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Tocilizumab (Actemra/RoActemra) Review
rheumatoid arthritis, interleukin 6, mAbs, FDA approval, EMEA approval, ADRs, sales, projections, forecast, market launch
Actemra (Tocilizumab) is the new drug from Roche/Chugai/Genentech to be approved by the FDA in 2010. It is to treat rheumatoid arthritis patients refractory to existing drugs and is marketed in Europe. FDA rejected the advice of its advisory panel in 2008 and asked for additional data about the manufacturing controls. Reports of links to serious adverse events in Japan did not result in further delays. Roche says that the marketing uptake of the drug has been good in 8 European countries, Japan, India and Brazil with sales of $140 million in 2009. It is the first monoclonal antibody which targets Interleukin 6 and offers an alternative to 30% of arthritis patients not responding to or intolerant of TNF blockers. The cost of the drug may be in the range of $1060-2125 per month of treatment depending on the dose used. It is the 8th biologic to be approved for arthritis patients. Roche reported global sales of $ 315 million for the year 2010.
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Introduction
Tocilizumab (Actemra) is a humanized mAbs which blocks inflammatory cytokine interleukin 6 (IL6) receptor . IL6 is one of the contributory factor in the rheumatoid arthritis. Clinical studies in RA patients have shown benefits of the treatment in reducing joint inflammation, joint damage and fatigue. It has been hailed and touted as the new blockbuster mAbs from Chugai/Roche to treat arthritis and two recent reviews were published in latest editions of Nature Review Drug Discovery (with IMS sales projections) and in Adis Drugs (Industry sponsored drug reviews). These reviews were well timed to coincide with market launch of the brand in Europe . It was approved in Japan last year and by EMEA in January 2009.
Nomenclature| Prefix | Sub stem A | Sub stem B | Suffix common |
| Toci | li | zu | mab |
| Innovator choice | immunomodulator | humanized | monoclonal antibody |
Tocilizumab is a humanized monoclonal antibody for the immune system.
Arthritis Images
Under Creative Commons Attribution 3.0 License Kindly Provided by Roche www.roche.com Photolibrary Rheumatoid arthritis starts with inflammation of the lining of the joint - the synovium - followed by destruction of the underlying cartilage, and then the bone itself. Image 0050815 jpg
Image 0050814 jpg An Inflammed and Swollen knuckle joint 
Actemra Image 
From Wikipedia http://en.wikipedia.org/wiki/Monoclonal_antibody 
Microsoft Office Clip Art Medical images
Trade name RoActemra in Europe Actemra outside EU.
YouTube Video
YouTube Video
Interleukin 6
From Roche/Chugai http://www.roactemra.com/portal/eipf/pb/actemra/roactemra/mechanism_of_action
The role of interleukin 6 in the pathogenesis of rheumatoid arthritis is explained in Roche slides presented to the FDA arthritis drug advisory committee in July 2008.
What is IL-6?
Interleukin-6 (IL-6), the most abundant cytokine found in patients who suffer from rheumatoid arthritis, plays a major role in inflammation that leads to joint destruction, pain and fatigue.
Where in the body is IL-6 manufactured?
IL-6 is made by various cells and is found in the inflamed joint cavities of patients with rheumatoid arthritis. Excessive IL-6 in other parts of the body may even decrease haemoglobin levels by locking iron away, which could lead to anaemia.
How does IL-6 work?
The IL-6 cytokine attaches itself to cell-specific (above) or soluble (below) receptors that float freely in the body. Once attached, a message is sent to cells where inflammation is then activated or amplified.
Image from Orencia web site.
IL-6 Role in RA (Roche slides to the FDA advisory committee)IL-6 Role in RA (Roche sl...e FDA advisory committee)
Clinical Efficacy
Roche/Chugai registration dossier had 5 double blind studies involving 3778 treated RA patients with tocilizumab. There were 979 placebo control patients and 546 patients were treated with a lower dose of 4 mg/kg body weight. Over 2792 patients were treated with a dose of 8mg/kg body weight iv every 4 weeks. The majority of RA patients in the studies were female, caucasian and with positive rheumatoid factor. Treatment with tocilizumab resulted in significant increases in clinical response as measured by ARA 20, 50 and 70% response scores. Treatment with the new mAbs was associated with increased risk of serious infections and elevated liver enzymes. Malignancies, GI perforations and demyelinating adverse events were reported in clinical trials.
The results of a 2 year LITHE study in 1200 RA patients in 15 countries and 137 sites were released during the American College of Rheumatologist meeting in October 2009. The study was randomoized double blind for a year followed by open label extension for the second year. Tocilizumab was given at 4mg/kg or 8 mg/kg with or without methotrexate and the open label extension was at 8mg/kg dose. Methotrexate prevented disease progression in 66% of RA patients vs 75% of patients by 4 mg dose and 83% of patients receiving 8 mg dose. More than 33% of patients who failed DMARDs therapy had disease remission with tocilizumab. At 8 mg dose, 48% of RA patients showed clinically proven disease remission and 65% achieved it after 2 years of treatment.
Genentech Reveals Data From Phase III Trials For Actemra As ...
RTT News - 4 days ago
... were meant to assess the efficacy and safety profile at 24 weeks in rheumatoid arthritis patients who received Actemra or tocilizumab as a monotherapy, ...Data Showed ACTEMRA Monotherapy
Draft guidance from UK's NICE recommends Roche's RoActemra for ...
The Pharma Letter (subscription) - Oct 27, 2011
The draft recommendation is for the use of tocilizumab in children and young people aged two years and older, where specific previous treatments have not ...
Safety
In March 19, 2009, a Chugai press release stated that Actemra has been linked to 15 suspected deaths in Japan in within 10th month of marketing (Reuters news alert) . In addition the drug was linked with 221 cases of serious adverse reactions. These are very high numbers as only 5000 patients were treated with the drug in Japan. Roche web site and Roche Actemra site (checked May 14, 2009 and August 14, 2009 ) do not mention this important adverse event alert. Under current regulations Roche has the obligation to inform regulatory authorities of all countries where it is marketed or under regulatory review. There every reason to believe that Roche has complied with current regulations. Chugai has been regularly updating the adverse event information at its Japanese web site (Reuters alert). This information was not available at its English web site. This is not a local affiliate affair in a local language but assumes global importance due to high incidence of deaths >3 per 1000 and serious adverse drug reactions >4.5% of treated patients.
The most common ADE reported from the LITHE study were pneumonia, cellulitis, gastrointestinal troubles, bronchitis, hypertension, elevated transaminases and urinary and upper respiratory track infections. Pooled data from 3 Phase III studies and 4000 patients was used to do a new safety analysis. The risk of malignancies from prolonged immune suppression was included.
http://www.roactemra.com/portal/eipf/pb/actemra/roactemra/safety_and_tolerability
The prescribing information or packed insert carries a Black Box warnings about serious adverse reactions. Serious side effects associated with ACTEMRA include serious infections that may lead to hospitalization or death, gastrointestinal perforations (a hole in the stomach or intestines), and hypersensitivity reactions including anaphylaxis. The most common AEs reported in clinical studies were upper respiratory tract infection, nasopharyngitis (inflammation of the nose and throat), headache, high blood pressure and increased liver enzymes. The increases in liver enzymes that were seen in patients were generally mild and reversible and did not result in apparent permanent or clinically evident hepatic injury. Laboratory changes, including increases in total cholesterol, the amount of fat circulating in the blood, and decreases in neutrophils (one of the cell types that helps fight infections) and platelets, were seen. Treatments that suppress the immune system, such as ACTEMRA, may cause an increase in the risk of cancer.
http://www.actemra.com/pdf/medication_guide.pdf
April 15, 2011 - FDA approves Actemra to treat rare form of juvenile arthritis
Approved Indications
Japan : Castelman's diseaseRheumatoid Arthritis
Juevenile Idiopathic Arthritis
EMEA: Rheumatoid Arthritis Juvenile Idiopathic Arthritis
USA: Rheumatoid Arthritis (refractory or non responders) under REMS, Juvenile Idiopathic Arthritis
Market Launch
Roche received market approval from EMEA in January 2009 and has launched Actemra in 7 EU countries plus India and Brazil. The 2Q report states strong uptake of the drug in Japan and Germany. Sales data for 2Q2009 was not provided. The product was launched in the US in the 3rd week of January, 2010 and had global sales of $ 315 million for the year.
Tocilizumab is in trials for a variety of indications like Graves Ophthalmopathy, polychondritis, AS, and Adult Still Disease.
http://clinicaltrials.gov/ct2/results?term=Tocilizumab
| Found 44 studies with search of: | Tocilizumab | Open Studies |
Display Options| 1 | Recruiting | Arthritis Patients Treated With Tocilizumab or Methotrexate" href="http://clinicaltrials.gov/ct2/show/NCT01245452?term=Tocilizumab&recr=Open&rank=1" style="color: rgb(0, 0, 204);">Comparative Study of the Clinical Response and Cardiorespiratory Endurance in Early Rheumatoid Arthritis Patients Treated With Tocilizumab or Methotrexate
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| 2 | Recruiting | A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
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| 3 | Not yet recruiting | Tocilizumab Treatment in Graves Ophthalmopathy (Graves Orbitopathy or Thyroid Eye Disease)
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| 4 | Not yet recruiting | Tocilizumab for Relapsing Polychondritis
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| 5 | Recruiting | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs
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| 6 | Recruiting | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy
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| 7 | Not yet recruiting | A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
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| 8 | Not yet recruiting | Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)" href="http://clinicaltrials.gov/ct2/show/NCT01235507?term=Tocilizumab&recr=Open&rank=8" style="color: rgb(0, 0, 204);">A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)
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| 9 | Recruiting | A Study of Tocilizumab in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis
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| 10 | Not yet recruiting | A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor
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| 11 | Not yet recruiting | Efficacy and Safety of Tocilizumab in Adult's Still Disease
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| 12 | Recruiting | A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
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| 13 | Recruiting | A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)
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| 14 | Not yet recruiting | A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis
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| 15 | Recruiting | A Study of Tocilizumab [RoActemra/Actemra] Versus Adalimumab in Patients With Rheumatoid Arthritis
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| 16 | Recruiting | A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis
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| 17 | Not yet recruiting | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
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| 18 | Not yet recruiting | A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.
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| 19 | Not yet recruiting | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS
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| 20 | Recruiting | A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)
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 | Previous Page | Studies Shown (1-20) | Next Page (21-40) |  |
Sales Forecast
For IMS it is a great new potential blockbuster and IMS has projected sales of over $1 billion within 2 years of its launch and approval in USA and Europe . Analysts have provided peak sales estimates of over 5 billion for Actemra. My peak sales estimate for Actemra is about $2.5 billion and it may take 3 years to reach blockbuster sales. Roche reported sales in 2009 were $ 140 million.
A full report is available on commercial terms.
R&D mAbs IL6
Regeneron has a promising tocilizumab follow up (REGN 88) in Phase II/III trials in RA and Phase II trials in AS. Tocilizumab (iv) has RA efficacy comparable to TNF blockers and is active in TNF failure cases as well. REGN is a fully human mAbs which targets IL6 with much higher affinity and binding specificity and can be given by sc route. Common ADR observed in CT with REGN 88 were RA flare, liver enzyme (ALT) elevation, neutropenia and upper respiratory tract infections
Early Stage Development: Peter Powchik, M.D., Senior Vice President, Clinical Development Market Potential of non TNF biologics in RA
The market domination by TNF blockers has raised the safety and efficacy bar very high for new drugs.
The marketed interleukin I receptor anatagonist Anakinra ( Kineret, Amgen) failed to find a niche market in RA. Other biologics inhibiting T cell activation like Raptiva (Genentech, withdrwan due to serious side effects and deaths), Amieve (Biogen Idec, market failure) and Orencia (BMS) have failed to gain market share in the RA, Ps, UC, CD, PsA, AS, JRA market. However the number and % of RA non responders to TNF agents has increased to around 30% of the treated patients. Orencia has steadly gained market share, had sales of $ 600 million in 2009 and may cross $1 billion sales mark in 2012. YouTube Video
FDA Approval
Actemra becomes the first new molecular entity (biologic, monoclonal antibody) to be approved by the FDA in 2010.
The registration dossier consisted of studies in over 4000 RA patients in 41 countries. In July 2008, the FDA Arthritis Advisory Committee voted for approval by 10 to 1 margin. FDA in a complete response letter asked Roche to submit plans for its REMS strategy, medication guide and training for healthcare providers and requested additional preclinical reproductive studies. Roche has submitted its complete response to the FDA on July 31, 2009. FDA had to make a decision within 6 months that is before January 31, 2010.
There was no mention of serious adverse drug reactions reported and linked to the study drug in Japan. An international web site has been set up which mentions the adverse events reported in the clinical trials but there was still no mention of post marketing adverse events in Japan
Actemra was approved by the FDA on January 8, 2010 according to Roche/Genentech. It is approved for moderate to severe rheumatoid arthritis patients who are refractory to existing RA drugs. The approval was under the stringent Risk Evaluation and Minimization Strategy which includes a medication guide, communication plan and a timetable for submission of assessments and adverse events. REMS provide support and education to patients and healthcare providers. The drug can be given by intravenous injection or infusion once a month and can be used alone or with methotrexate and DMARDs and after the use and failure of at least one tumor necrosis factor antagonist. It is contraindicated with the widely used TNF blockers biologics and monoclonal antibodies. Wider use of biologics need careful monitoring and regular follow up under FDA stringent REMS (Risk Evaluation and Minimization Strategy). The approved prescribing information carries a Black Box warnings about the serious adverse reactions. These safety concerns include elevated liver enzymes, elevated Low-density lipoprotein (LDL) or bad cholesterol, hypertension, and gastrointestinal perforations.
The FDA is requiring the sponsor to conduct a post-marketing clinical trial to further evaluate the long-term safety of Actemra. Specifically, the FDA wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with Actemra.
January 11, 2010 - FDA Approves New Drug for Rheumatoid Arthritis
FDA Approves ACTEMRA (tocilizumab) for the Treatment of Moderately to Severely Active Rheumatoid Arthritis Roche: FDA Approves Actemra For Rheumatoid Arthritis
Wall Street Journal - 7 hours ago STOCKS NEWS EUROPE-Roche gains as US clears arthritis drug Reuters FDA OKs Drug for Refractory RA MedPage Today eFitnessNow - New York Times - San Francisco Chronicle - dBTechno
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http://www.emea.europa.eu/humandocs/PDFs/EPAR/RoActemra/H-955-PI-en.pdf
Rheumatoid ArthritisBy Kenneth H. Fye, MD
Approach to a Swollen JointBy Kenneth H. Fye, MD Acknowledgements
Thanks are due to Mr. Jean-Antoine de Mandato (PDP, Geneva) for providing office facilities and administrative support.
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References
M Hirao, J Hashimoto, H Tsuboi, A Nampei, H Nakahara, N Yoshio, T Mima, H Yoshikawa and N Nishimoto. (2009). Laboratory and febrile features after joint surgery in patients with rheumatoid arthritis treated with tocilizumab. Published Online First: 2 June 2008. doi:10.1136/ard.2008.090068. Annals of the Rheumatic Diseases 2009; 68:654-657.
Long-term safety and efficacy of tocilizumab, an anti-interleukin-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study
Norihiro Nishimoto, Nobuyuki Miyasaka , Kazuhiko Yamamoto , Shinichi Kawai , Tsutomu Takeuchi and Junichi Azuma
Ann Rheum Dis. Published Online First: 19 November 2008. doi:10.1136/ard.2008.092866
Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition therapy.
Norihiro Nishimoto, Nobuyuki Miyasaka, Kazuhiko Yamamoto, Shinichi Kawai, Tsutomu Takeuchi, Junichi Azuma and Tadamitsu Kishimoto. Modern Rheumatology. Volume 19, Number 1 / February, 2009. 10.1007/s10165-008-0125-1.
Ryuji Koike1, 2, 3 , Masayoshi Harigai1, 3, Tatsuya Atsumi4, Koichi Amano5, Shinichi Kawai6, Kazuyoshi Saito7, Tomoyuki Saito8, Masahiro Yamamura9, Tsukasa Matsubara10 and Nobuyuki Miyasaka
Infectious Complications of Biologic Agents
Rheumatic Disease Clinics of North America, Volume 35, Issue 1, February 2009, Pages 183-199
Emilio Martin-Mola, Alejandro Balsa
Interleukin-6 as a key player in systemic inflammation and joint destruction
Autoimmunity Reviews, Volume 8, Issue 7, June 2009, Pages 538-542
J.E. Fonseca, M.J. Santos, H. Canho, E. Choy
Prospective new biological therapies for rheumatoid arthritis
Autoimmunity Reviews, In Press, Corrected Proof, Available online 26 March 2009
Ladislav enolt, Ji Vencovsk.5, Karel Pavelka, Caroline Ospelt, Steffen Gay
Modle d'impact budgtaire du rituximab utilis aprs chec d'un ou de plusieurs agents anti-TNF dans le traitement de la polyarthrite rhumatode
Revue du Rhumatisme, Volume 75, Issue 12, December 2008, Pages 1229-1236
Robert Launois, Stphanie Payet, Nathalie Saidenberg-Kermanac'h, Camille Francesconi, Lionel Riou Frana, Marie-Christophe Boissier
Juvenile Rheumatoid Arthritis (JRA) Affects 300000 Kids; Learn About Therapie
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