AbbVie is seeking a legal injunction to block the European Medicines Agency (EMA) from publishing clinical trial data relating to its rheumatoid arthritis drug Humira.

The biopharmaceutical company claims that publishing the trial data would violate both commercial confidentiality and patient confidentiality.

AbbVie’s position contrasts with that of GSK, which has committed to publishing all its future and past clinical trial data, and shows that the pharma industry is becoming polarised on this issue.

The EMA has committed to publish all clinical trial data once a drug has completed marketing authorisation from the start of 2014.

The AllTrials ‘open data’ movement, which GSK now supports, has been driven by medical authorities including the Cochrane Collaboration and the BMA.

The AllTrials position is that secrecy around clinical trial data rewards dishonesty in the planning and reporting of trials, and that transparency is in the interests of all patients and all honest pharma companies.

AbbVie, which recently split off from Abbott, has the support of the European Federation of Pharmaceutical Industries and Associations (EFPIA) in seeking to protect clinical trial data as ‘confidential’.

By preventing the EMA from publishing the clinical trial data relating to Humira (adalimumab), AbbVie seeks to ensure its own right to select which data are available to prescribers and patients.

The Quality Adjusted Life Years (QALY) system for deciding which drugs should be available on the NHS is worthless, according to a European Commission report.

The three-year ECHOUTCOME project found that the key assumptions underlying NICE’s QALY evaluations are false, and decisions based on them are dangerously unreliable.

The report recommends that prescribing decisions be made relative to specific conditions and patient groups, rather than relying on a general algorithm.

NICE’s evaluation system is being considered by other European health technology assessment bodies, but ECHOUTCOME advises against its use.

The QALY system estimates the number of years of healthy life gained by the patient, with adjustments for the likely impact of the patient’s symptoms, to reach a figure for the number of Quality Adjusted Life Years (QALYs).

If the cost per QALY for each patient is estimated to be below £30,000, NICE will usually recommend the treatment.

But according to the European researchers, NICE is basing its quantitative assessments on factors that are both qualitative and ill-conceived.

The ECHOUTCOME study, conducted by six universities and several research agencies, analysed data from 1,300 respondents in Belgium, France, Italy and the UK and concluded that QALY cannot capture medical outcomes accurately.

QALY relies on four key assumptions: time and quality of life can be measured in consistent intervals; life years and quality of life are linked; patients have a neutral attitude towards risk; and willingness to sacrifice life years for quality of life is constant over time.

According to the study, these assumptions are all false, and so QALY has no valid empirical basis.

Gerard Duru, Emeritus Research Director in Mathematics at the French National Centre of Scientific Research, commented: “The underlying assumptions of the QALY outcome are very theoretical and are not verified in a real population. It is impossible to know what we are measuring, and therefore impossible to base a formula upon it.”

According to ECHOUTCOME’s Project Leader, Ariel Beresniak, a different approach is needed: “Each case is different and each should use adequate evaluation tools. There should be a list of adequate validated tools to make these decisions with guidance on when to use each.”

For example, the report recommends using a cost per remission approach to evaluate drugs treating rheumatoid arthritis, and a cost-benefit approach to evaluate drugs for wide-scale vaccinations.

The Scottish Medicines Consortium (SMC) has approved the use of RoActemra (tocilizumab) as a single therapy for rheumatoid arthritis (RA).

The Roche drug is an alternative to the standard therapy, methotrexate (MTX), which one-third of RA patients cannot tolerate.

The approval reflects the priority of helping patients to achieve remission from a chronic disease that damages the joints, leading to progressive disability.

Tocilizumab is a biological therapy: it targets specific chemical signals or receptor cells.

It has been found to offer remission rates four times better than the most prescribed alternative, adalimumab (Humira), and to offer a reduction in joint swelling and disability.

The drug is available in combination with MTX in England, but the Scottish decision represents its first approval as a monotherapy for RA.

An auto-immune disease, RA affects 646,000 people in the UK, causing disabling joint damage within a decade in 50% of cases.

Dr David Marshall, Consultant Rheumatologist at NHS Greater Glasgow & Clyde, said: “RA is a progressive disease which can lead to irreversible joint damage and disability. We need to treat patients as quickly and aggressively as possible, using the most efficacious treatments available.

“Remission in RA is achievable for many patients and this is what we should be aiming for. This news will make a real difference to the treatment of RA and to patients’ lives, who until now have had limited treatment options.”

NICE has proposed 16 new indicators for inclusion in the 2013/14 Quality and Outcomes Framework (QOF) and rheumatoid arthritis (RA) as a new clinical area.

The recommendations include four for RA, two for men with diabetes, plus indicators for COPD rehabilitation and hypertension.

Dr Gillian Leng, Deputy Chief Executive and Director of Health and Social Care at NICE, said the potential indicators “can make a real difference” to improve standards of care.

QOF is a voluntary incentive scheme that rewards GPs for implementing systematic improvements in care for patients. It operates through a points system which rewards doctors for their performance against the indicators.

Indicators for RA include GP practices creating a register of patients aged over 16, and patients being assessed for cardiovascular risk and fracture risk.

In men with diabetes, indicators focus on offering advice on erectile dysfunction and on available treatment options.

The final ‘menu’ of indicators will be decided by NHS Employers and the British Medical Association later this year.

The arthritis therapeutics market is expected to experience significant growth in the coming years, a new report predicts.

Research found that arthritis therapeutics are becoming a “gigantic attraction” for pharmaceutical companies as the condition continues to be one of the most common causes of disabilities.

Rising incidence rates of osteoarthritis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis are expected to see revenues reach $35.8 billion by 2018.

Several major pharmaceutical and biotechnology companies have already shown an interest in obtaining market share and have made investments in the potentially lucrative industry.

Pfizer, Amgen, Merck, Roche and Novartis, the report found, have increased R&D efforts in the field with several promising therapies in late-stage development.

The current pipeline includes many small molecule drugs and biologic therapies, as well as novel oral Disease-Modifying Anti-rheumatic Drugs (DMARDs).

Biologics, the report predicts, will feature heavily as the market expands and drive growth during the coming years.

Existing market leaders are also expected to benefit from the predicted demand.

Amgen’s patent on blockbuster drug Enbrel was recently extended until 2028 by the FDA following a number of court proceedings. Other well-established brands have also had their protection protected.

However, the patents for Rituxan (rituximab), Remicade (infliximab), Celebrex (celecoxib) and Humira (adalimumab) will see a number of generic alternatives enter the market.

Despite cheaper therapeutic products being made available, the report estimates the market will grow at a compound annual growth rate (CAGR) of 7.2% for the next six years.

Results from Roche’s SUMMACTA study have shown the subcutaneous (SC) formulation of Actemra (tocilizumab) met its primary endpoint when compared with an intravenous (IV) version.

The two-year study included 1,262 patients and found that the weekly convenient SC formulation showed comparable efficacy and safety to the IV monthly formulation.

Dr Hal Barron, Chief Medical Officer and Head Global Product Development, said the results may provide patients and their doctors in the future with an “important additional treatment option.”

Roche will now complete a further clinical trial, the BREVACTA study, and plans to submit data from both to the US FDA ahead of obtaining a license for the SC formulation.

Actemra is approved for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumour necrosis factor (TNF) antagonist therapies. It is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in youngsters aged two years or older.

Also in the SUMMACTA study, a similar number of patients with RA achieved an ACR20 response after 24 weeks – a measurement indicating improvement in the number of tender and swollen joints, pain scale and patients’ and physicians’ assessment of improvement, and certain laboratory markers.

“We are very pleased with these data showing that subcutaneous administration of Actemra provides clinically meaningful and comparable results to the IV infusion,” said Dr Barron.

The results of the BREVACTA study are expected later in the year.

Belgian biopharma company UCB has predicted that patent expiry will strongly affect its European growth in 2012.

While UCB’s blockbuster epilepsy drug Keppra faced little generic competition in Europe following its patent expiry in 2011, the company predicts a 50% sales fall for the product in 2012.

However, the company’s CEO said its focus on severe diseases of the immune system and CNS has helped to insulate it against economic austerity.

UCB saw its revenues rise by 1% to €3.25bn in 2011, but predicts a fall of nearly 5% to €3.1bn in 2012.

According to a UCB spokesman, Keppra faces competition from more than 100 generic substitutes in 2012, and its European sales can be expected to fall by 50%.

Delays in the launch of generic alternatives protected Keppra in 2011, when its global sales increased by 3% despite its patent expiry.

UCB’s CEO, Roch Doliveux, said that its commitment to therapy areas such as epilepsy and immunology had shielded the company from the impact of European austerity: “We still have the means in Europe for many years to come to pay for severe healthcare issues, and that’s what we’re addressing.”

Last year, UCB benefited from increased sales of three products: Vimpat for epilepsy, Neupro for Parkinson’s disease and restless legs syndrome, and Cimzia for Crohn’s disease and rheumatoid arthritis (RA).

Doliveux also argued that value-based pricing – due to be adopted by the NHS in 2014 – is not a good model to support innovation. He argued that the current PPRS system is “a very robust system that a lot of countries have tried to copy, and PPRS works well.”

Among non-UK companies, UCB is the leading non-British investor in UK pharmaceutical R&D.

Roche’s rheumatoid arthritis (RA) drug RoActemra has shown greater effectiveness than Abbott’s market-leading rival Humira in a phase IV clinical test.

The ADACTA head-to-head study indicated that RoActemra (tocilizumab) performed better on all primary and secondary measures of clinical efficacy than Humira (adalimumab).

The trial result will boost Roche’s attempts to win market share for RoActemra, whose sales rose to $675m last year – a long way behind Humira’s $7.9bn.

Preliminary analysis showed a similar safety profile for the two drugs.

However, the antibody RoActemra is only available via an hour-long intravenous infusion, whereas Humira and other TNF inhibitors can be administered by subcutaneous injection.

Roche is developing a subcutaneous injection version of RoActemra, which will be filed for regulatory approval later this year.

The ADACTA study showed that patients given RoActemra achieved a significantly greater reduction in disease activity after 24 weeks than those given Humira.

RoActemra also performed better on key secondary endpoints including remission and low disease activity.

The finding reflects the growing importance of phase IV (head to head) trials in a pharmaceutical market driven by value-based pricing.

NICE has approved the first new class of treatment for rheumatoid arthritis (RA) in over ten years.

Roche’s RoActemra (tocilizumab) is recommended for treatment of RA where standard treatment with disease modifying anti-rheumatic drugs (DMARDs) has failed.

The approval offers a new therapy option to thousands of patients suffering from this painful and disabling condition.

RoActemra, which can be used alone or with methotrexate (the most commonly used DMARD), is the first licensed Interleukin-6 (IL-6) receptor antagonist.

The combination of methotrexate and RoActemra offers a clinical remission rate at one year of 47%, compared with 8% for methotrexate alone.

Until now, the only therapy option when DMARDs failed was anti-tumour necrosis factor inhibitors, which offer a clinical remission rate of 19%.

John Isaacs, Professor of Clinical Rheumatology at the Institute of Cellular Medicine, Newcastle University, said: “IL-6 receptor inhibition is an innovative and highly effective approach to the treatment of RA and NICE’s decision to recommend RoActemra in this setting provides an important addition to the armoury of treatments needed to combat the condition.

“RA is an unrelenting disease and it is vital that patients have options available to them when they are no longer responding to, or can no longer tolerate, their current treatment.”

“We are delighted with NICE’s decision, as there are so many patients with rheumatoid arthritis in need of tighter disease management,” commented Ailsa Bosworth, Chief Executive of the National Rheumatoid Arthritis Society.

“We are very supportive of more aggressive implementation of NICE RA Guidelines and treat to target strategies which, with earlier referral and diagnosis, are more likely to enable patients to reach remission or low disease activity.”

The CHMP has adopted a positive opinion on MSD’s Remicade (infliximab) for the treatment of severely active ulcerative colitis (UC) in youngsters aged between 6 to 17 years old.

The Committee recommends the monoclonal antibody for those who have had an inadequate response to conventional therapy, or who are intolerant to medical contraindications for such therapies after a Phase III study demonstrated its efficacy.

Rupert Vessey, Senior Vice President, Research Laboratories, Merck, says the positive opinion is “encouraging news and a significant step” for younger patients in Europe.

If the medication if subsequently approved by the European Commission, it will be the first and only biologic therapy approved in the EU for the treatment of paediatric UC.

Paediatric UC is a debilitating condition that causes inflammation and painful swelling of the inner lining of the large intestine.

In clinical trials, Remicade demonstrated its efficacy in a Phase III, 54 week study in 60 youngsters diagnosed with moderately to severe active UC who had experienced an inadequate response to conventional therapies. In March 2006, it was approved in the EU for the treatment of moderately to severely active UC in adults.

Remicade also approved for use in Europe for:

• Severe, active Crohn’s disease in adult patients
• Fistulising, active Crohn’s disease in adult patients
• Rheumatoid Arthritis (in combination with methotrexate)
• in adult patients with active Rheumatoid Arthritis
• Severe, active ankylosing spondylitis in adult patients
• Active and progressive psoriatic arthritis in adults
• Moderate-to-severe plaque PsO in adults
• Moderately-to-severely active UC in adults
• Severe, active Crohn’s disease in paediatric patients aged 6 to 17 years old.

A decision from the European Commission on the CHMP’s recommendation is expected during the first quarter of 2012.