Swedish Medi-cal Center, Seattle, WA, and Targeted Genetics Corporation.[14]

Interim data were available for 21 patients, including 10 whowere receiving concomitant TNFα antagonists. During a follow-up period of 8–12 weeks, there were no reports of clinically relevantadverse events in patients who had received a single dose oftgAAC 94.

3.9 Tocilizumab Appears to be More Effective than Methotrexate

The investigators from Osaka University, Japan, found thattocilizumab monotherapy significantly improved the signs andsymptoms of RA patients refractory to methotrexate.[15]

In this trial, the effects of tocilizumab 8 mg/kg administeredevery 4 weeks over a 24-week period were compared with thoseof methotrexate 8 mg/week. At 24 weeks, the proportion ofpatients who had a 20% response according to the ACR criteriawas significantly higher in the tocilizumab group than the meth-otrexate group (80% vs 25%; p < 0.001).

2 Genmab is developing ofatumumab (HuMax-CD20), a fully human, high-affinity immunoglobulin G1 (IgG1) κ antibody targeted against the CD20antigen in B-cell membranes, for the treatment of cancer and rheumatoid arthritis.



Tocilizumab is a humanised anti-interleukin-6 monoclonalantibody, which was originated by the Japanese company ChugaiPharmaceutical and is being co-developed with Roche.Tocilizumab is available in Japan for the treatment ofCastleman’s disease and has been filed for approval for the treat-ment of RA.

3.9.1 Some Controversy over TrialThe results of this trial provoked some controversy at the

EULAR meeting. It was pointed out by an attendee that the dos-age of methotrexate used in this trial was possibly too low to beeffective. However, the presenter indicated that 8 mg/week is therecommended dosage for methotrexate in Japan.

4. Recent Research in Juvenile RA

Several presentations at EULAR 2006 included promisingdata with respect to treatments for patients with juvenile RA(JRA). Key details from some of these trials are presented below.

4.1 Adalimumab has Sustained Efficacy

Adalimumab maintenance therapy reduces the rate of dis-ease flares in children with polyarticular JRA who respond toinitial treatment with adalimumab, according to data from a trialconducted by the Paediatric Rheumatology International TrialsOrganisation (PRINTO).[16]

A total of 133 patients aged 4–17 years, who met the ACRPediatric (ACR-Ped) 30% response criteria after 4 months’ ther-apy with adalimumab, were randomised to further treatment witheither adalimumab 24mg administered every 2 weeks, or placebo.The primary endpoint was the incidence of disease flares over the32-week double-blind treatment period.

It was revealed that the rate of disease flares was signifi-cantly lower in adalimumab than placebo recipients irrespectiveof concomitant methotrexate (p < 0.05). In addition, the propor-tions of patients who met the ACR-Ped 30%, 50% and 70% re-sponse criteria were significantly greater in the adalimumabgroup (all p < 0.01 vs placebo). Adalimumab appeared to be welltolerated in these patients.

4.2 Rilonacept Trap Active in Systemic Disease

“Preliminary results indicate that IL-1 [interleukin-1] Trapis beneficial in children with SJIA [systemic juvenile idiopathicarthritis], and may provide an effective once-weekly therapy,”say researchers from Children’s Hospital, Cincinnati, OH, andRegeneron Pharmaceuticals.[17]

They reported interim data from an ongoing multicentrestudy in which children and adolescents were treated with sub-

cutaneous rilonacept (IL-1 Trap) or placebo for 4 weeks. Of the11 patients treated, data were available for 8 patients at week 2and for 4 patients at week 4. At these timepoints, 6 and 3 patients,respectively, met the ACR-Ped 30% response criteria. Further-more, it was shown that treatment with rilonacept was associatedwith marked improvements in platelet, white blood cell,haemoglobin, D-dimer and C-reactive protein levels. Response wasobserved in some patients who had previously failed to respondto therapy with anakinra.

There were no reports of fever or rash in any patient.

4.3 Tocilizumab Maintenance Therapy in Systemic Disease

“In this first double blind study, treatment with tocilizumabresults in rapid and substantial improvement in children withSJIA [systemic juvenile idiopathic arthritis] and was generallywell-tolerated,” say investigators from Yokohama City Univer-sity School of Medicine in Japan.[18]

The trial included 56 patients who were unable to tolerate orhad an inadequate response to corticosteroids, and had achieveda response after 6 weeks’ treatment with open-label tocilizumab.Patients were randomised to treatment with a further 12 weeks oftocilizumab therapy or placebo. During the double-blind phase,the proportion of patients who withdrew due to disease relapsewas significantly lower in the tocilizumab group than the placebogroup (20% vs 83%; p < 0.001).

Two serious adverse events were reported, both of whichresolved after withdrawal of tocilizumab. Other adverse eventsincluded upper respiratory and gastrointestinal infections, andelevated liver enzyme levels.

“Tocilizumab is one of the most promising therapies to treatchildren with SJIA who are refractory to conventional therapies,”conclude the investigators.[18]

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7th annual european congress of rheumatology

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